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Effect of Intravitreous Anti–Vascular Endothelial Growth Factor vs Sham Treatment for Prevention of Vision-Threatening Complications of Diabetic RetinopathyThe Protocol W Randomized Clinical Trial

Educational Objective
To determine the efficacy of intravitreous aflibercept injections compared with sham treatment in preventing potentially vision-threatening complications in eyes with moderate to severe nonproliferative diabetic retinopathy.
1 Credit CME
Key Points

Question  Does aflibercept treatment of moderate to severe nonproliferative diabetic retinopathy prevent vision-threatening complications and benefit visual acuity compared with sham treatment?

Findings  In this randomized clinical trial of 328 adults (399 eyes) with nonproliferative diabetic retinopathy without center-involved diabetic macular edema, the 2-year rate of developing center-involved diabetic macular edema with vision loss or proliferative diabetic retinopathy was 16.3% with aflibercept vs 43.5% with sham. The difference between aflibercept and sham in 2-year mean visual acuity change was 0.5 letters.

Meaning  In this study, aflibercept injections reduced the development of vision-threating complications; however, through 2 years, preventive treatment did not confer visual acuity benefit compared with observation plus aflibercept if complications developed.

Abstract

Importance  The role of anti–vascular endothelial growth factor injections for the management of nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) has not been clearly established.

Objective  To determine the efficacy of intravitreous aflibercept injections compared with sham treatment in preventing potentially vision-threatening complications in eyes with moderate to severe NPDR.

Design, Setting, and Participants  Data for this study were collected between January 15, 2016, and May 28, 2020, from the ongoing DRCR Retina Network Protocol W randomized clinical trial, conducted at 64 US and Canadian sites among 328 adults (399 eyes) with moderate to severe NPDR (Early Treatment Diabetic Retinopathy Study severity level, 43-53), without CI-DME. Analyses followed the intent-to-treat principle.

Interventions  Eyes were randomly assigned to 2.0 mg of aflibercept injections (n = 200) or sham (n = 199) given at baseline; 1, 2, and 4 months; and every 4 months through 2 years. Between 2 and 4 years, treatment was deferred if the eye had mild NPDR or better. Aflibercept was administered in both groups if CI-DME with vision loss (≥10 letters at 1 visit or 5-9 letters at 2 consecutive visits) or high-risk proliferative diabetic retinopathy (PDR) developed.

Main Outcomes and Measures  Development of CI-DME with vision loss or PDR through May 2020, when the last 2-year visit was completed.

Results  Among the 328 participants (57.6% men [230 of 399 eyes]; mean [SD] age, 56 [11] years), the 2-year cumulative probability of developing CI-DME with vision loss or PDR was 16.3% with aflibercept vs 43.5% with sham. The overall hazard ratio for either outcome was 0.32 (97.5% CI, 0.21-0.50; P < .001), favoring aflibercept. The 2-year cumulative probability of developing PDR was 13.5% in the aflibercept group vs 33.2% in the sham group, and the 2-year cumulative probability of developing CI-DME with vision loss was 4.1% in the aflibercept group vs 14.8% in the sham group. The mean (SD) change in visual acuity from baseline to 2 years was −0.9 (5.8) letters with aflibercept and −2.0 (6.1) letters with sham (adjusted mean difference, 0.5 letters [97.5% CI, −1.0 to 1.9 letters]; P = .47).

Conclusions and Relevance  In this randomized clinical trial, among eyes with moderate to severe NPDR, the proportion of eyes that developed PDR or vision-reducing CI-DME was lower with periodic aflibercept compared with sham treatment. However, through 2 years, preventive treatment did not confer visual acuity benefit compared with observation plus treatment with aflibercept only after development of PDR or vision-reducing CI-DME. The 4-year results will be important to assess longer-term visual acuity outcomes.

Trial Registration  ClinicalTrials.gov Identifier: NCT02634333

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Article Information

Accepted for Publication: February 19, 2021.

Published Online: March 30, 2021. doi:10.1001/jamaophthalmol.2021.0606

Corresponding Author: Adam R. Glassman, MS, Jaeb Center for Health Research, 15310 Amberly Dr, Ste 350, Tampa, FL 33647 (drcrstat2@jaeb.org).

Author Contributions: Mr Glassman had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Glassman, Antoszyk, Blodi, Jampol, Martin, Stockdale, Punjabi, Sun.

Acquisition, analysis, or interpretation of data: Maturi, Glassman, Josic, Antoszyk, Blodi, Jampol, Marcus, Martin, Melia, Salehi-Had, Punjabi, Sun.

Drafting of the manuscript: Maturi, Glassman, Josic, Jampol, Sun.

Critical revision of the manuscript for important intellectual content: Maturi, Antoszyk, Blodi, Jampol, Marcus, Martin, Melia, Salehi-Had, Stockdale, Punjabi, Sun.

Statistical analysis: Glassman, Josic, Melia, Punjabi.

Obtained funding: Glassman, Jampol, Martin, Sun.

Administrative, technical, or material support: Glassman, Blodi, Salehi-Had, Stockdale, Punjabi.

Supervision: Maturi, Glassman, Antoszyk, Blodi, Martin, Melia, Salehi-Had, Punjabi, Sun.

