Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease
Completed · Phase 2, Phase 3 · NCT04429503
Conditions: Diabetic Macular Edema, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
At a glance
- Research payments reported, 2025
- $4.2M
- U.S. investigators named
- 86
- Sites paid
- 81
- Planned or actual enrollment
- 660
About the trial
- Sponsor
- Regeneron Pharmaceuticals (with Bayer)
- Tested
- aflibercept (drug), High-dose aflibercept (drug)
- Dates
- Started 2020-06-29; completion 2024-06-18
- Results posted
- Yes
The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks. The secondary objectives of the study are as follows: * To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response * To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept
From ClinicalTrials.gov, last updated 2025-08-08. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Regeneron Pharmaceuticals, Inc. reported $4.2M in research payments for this study in 2025 (11,532 payments).
Products named: Eylea Hd
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Ramin Schadlu, MD Ophthalmology · Phoenix, AZ
- Payam Amini, M.D Retina Specialist · Pasadena, CA
- Nika Bagheri, M.D. Retina Specialist · Simi Valley, CA
- Hajir Dadgostar, MD Ophthalmology · Encino, CA
- Amr L. Dessouki, MD Ophthalmology · Campbell, CA
- Diana V. Do, MD Retina Specialist · Stanford, CA
- Julie L. Gasperini, M.D. Ophthalmology · Long Beach, CA
- Liliya Golas, MD Ophthalmology · Rancho Cordova, CA
- Vivienne S. Hau, M.D., PH.D. Ophthalmology · Riverside, CA
- Atul K. Jain, M.D. Ophthalmology · San Diego, CA
- Ash Pirouz, MD Retina Specialist · Fullerton, CA
- Pradeep S. Prasad, M.D. Ophthalmology · Los Angeles, CA
- Richard H. Roe, M.D. Ophthalmology · Los Angeles, CA
- Hani Salehi-had, M.D. Retina Specialist · Huntington Beach, CA
- Peter H. Win, MD Ophthalmology · Arcadia, CA
- Moss J. Fenberg, MD Retina Specialist · Durango, CO
- Curtis L. Hagedorn, M.D. Ophthalmology · Denver, CO
- James K. Luu, M.D. Retina Specialist · Colorado Springs, CO
- Nauman Chaudhry, M.D. Retina Specialist · Waterford, CT
- Adam S. Berger, MD Ophthalmology · Winter Haven, FL
- Stuart K. Burgess, M.D. Retina Specialist · Plantation, FL
- Matthew A. Cunningham, MD Ophthalmology · Orlando, FL
- Dana M. Deupree, MD Retina Specialist · Hudson, FL
- David A. Eichenbaum, M.D. Ophthalmology · St Petersburg, FL
- Ronald E. Frenkel, M.D. Ophthalmology · Stuart, FL
- Scott M. Friedman, M.D. Ophthalmology · Lakeland, FL
- Richard J. Hairston, MD Ophthalmology · Largo, FL
- Jason M. Handza, D.O Retina Specialist · Pinellas Park, FL
- Vrinda S. Hershberger, MD Retina Specialist · Melbourne, FL
- Wilfredo C. Lara, MD Ophthalmology · Miami, FL
- Ashish G. Sharma, MD Retina Specialist · Fort Myers, FL
- Benjamin J. Thomas, MD Ophthalmology · Jacksonville, FL
- Eduardo Uchiyama, M.D. Retina Specialist · Ft Lauderdale, FL
- Sunir Joshi, M.D. Ophthalmology · Lithonia, GA
- Dennis M. Marcus, M.D. Ophthalmology · Augusta, GA
- Annal D. Meleth, M.D, M.S Ophthalmology · Marietta, GA
- Robert A. Stoltz, MD Specialist · Marietta, GA
- Raymond Wee, MD Ophthalmology · Aiea, HI
- Ramanath Bhandari, MD Ophthalmology · Springfield, IL
- Veeral Sheth, M.D. Ophthalmology · Oak Forest, IL
- Mohamed G. Gendy, M.D. Ophthalmology · Fort Wayne, IN
- Milan Shah, M.D. Retina Specialist · Carmel, IN
- Ivan R. Batlle, MD Ophthalmology · Lenexa, KS
- Jeffrey S. Heier Retina Specialist · Boston, MA
- Adam T. Gerstenblith, MD Retina Specialist · Hagerstown, MD
- Eric P. Suan, M.D. Ophthalmology · Baltimore, MD
- Antonio Capone JR., MD Retina Specialist · Royal Oak, MI
- Jorge I. Calzada, M.D. Retina Specialist · Southaven, MS
- William Z. Bridges JR., M.D. Retina Specialist · Asheville, NC
- Omar S. Punjabi, M.D. Ophthalmology · Charlotte, NC
- Patrick M. Higgins, MD Ophthalmology · Bloomfield, NJ
- Sumit P. Shah, M.D. Retina Specialist · New Brunswick, NJ
- Judy C. Liu, MD Ophthalmology · Henderson, NV
- Jamin S. Brown, M.D. Retina Specialist · Liverpool, NY
- Philip J. Ferrone, MD Ophthalmology · Great Neck, NY
- Paul Hahn, MD Retina Specialist · Nanuet, NY
- Ketan Laud, M.D. Ophthalmology · Massapequa, NY
- Pamela A. Weber Ophthalmology · Shirley, NY
- Christopher J. Devine, M.D. Ophthalmology · Cincinnati, OH
- James Osher, M.D. Ophthalmology · Blue Ash, OH
- Sugat S. Patel, MD Retina Specialist · Dublin, OH
- Llewelyn J. Rao, MD Retina Specialist · Beachwood, OH
- Lawrence J. Singerman, M.D. Ophthalmology · Beachwood, OH
- Justin Parschauer, D.O. Ophthalmology · Tulsa, OK
- Sandeep N. Shah, MD Retina Specialist · Edmond, OK
- Christopher M. Aderman, M.D. Retina Specialist · Troutdale, OR