Conflict of Interest Disclosures: Dr Maturi reported receiving personal fees from Jaeb Center for Health Research during the conduct of the study; personal fees from Aerpio, Allegro, Allergan, Eli Lilly, Genentech, Graybug, Kalvista, and Santen outside the submitted work. Mr Glassman reported receiving grants from the National Eye Institute, Regeneron, and JDRF during the conduct of the study; and grants from Genentech outside the submitted work. Dr Josic reported receiving grants from National Institutes of Health and JDRF; nonfinancial support and funding for clinical trial costs from Regeneron during the conduct of the study; and nonfinancial support and funding for clinical sites from Genentech outside the submitted work. Dr Antoszyk reported receiving personal fees from Jaeb Center for Health Research during the conduct of the study; grants from Jaeb Center for Health Research, Roche, and Genentech; and personal fees from Opthea and Clearside outside the submitted work. Dr Jampol reported receiving grants from the National Eye Institute during the conduct of the study. Dr Marcus reported receiving grants from Genentech/Roche, Allergan, Aiviva, Amgen, Boehringer Inglheim, Alcon, Aerpio, Kalvista, Ionis, Mylan, Samsung, Novartis, Opthea, Chenghdhu, Clearside, Astellas, Allegro, Alimera, Iveric/Opthotech, Gemini, Regeneron, Thrombogenics, Tyrogenex, Graybug, Topcon, Optos, Xplore, Gyroscope, Stealth, Aerie, Apellis, Ohr, Regenxbio, Kodiak, Zeiss, and Genentech/Roche during the conduct of the study. Ms Melia reported receiving grants from the National Eye Institute and Juvenile Diabetes Foundation; and study drug and funds to defray clinical site costs from Regeneron during the conduct of the study. Ms Stockdale reported receiving grants from the National Institutes of Health, JDRF, and Regeneron during the conduct of the study; and grants from Genentech outside the submitted work. Dr Sun reported receiving grants from Jaeb Center for Health Research during the conduct of the study; and nonfinancial support from Optovue, Boston Micromachines, Merck, Novartis, Novo Nordisk, Adaptive Sensory Technologies, Boehringer Ingelheim, Roche, and Kalvista; and grants from Physical Sciences Inc, Kalvista, Novo Nordisk, Boehringer Ingelheim, and Roche outside the submitted work. No other disclosures were reported.

Funding/Support: This study was supported through a cooperative agreement from the National Eye Institute and the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, US Department of Health and Human Services EY14231. Regeneron provided aflibercept for the study and funds to DRCR Retina Network to defray the study’s clinical site costs. Additional grants to the Jaeb Center for Health Research from the JDRF. Network chairs, coordinating center staff, committee members, and the reading center staff are all compensated for their work as members of the DRCR Retina Network.

Role of the Funder/Sponsor: As per the DRCR Retina Network Industry Collaboration Guidelines (https://public.jaeb.org/drcrnet/view/Investig_Info) the DRCR Retina Network had complete control over the design of the protocol, ownership of the data, all editorial content of presentation and publication related to the protocol, and the decision to submit the manuscript for publication. The National Institutes of Health participated in oversight of the conduct of the study and review of the manuscript but not directly in the design or conduct of the study, nor in the collection, management, analysis, or interpretation of the data, or in the preparation of the manuscript.

The DRCR Retina Network members: Coordinating Center staff: Jaeb Center for Health Research (JCHR), Tampa, FL (staff as of January 1, 2021): Adam R. Glassman, MS (JCHR Interim Executive Director and DRCR Retina Network Principal Investigator), Roy W. Beck, MD, PhD (JCHR President), Alyssa Baptista, BS, Wesley T. Beaulieu, PhD, Claire T. Boyle, MS, Sharon R. Constantine, BS, Isabella Correia, Brian B. Dale, Simone S. Dupre, BS, Sandra Galusic, MSPH, Meagan Huggins, BA, Paula A. Johnson, MPH, Kristin Josic, PhD, Brittany Kelly, MS, Danni Liu, MSPH, Brenda L. Loggins, BS, Maureen G. Maguire, PhD, Michele Melia, ScM, Carin M. Preston, MPH, Cynthia R. Stockdale, MSPH, and Katie Stutz, BS. Duke Reading Center staff: Katrina Postell Winter, BS (Lead Reader), Garrett Thompson, MD (Reader), Dee Busian, BA (Reader), Glenn J. Jaffe, MD (Director of Grading), Adiel Mora, BA (Project Manager), Lucia Foster, MA (Project Manager Assistant), and John Keifer McGugan, BS (Project Manager Assistant). Fundus Photograph Reading Center: University of Wisconsin–Madison: Barbara Blodi (Principal Investigator), Amitha Domalpally, Nancy Barrett, Ellie Corkery, Jim Reimers, Kristi Dohm, Ruth Shaw, Sheila Watson, Wendy Benz, Pam Vargo, Andy Ewen, and Daniel Lawrence. DRCR.net Network Chairs: Jennifer K. Sun, MD, MPH (Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology) (2018-present), Daniel F. Martin, MD (Cole Eye Institute, Cleveland Clinic) (2018-present), and Lee M. Jampol, MD (Feinberg School of Medicine, Northwestern University) (2013-2017). DRCR.net Vice Chairs: Carl W. Baker, MD (Paducah Retinal Center) (2011-2013, 2017-2019), Chirag Jhaveri, MD (Retina Consultants of Austin) (2016-2018), Mathew MacCumber, MD, PhD (Rush University Medical Center) (2018-2020), Andrew N. Antoszyk, MD (Charlotte Eye Ear Nose & Throat Associates, PA) (2013-2016, 2020-2020), Judy Kim, MD (Medical College of Wisconsin) (2015-2017), John A. Wells III, MD (Palmetto Retina Center) (2013-2015), and Sangeeta Bhargava, PhD (National Eye Institute/National Institutes of Health) (2016-current). Executive Committee: Andrew N. Antoszyk, MD (Charlotte Eye Ear Nose & Throat Associates, PA (2009; 2013-present), Roy W. Beck, MD, PhD (JCHR) (2002-present), Sangeeta Bhargava, PhD (National Eye Institute/National Institutes of Health) (2016-present), Barbara Blodi, MD (University of Wisconsin–Madison) (2014-present), Frederick L. Ferris III, MD (Ophthalmic Research Consultants) (2002-present), Adam R. Glassman, MS (JCHR) (2005-present), Glenn J. Jaffe, MD (Duke Reading Center) (2012-present), Lee M. Jampol, MD (Feinberg School of Medicine, Northwestern University) (2012-present), Chirag D. Jhaveri, MD (Retina Consultants of Austin) (2016-present), Judy E. Kim, MD (Medical College or Wisconsin) (2015-2017, 2020-present), Brandon Lujan, MD (Casey Eye Center) (2017-present), Mathew MacCumber, MD, PhD (Rush University Medical Center and Illinois Retina Associates, SC) (2018-present), Dennis M. Marcus, MD (Southeast Retina Center, PC) (2011-2012, 2018-present), Daniel F. Martin, MD (Cole Eye Institute at Cleveland Clinic) (2017-present), Raj K. Maturi, MD (Raj K Maturi, MD, PC) (2009-2011, 2013-present), and Jennifer K. Sun, MD, MPH (Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology) (2009-present). Prior members: Lloyd Paul Aiello, MD, PhD (Joslin Diabetes Center, Beetham Eye Institute, Harvard Medical School) (2002-2018; Chair 2002-2005), Carl W. Baker, MD (Paducah Retinal Center) (2009-2019), Neil M. Bressler, MD (Department of Ophthalmology, Johns Hopkins University School of Medicine) (2006-2019; Chair 2006-2008), Susan B. Bressler, MD (Wilmer Eye Institute) (2009-2019), Matthew D. Davis, MD (Medical College of Wisconsin) (2002-2017), Michael J. Elman, MD (Elman Retina Group, PA) (2006-2018; Chair 2009 and 2012), Jeffrey G. Gross, MD (Carolina Retina Center, PA) (2012-2017), Diana M. Holcomb, COA (Retina Associates of Kentucky) (2011-2012), Andreas K. Lauer, MD (Casey Eye Center) (2007-2008), Ashley A. McClain, BS, CRC (Charlotte Eye Ear Nose & Throat Associates, PA) (2013), and Brandi J. Perez (Loma Linda University Eye Institute) (2013). Data and Safety Monitoring Committee: Gary Abrams, MD (Kresge Eye Institute), Deborah R. Barnbaum, PhD (Kent State University), Harry Flynn, MD (Bascom Palmer Eye Institute), Kyle D. Rudser, PhD (University of Minnesota), Paul Sternberg