- Paul W. Conrad, MD PHD Ophthalmology · Monroeville, PA
- Erik F. Kruger, MD Ophthalmology · Kingston, PA
- Yoshihiro Yonekawa, M.D. Ophthalmology · Plymouth Meeting, PA
- Andres Emanuelli Anzalotta, M.D. Ophthalmology · Arecibo, PR
- Daniel Alfaro III, M.D. Ophthalmology · Charleston, SC
- William L. Clark, MD Ophthalmology · West Columbia, SC
- Eric Jablon, M.D. Ophthalmology · Charleston, SC
- Prema Abraham, MD Retina Specialist · Rapid City, SD
- Steve T. Charles, M.D. Retina Specialist · Germantown, TN
- Ailee M. Laham, M.D. Retina Specialist · Knoxville, TN
- Eric W. Schneider, MD Retina Specialist · Nashville, TN
- David Brown, M.D. Ophthalmology · Houston, TX
- Seong Y. Lee, MD Ophthalmology · Abilene, TX
- Calvin E. Mein, M.D. Ophthalmology · San Antonio, TX
- Sunil S. Patel, MD, PHD Ophthalmology · Abilene, TX
- Charles C. Wykoff, MD, PHD Ophthalmology · Bellaire, TX
- Mitchell J. Goff, M.D. Retina Specialist · Salt Lake City, UT
- Jordana G. Fein, M.D., M.S. Retina Specialist · Fairfax, VA
- Kapil G. Kapoor, MD Ophthalmology · Norfolk, VA
- Ghassan R. Ghorayeb, MD Ophthalmology · Clarksburg, WV
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Pinnacle Research Institute Inc $226,378
- Salehi Retina Institute $185,798
- Charleston Neuroscience Institute LLC $182,089
- East Florida Eye Institute $165,217
- University Retina and Macula Associates PC $160,135
- Mid Atlantic Retina Specialists $154,839
- The Retina PArtners $144,561
- California Eye Specialists Medical Group Inc $139,440
- Emanuelli Research and Development Center LLC $132,920
- Florida Retina Institute $120,122
- Retina Consultants of Texas $118,644
- Tennessee Retina PC $117,175
- Tulsa Retina Consultants PLLC $101,273
- Ophthalmic Consultants of Boston $89,236
- Retina Consultants of Hawaii Research Account $89,213
- Blue Ocean Clinical Research Center LLC $83,164
- Retina Group of New England PC $80,673
- Pautler Cohen Findlay and Eichenbaum MDs PA $79,051
- Retina Vitreous Center PLLC $71,811
- Eyehealth Northwest PC $62,531
- Carson Mcbeath and Boswell Inc $60,713
- Black Hills Regional Eye Institute LLP $59,745
- Long Island Vitreoretinal Consultants $58,446
- Florida Eye Associates Inc $57,969
- Retina Vitreous Associates Medical Group $56,476
- Southeast Retina Center PC $54,638
- $53,199
- Prairie Eye Center LTD $52,201
- Florida Retina Consultants $51,015
- Joseph R Martel MD Inc $50,705
- Strategic Clinical Research Group LLC $48,497
- Ophthalmic Consultants of Long Island $48,462
- American Institute of Research $47,685
- Retina Associates of Cleveland Inc $44,626
- Deep Blue Retina Clinical Research PLLC $42,317
- Envision Ocular LLC $41,888
- Eye Associates of Pinellas $37,834
- Vitreous and Retina Consultants PA $36,385
- Retina Vitreous Surgeons of Central Ny PC $35,201
- Southern California Permanente Medical Group $33,738
- Cincinnati Eye Institute $33,297
- Win Retina $32,988
- Total Practice Management $32,655
- Fort Wayne Retina P C $31,554
- Pamela A Weber MD PC $31,013
- Georgia Retina P C $30,481
- Retina Macula Specialists of Miami LLC $29,927
- Midwest Retina Inc $29,859
- Charlotte Eye Ear Nose and Throat Associates PA $29,807
- Southeastern Retina Associates PC $29,705
- National Ophthalmic Research Institute $28,990
- Springfield Clinic LLP $28,361
- Retina Consultants San Diego Inc $25,466
- Retina Consultants of Nevada $21,908
- Retina Consultants of Southern Colorado PC $18,944
- Southwest Retina Research Center $18,438
- Mid Atlantic Retina $17,943
- Retina Vitreous Consultants LLP $17,853
- Retina Associates PA $16,528
- Meridian Clinical Research Llc-Omaha $14,691
- Retina Consultants of Orange County Inc $13,832
- Associated Retinal Consultants PC $13,651
- Coloradoretinaassociatespc $13,042
- Retinal Consultants of San Antonio PA $12,760
- Charles Retina Institute PC $12,667
- Arizona Retina and Vitreous Research $12,095
- Palmetto Retina Center LLC $11,734
- Eye Care Specialists PC $11,440
- West Virginia University $10,960
- Wagner Macula and Retina Center $10,412
- Eye Institute of West Florida $10,374
- Marietta Eye Clinic $10,096
- Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center $10,071
- Rocky Mountain Retina Consultants $9,718
- Fort Lauderdale Eye Institute LLC $8,715
- Colorado Retina Associates PC $7,238
- Retina Research Institute of Texas $6,874
- Western Carolina Clinical Research LLC $6,746
- Retina Vitreous Consultants $5,517
- California Retina Consultants $4,088
- Board of Trustees of the Leland Stanford Junior University $1,340
- Vision Innovation Centers of Pennsylvania LLC $1,000
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.