Jr, MD (Vanderbilt Eye Institute), Sangeeta Bhargava, PhD (National Eye Institute/National Institutes of Health), Ruth S. Weinstock, MD, PhD (SUNY Upstate Medical University), Stephen Wisniewski, PhD (University of Pittsburgh), and Charles P. Wilkinson, MD (Greater Baltimore Medical Center) (2012-2018). Diabetic Retinopathy Clinical Research Network clinical sites that participated in this protocol: sites are listed in order by number of participants enrolled into the study. The number of participants enrolled is noted in parentheses preceded by the site location and the site name. Personnel are listed as (I) for Study Investigator, (C) for Coordinator, (V) for Visual Acuity Technician, and (P) for Photographer. Charlotte, North Carolina: Southeast Clinical Research Associates, LLC (32): Omar S. Punjabi, MD (I); David Browning, MD, PhD (I); John Bradley Allen, MD (I); Andrew N. Antoszyk, MD (I); Angela K. Price, MPH (C, V); Taylor S. Jones (C, V); Sherry L. Fredenberg (C, V); Christina J. Fleming, BS, CCRP (C, V); Brittany A Murphy, BA, COT (C, V); Courtney Mahr (C); Erica Breglio (V); Kaitlin T. McShea, MS (V); Christina Mutch (V); Angella K. Gentile (V); Kayla A Bratcher (V); Sarah A. Ennis (V); Uma M. Balasubramaniam (P); Carol A Shore (P); Lisa A. Jackson (P); Loraine M. Clark, COA (P); Lynn Watson (P); Michael D. McOwen (P); Shannon Stobbe (P); Donna McClain, COA (P); and Tracy A. Ross (P). Huntington Beach, California: Salehi Retina Institute Inc (23): Hani Salehi-Had, MD (I); Evelyn Ceja (C); Sara Ahmed, BS (C); Stephanie Ramirez (C, P, V); Scott F. Lee, OD (V); Mary Ma, OD (V); Mailan Tran, OD (V); Undariya Boldbaatar (P); Nikki Nguyen, BS (P); Lily Castillo (P); Janet Reyes (P); and Karen Gasperian (P). Hagerstown, Maryland: Mid Atlantic Retina Specialists (16): Adam T. Gerstenblith, MD (I); Robert E. Parnes, MD (I); April L. Stockman (C, P, V); Jennifer Shirey (V); Kylie Stambaugh (V); Angie Goldizen (P); Leslie Toomey (P); and Lora Glaspell (P). Houston, Texas: Retina Consultants of Texas, PA (13): Charles C. Wykoff, MD, PhD (I); Rosa Y. Kim, MD (I); Tien P. Wong, MD (I); James C. Major, MD (I); Matthew S. Benz, MD (I); David M. Brown, MD (I); Richard H. Fish, MD (I); Eric Chen, MD (I); Ankoor R. Shah, MD (I); Amy C. Schefler, MD (I); Tyneisha McCoy (C); Jose Munoz (C); Sadia Y Karani (C); Stacy M. Supapo (C); Garret L Twining (C); Diana Rodriguez (C); Maura A Estes (C); Daniel Park (C); Amy Hutson (C); Calley N. Smith (C); Danee Foerster (C); Lindsay Burt (V); Melina Vela (V); Miguel Oviedo (V); Ilsa Ortega (V); Heather Koger-Grifaldo (V); Nina A. Webb (V); Veronica A. Sneed (V); Lisa M Wolff (V); Elizabeth Quellar (V); Belinda A. Almanza (V); Rebecca Yee (V); Eric N. Kegley (P); Miranda F James (P); Cary A. Stoever (P); Beau A Richter (P); David Garcia (P); and Luis R. Salinas (P). Santa Barbara, California: California Retina Consultants (13): Dante J. Pieramici, MD (I); Alessandro A. Castellarin, MD (I); Daniel L. Learned, MD (I); Nathan Steinle, MD (I); Dilsher Dhoot, MD (I); Carmen Carbajal (C); Libby Dahlberg (C); Gina Hong, BS, BA (C, P, V); Marco A Munoz (C, V); Jack Giust, BS (C, P); Jamison C Ray, BS (C, V); John McDermott (C, V); Kate M McKee, BS (C, P, V); Kevin Card (C, V); Kelly Avery (V); Laura Budvytyte (V); Jerry Smith (V); Nancy Castillo (P); Aimee H. Shook, BS (P); and Susan Spaeth (P). Augusta, Georgia: Southeast Retina Center, PC (12): Dennis M. Marcus, MD (I); Harinderjit Singh, MD (I); Siobhan O. Ortiz (C); Amina Farooq, MD (C); Thomas Bailey (V); Lindsay Allison Foster (V); Michele Woodward (V); and Ken Ivey, COA (P). Oakland, California: East Bay Retina Consultants Inc (12): Soraya Rofagha, MD, MPH (I); Jesse J. Jung, MD (I); Eugene Stephen Lit, MD (I); Heidi A. Winje (C, P); Maria Zamora (C); Renjini Balakrishnan, MSc (C); Caroline Frambach (V); Denise Joy Bustamante (V); Joshua R Machacon (V); Mae Kwan (V); Helen Ricks (V); Afsoon Jamali (P); and Maria Miranda (P). Indianapolis, Indiana: Raj K. Maturi, MD, PC (10): Raj K. Maturi, MD (I); David A. Lightman, MD (I); Stephen J Saxe (I); Lorraine White (C, P, V); Ashley M. Harless (C, P, V); Carolee K. Novak, CRC (V); Erin Brown (V); Myra K Retrum (V); Thomas Steele, CRA (P); Holly Fiscus (P); Yesenia Sarmiento (P); Stephanie J. Morrow, COA (P); and Charlotte Harris (P). Paducah, Kentucky: The Ophthalmology Group LLC (10): Carl W. Baker, MD (I); Ron H. Tilford, MD (I); Jil D Baker, MT, ASCP (C); Tracey M. Caldwell, CCRC (C); Margaret J. Orr, COA (V); Mary J. Sharp, COA (V); Samantha Kettler (P); Sonya L Alcaraz (P); Kylie S. Sedberry (P); and Alecia B. Camp (P). Austin, Texas: Retina Research Center (8): Brian B. Berger, MD (I); Chirag D. Jhaveri, MD (I); Saradha Chexal, MD (I); Gowtham Jonna, MD (I); Daniela Vega Pereira (C); Daniela Mariel Wilson (C); Tina A Seidu (C); Ivana Gunderson (C, V); Ryan M. Reid (C, P); Valerie Gatavaski (V); Abla M Harara (V); Boris Corak, BS (P); Yong Ren (P); and Christopher C. Stovall (P). Austin, Texas: Austin Retina Associates (8): Robert W. Wong, MD (I); Jose A. Martinez, MD (I); Peter A. Nixon, MD (I); Margaret A. Rodriguez, COA (C); Phillip V. Le (C, P, V); Corinne C Vargas (C, P, V); Gopal Karsaliya (C, P, V); Chris A. Montesclaros (C, P); and Cory Mangham (P). Boston, Massachusetts: Joslin Diabetes Center (8): Lloyd Paul Aiello, MD, PhD (I); Miin Irene Roh, MD, PhD (I); Sabera T. Shah, MD (I); Jennifer K. Sun, MD, MPH (I); Paolo S. Silva, MD (I); George S. Sharuk, MD (I); Paul G. Arrigg, MD (I); Margaret E. Stockman (C, V); Jae W Rhee (C); Tanya Olesker, BS (C); Leila Bestourous (V); Mina Sehizadeh, OD (V); Jerry D. Cavallerano, OD, PhD (V); William Carli, COA (V); Steve L. Papaconstantinou, COT (V); Elizabeth S. Weimann, COT, BS (V); Michael N. Krigman (V); Robert W. Cavicchi (P); and Konstantina Sampani (P). Knoxville, Tennessee: Southeastern Retina Associates, PC (8): Joseph M. Googe, MD (I); R. Keith Shuler, MD (I); Nicholas G. Anderson, MD (I); Kristina Oliver (C); Steve Morris (C); Vicky L. Seitz (C); Julie Asher (C, V); Summer McCoy (V); Katie Milstead (V); Jeff Wheeler (V); Caitlin Gilbreath (P); Justin Walsh (P); Raul E. Lince (P); Hodge A. Griffone (P); and Sarah M. Oelrich (P). Marietta, Georgia: Marietta Eye Clinic (8): Annal Dhanu Meleth, MD, MS (I); Lakshmana Murthy Kooragayala, MD (I); Chigozie Nkemka (C); Chenavia Lewis, MS, CCRP (C, P, V); Meuzette White-Walker (C); Minuette S Jackson, BA, COA (C, V); Shakirah J Sewell (C); Samantha Sircar (P); Adam Goff (P); and Kenneth Thompson (P). Loma Linda, California: Loma Linda University (7): Joseph T. Fan, MD (I); Kakarla V. Chalam, MD (I); Samuel C. Kim, MD (I); Michael E. Rauser, MD (I); David Isaiah Sierpina, MD (I); Tina L Ramirez (C); Vivian L Garcia (C); Raquel Hernandez (C, V); Anthoni Tampubolon (C, P, V); Jayson S Paw (C); Jacqueline V Midgett, MPH (C); Marcia Easterly (P); Adel E Alset, COA (P); and Moises Tellez (P). North York, Toronto, Ontario: Chow Berger Koushan Medicine Professional Corporation o/a Toronto Retina Institute (7): Keyvan Koushan, MD, FRCSC (I); Myuri Jeyabalachandran (C); Pauline Fung (C); Arman Amiri (C); Stephanie Hegarty (V); Parita Thakker (P); Jennifer Wong (P); Devjani Dutta (P); and Gloria Leung (P). Toronto, Ontario: University Health Network (7): Michael Henry Brent, MD, FRCSC (I); Efrem D. Mandelcorn, MD, FRCSC (I); Olivera Sutakovic, MD, CCRCII (C, P, V); Michelle Moon (C, P, V); Lindsay Hampton-Hampejskova (C, P); Lina Chen (C, P, V); Bilgin Turhal, MD (C, P, V); Claire Mowatt (P); Susan Bolychuk (P); Ian Brown (P); and Isaac A Kotei (P). Ayer, Massachusetts: Valley Eye Physicians and Surgeons (6): Gisela Velez, MD, MPH, MA (I); Oksana Mykhaylyk (C, V); Madeline Leon (C, P); Elizabeth I. Johnson, MS (C); Maa Ahema Parry, OD, MEd (C); Travis Sweeney (C); Nicholas Chang (V); Nicholas R Mastrodomenico (V); Michael D. Ortega, CMA (P); Amanda Aho (P); Jean Larkin (P); Jhan Carlos Caro (P); Christine Manuel (P); Joseph A. Myers (P); Beatriz LaFountain (P); Crystal Girard (P); Armando Saez (P); Chandapilla C. Pallipeedikayil (P); and Thomas Taylor (P). Houston, Texas: Baylor College of Medicine, Baylor Eye Physicians and Surgeons (6): Christina Y. Weng, MD, MBA (I); Tahira Scholle, MD (I); Laura A Baker (C, V); Becky R. Chatham (C, V); Wendy Blacutt, MD (C, V); Jiping Cai, MD (C, V); Annika S. Joshi, COA, CCRC (C, V); April Leger, COT (V); Joseph F. Morales (P); and Dana B. Barnett (P). Orlando, Florida: Florida Retina Institute, James A. Staman, MD, PA (6): Matthew A. Cunningham, MD (I); Elias C. Mavrofrides, MD (I); Jaya B. Kumar, MD (I); Samuel K. S. Houston, III, MD (I); Elaine Rodriguez-Roman, OD (C); Alma Rodriguez (P); Chanell Thomas (P); Dianelis Figueroa (P); Francisco Pineda (P); and Timothy S Holle (P). Baltimore, Maryland: Elman Retina Group, PA (5): Michael J. Elman, MD (I); Henry A. Leder, MD (I); JoAnn Starr (C); Twyla J Robinson (C); Travis J. Smalls, BA, MS (C); Kate N Kreis (C); Jennifer L. Belz (C); Alesia K McCalla (V); Christine Ringrose (V); Teresa Coffey (V); Perel M. Simpson, COA (V); Pamela V. Singletary, COA (V); Katherine L Wentz (V); Amy Thompson (V); Dallas R. Sandler (V); Ashley M. Metzger (P); Peter Sotirakos (P); and Terri Cain (P). Eugene, Oregon: Sterling Vision DBA Oregon Retina (5): Albert O. Edwards, MD, PhD (I); Allan A. Hunter III, MD (I); Jessica Zuniga (C, V); Jonathan Wallace (C, V); Natalie W. Kogutkiewicz (C, V); Nicole M Gregorich (C, V); Ryan G. Lebien, BS (C, P, V); Nicole Muhlnickel (V); and Andrew G. Everett (P). New York, New York: Macula Care (5): Daniel F. Rosberger, MD, PhD, MPH (I); Nneka O. Brooks, MD (I); Phuntsho Wangmo, BA (C); Mohammed Yaseen (C, P, V); Sandra Acevedo, BS (C, V); Sarah Bendarkawi, BS (C); Joshua A Pickell, BA (C); Sonam Gyaltshen (P); and Yenelda M. Gomez (P). Philadelphia, Pennsylvania: The Trustees of the University of Pennsylvania (5): Alexander J. Brucker, MD (I); Sheri Drossner, MSW (C, V); Joan C. DuPont, CRC (C, V); Devica L Bhutani (V); Kennedy N Johnson (V); Judy Chen (P); Jim M. Berger (P); Cheryl Devine (P); and Sara Freeman (P). Phoenix, Arizona: Arizona Retina and Vitreous Consultants and Doc Trials, LLC (5): Shabari S. Seetharam, MD (I); Anita Prasad, MD (I); Ramin Schadlu, MD (I); Brigid Smith, BS (C); Lindsey Butler, BSN (C); Juan Tonche (P); and Jacob Michael Hylands (P). Sandy Springs, Georgia: Thomas Eye Group (5): Paul L. Kaufman, MD (I); Jessica D. McCluskey, MD (I); Kathy T. Wynne, BS, COT (C, V); Cynthia Weaver, COT (V); Rosario Romero (P); Brandun Watson, BS, COT (P); Kristin Gilbert (P); Carlos R. Cook (P); and Sarah Matloff, COA (P). Chattanooga, Tennessee: Southeastern Retina Associates (4): Richard I. Breazeale, MD (I); Francis C. DeCroos, MD (I); Devon Ghodasra, MD (I); Rohan J. Shah, MD (I); Steve W. McBee, Jr. (C); Elizabeth Lisa McDonald (C, P); Courtney Duncan (V); Brianna J Lewis (V); Kate Menefee (V); David Woods, CRA, COA, CST (P); and Roger P. Melendrez (P). Sacramento, California: Regents of the University of California, Davis, DBA University of California, Davis (4): Ala Moshiri, MD, PhD (I); Glenn C. Yiu, MD, PhD (I); Cynthia Wallace (C); Denise C Macias (C); Angela M. Beliveau (C); Susan Garcia (V); Marisa E. Salvador (V); Karishma Chandra (P); Sashi Deo (P); John Peterson (P); and Igor Slabosnitskiy (P). Chapel Hill, North Carolina: University of North Carolina at Chapel Hill (3): Jan Niklas Ulrich, MD (I); Seema Garg, MD, PhD (I); Cassandra J. Barnhart, MPH (C); Elizabeth L. DuBose, MPH (C, V); Kanika A Bhansali (C, V); Debra Cantrell (P); Veronica Jones (P); Rona Lyn Esquejo (P); Sean Grout (P); and Houston P Sharpe (P). Columbia, South Carolina: Carolina Retina Center (3): Jeffrey G. Gross, MD (I); Victor A. Neamtu, MD (I); Joel Gross (C); Vincent Klapper (C, V); Amy M. Flowers, BA (C, V); Angelique SA McDowell, BS (V); and Randall L. Price, BA (P). Fort Myers, Florida: National Ophthalmic Research Institute (3): A. Thomas Ghuman, MD (I); Paul A. Raskauskas, MD (I); Ashish G. Sharma, MD (I); Joseph P. Walker, MD (I); Kristi Maro (C); Cheryl Kiesel, COA, ROUB (C); Eileen Knips, RN, COA, CRA (C, P); Cheryl Ryan (C); Crystal Y. Peters, CCRC (C); Anita H. Leslie (V); and Raymond K. Kiesel (P). Lakeland, Florida: Florida Retina Consultants (3): Nader Moinfar, MD, MPH (I); Scott M. Friedman, MD (I); Shannon M Rehling (C, V); Damanda F. Fagan (C, P, V); Kimberly A. Williamson (C); Ceara L Wendel (C); Jacqueline Andrews (V); Karen Seyez, COT (V); Shana E Williams (P); Allen McKinney (P); and Brenda J. Bobbitt (P). McAllen, Texas: Valley Retina Institute (3): Victor Hugo Gonzalez, MD (I); Nehal R. Patel, MD (I); Rohit Adyanthaya, MD (I); Yesenia Salinas, CRC (C); David A. Reyes, BS (C); Nancy L Salinas (C); Angelina Garza, BS (C); Ana L Pina, BA (C); Amber B Ibarra, BS (C); Elyssa Navarro (C); Janette Arredondo (V); Isaac Cabrera (V); Rebecca R. Flores, COA (V); Yvonne Diaz (V); Brenda Velasquez (V); Enrique Chavez (V); Monica R. Cantu, COT (V); Monique Montemayor, COA (P); Stephanie Tamez (P); Santos Garza (P); and Samuel Alonso (P). Miami, Florida: University of Miami (3): Justin H. Townsend, MD (I); Jessica Taha (C); Belen Rodriguez, CCRP (C); Ailen E Gutierrez, BA (C); Alexey Gomez Rodriguez (V); Enelda Idalia Mendoza (V); Liliana P. Perez (V); Megan Mawdesley (P); Ailen Graces Fernandez (P); Tanya Nicole Rego (P); Shannon B Asklar (P); and Brandon Michael Sparling (P). Portland, Oregon: Oregon Health & Science University (3): J. Peter Campbell, MD, MPH (I); Andreas K. Lauer, MD (I); Christina J Flaxel, MD (I); Steven T. Bailey, MD (I); Thomas S. Hwang, MD (I); Mitchell Schain, BS (C, P, V); Ann D. Lundquist, BA (C, V); Jennifer K Maykoski, BS (V); Shirley D. Ira, COT (V); Chris S Howell, BA (P); Dawn M. Ryan, CRA (P); Jocelyn T. Hui, BS (P); Jordan Barth, AA (P); Chiedozie Ukachukwu (P); and Scott R. Pickell, BS (P). Syracuse, New York: Retina-Vitreous Surgeons of Central NY, PC (3): Jamin S. Brown, MD (I); G. Robert Hampton, MD (I); Laurie J. Sienkiewycz (C); Christine M. Dorr (C); Lisa Spuches (V); Lynn M. Kwasniewski (V); Michelle L. Manley (V); Abigail Miller (P); Nicole E. Robarge (P); Stefanie R. DeSantis, BS (P); Teresa M. DeForge (P); and Jeffrey P Barker (P). West Monroe, Louisiana: Joseph E. Humble and Raymond Haik PTRS DBA Eye Center Eye Assoc of Northeast Louisiana (3): Ruben A. Grigorian, MD (I); Latha M Jois (C, P); Rebecca Morris (C, P, V); Rebecca Webb, BS, CRC (C, P, V); Dusti D Douglas (V); Sharoon David, MBBS (P); and Faith Pena, BS (P). Asheville, North Carolina: Western Carolina Clinical Research, LLC (2): Cameron McLure Stone, MD (I); McCayla Elise Hall (C); Andrea K. Menzel, COA (C); Monica Hamrick (C); Lea R. Raymer, BS (C); Leslie D. Rickman, COA (V); Julia Crokett Overbey (V); Donna Machen (V); Lisa H. Hawkins, COA (P); Melissa Smith (P); and Paula A. Price, COT (P). Halifax, Nova Scotia: Nova Scotia Health Authority (2): Alan F. Cruess, MD (I); R. Rishi Gupta, MD, DABO (I); John D. Dickinson, MD (I); Alec M. Cranston (C); Meggie D. Caldwell (C); Stacey Durling (V); Mitzi Hynes, COT (P); and Trina MacDonnell, OC (C), COMT (P). Lubbock, Texas: Texas Retina Associates (2): Michel Shami, MD (I); Yolanda Saldivar (C); Ashaki Meeks (V); and Glenn R. Gardner, CRA (P). Monroeville, Pennsylvania: Retina-Vitreous Consultants, Inc. (2): Karl R. Olsen, MD (I); Jared E. Knickelbein, MD, PhD (I); Robert L. Bergren, MD (I); Bernard H. Doft, MD (I); Lori A. Merlotti (C); Julie Walter (V); Lois Stepansky (V); Dawn Diperna (P); and Phyllis P Ostroska (P). Palm Desert, California: Southern California Desert Retina Consultants, Inc (2): Clement K. Chan, MD (I); Maziar Lalezary, MD (I); Tiana Gonzales (C); Kimberly S. Walther (C); Tonya M Gieser (C); Isela Aldana (C, V); Lenise E. Myers, COA (V); Kristina Pettit (P); and Kenneth M. Huff, COA (P). Pinellas Park, Florida: Southeast Eye Institute, P.A. dba–Eye Associates of Pinellas (2): Jason M. Handza, DO (I); Bronson Oudshoff, CCRC (C); Corey T. McGahee, COA (P); Christina Glover (P); nd Annette M. Carey, COA (P). Plantation, Florida: Eye Physicians of Florida LLC DBA Fort Lauderdale Eye Institute LLC (2): Tirso M. Lara, MD (I); Stuart K. Burgess, MD (I); Noel H. Pereda, MD (C, V); Deborah Davis (V); Adriana Villa (V); Mark Oberlander (P); and Karen Workman (P). Portland, Oregon: Retina Northwest, PC (2): Apurva K. Patel, MD (I); Paul S. Tlucek, MD (I); Mark A. Peters, MD (I); Colin Ma, MD (I); Brian S Puckett (C); Pualani Smith (C); Stephanie L. Ho, BA (C, P, V); Margaret E Charpentier (V); Marcia Kopfer, BS, COT (V); and Christine Hoerner (P). Sarasota, Florida: Sarasota Retina Institute (2): Melvin Chen, MD (I); Peggy A. Jelemensky (C, V); Samantha R. Basham (V); Tara L. Raphael (V); Mark Sneath, COA (P); and Rosa Miller (P). Shawnee Mission, Kansas: Retina Associates, PA (2): Gregory M. Fox, MD (I); Ryan D. Christensen, MD (I); David S. Dyer, MD (I); Ivan R. Batlle, MD (I); Ravi S. J. Singh, MD (I); Lexie R. Ainley (C); Karla A. Batlle, BS (C); Amber R. VandeVelde, RN (V); Holly Wyrick (V); Frank T. Yeager (P); and Katherine Pippin (P). Southlake, Texas: Jawad A. Qureshi MD, PA DBA Retina Center of Texas (2): Jawad A. Qureshi, MD (I); Kruti P. Dajee, MD (I); Johnathan D. Warminski, MD (I); Pualani Smith (C, V); Victoria E. Cowart (C); Andre Watkins (P); Denise Ortiz (P); and Diana Murillo (P). Vancouver, British Columbia: University of British Columbia and Vancouver Coastal Health Authority and Eduardo Navajas, MD, PhD (2): Eduardo Vitor Navajas, MD, PhD (I); Sijia Cao (C); Mira Jovanovic, Msci (C, V); Theresa Wiens, MSc, CCRP (C); Sherry Han, MSc (V); Bryan Harrison (P); Anne-Marie Godfrey (P); and Kelly Grant (P). Baltimore, Maryland: Johns Hopkins University (1): Sharon D. Solomon, MD (I); Susan Bressler, MD (I); Deborah Donohue (C, V); Lisa K. Levin (C); Mary Frey, BSc, CCRP (V); Russ Distle (P); and Dennis Cain, CRA (P). Chicago, Illinois: Northwestern University (1): Alice T. Lyon, MD (I); Manjot K. Gill, MD (I); Chisomo Mwale (C, V); Carmen Ramirez (C, V); Crystal Santillanes (C, V); Evan C. Davies (C); Nicole M Seddon (C); Priya M Thakkar, BS (C); Anson Moore (V); Cason Moore (P); Maritza Barragan (P); and Evica Simjanoski, BFA (P). Chicago, Illinois: The Board of Trustees of the University of Illinois (1): Jennifer I. Lim, MD (I); Felix Y. Chau, MD (I); Jie Sun, MD (C); Tametha Johnson (V); Natasa Stankovic, AAS, COT (V); Ben Martinez (V); Mark Janowicz, BS (P); and Andrea Degillio, CRA, CDOS (P). Jacksonville, Florida: University of Florida–Jacksonville (1): Sandeep Grover, MD (I); Ghulam Shabbir Hamdani, MBBS, MSH, CCRP (C); Bharani Krishna Mynampati A, PhD (C, P, V); Romesh Babaria, MS (C, V); and Jazzmin N Smith (C, P). Madison, Wisconsin: The Board of Regents of the University of Wisconsin System (1): Justin Gottlieb, MD (I); Barbara A. Blodi, MD (I); Kristine A. Dietzman, BS, CCRC (C); Christopher M. Smith, COA (C, V); Angela M. Adler, BS, CCRC (V); Denise A. Krolnik, MS (P); and Sandie L. Reed, AD (P). Minneapolis, Minnesota: Retina Center, PA DBA Retina Center of Minnesota (1): Abdhish R. Bhavsar, MD (I); Andrea Gilchrist (C); Matt D. Peloquin, AA (V); Jason R Sweet (V); Denise Vang (P); Erin C. Kinney (P); and Alanna C. Evans (P). New York, New York: The New York Eye and Ear Infirmary (1): Ronald C Gentile, MD (I); Melissa Rivas (C, V); John Bo Soo Choi (C, V); Wanda Carrasquillo-Boyd (P); and Robert Masini (P). Orlando, Florida: Magruder Eye Institute (1): John T. Lehr, MD (I); Brittany M. Pendarvis (C); Elaine Rodriguez-Roman, OD (C); Mari Delgado (C, P, V); Atira Bramble, COA (V); Robert Atnip (V); Patricia Lynch (V); Martha Eileen Haddox (V); Julian Rodriguez (P); Kyle Dreessen (P); Ashley E Willer (P); Mark Pena (P); and Chase Hutchings, COA (P). Overland Park, Kansas: Mid-America Retina Consultants, PA (1): William N. Rosenthal, MD (I); Elizabeth N. Heim, BSN, RN (C); Sarah N. Lamaster, RN, BSN (C, V); Courtney J. Dunn (P); R. Scott Varner (P); and Mary C. Stewart, RN (P). San Antonio, Texas: Retinal Consultants of San Antonio (1): Moises A. Chica, MD (I); Calvin E. Mein, MD (I); Lydia Adams (C); Jenny M Bermea (C); Sara L Cloudt (C); Lita Kirschbaum, COA (C); Victoria Lopez (V); Jonathan San Roman (V); Samantha Bankston (P); Brenda Nakoski (P); and Christopher Sean Wienecke (P). Springfield, Illinois: Springfield Clinic, LLP (1): Ramanath Bhandari, MD (I); Jennifer Shaw (C, P); Bradley C. Evans, LPN, COA (C); Braden Anderson (V); Gaylan W Moushon, OD (V); Kris Karrick, COA (P); Caitlyn Wessel (P); and Dennis Frye (P). Trumbull, Connecticut: New England Retina Associates, PC (1): Gregory M. Haffner, MD (I); Andrea L. DeClement (C); Leslie D. Hurst, MS (C); Patricia L Anderson (C); Adriana N. Enxuto (V); Stephanie Esteves (V); and Emily Morse, BS (P). Tucson, Arizona: University of Arizona Medical Center/Department of Ophthalmology (1): John B. Christoforidis, MD (I); Jill Brickman-Kelleher, BS, AAS (C); Sue A. Bulau (C, V); Patricia H. Fryer (V); and Dennis Haymore (P). West Columbia, South Carolina: John A. Wells, III MD DBA Palmetto Retina Center, LLC (1): John A. Wells, III, MD (I); Tiffany R. Swinford (C, V); Tiffany N. Ogbuewu (V); Robbin Spivey (P); and Ashley Studebaker (P). West Des Moines, Iowa: Wolfe Eye Clinic, PC (1): Jared S. Nielsen, MD (I); Kyle J. Alliman, MD (I); Tami Jo Woehl (C); Marianne Parker (C); Erin L. Riley (C); Jack Bowers (V); Jamie Spillman (V); Paula L. Bix (V); Spencer D. Ridgway (P); and Lisa M. Boender (P).

Data Sharing Statement: See Supplement 3.

Additional Information: The data collected for this study, including deidentified participant data and a data dictionary defining each filed in the data set, will be made available at https://public.jaeb.org/drcrnet/stdy no later than 12 months after publication of the final 4-year primary results. At that time, the data will be made available to anyone requesting the data.

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