Status:
COMPLETED
Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Bayer
Conditions:
Diabetic Macular Edema
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 afl...
Eligibility Criteria
Inclusion
- Key
- Diabetic macular edema (DME) with central involvement in the study eye
- Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of DME
- Willing and able to comply with clinic visits and study-related procedures
- Provide informed consent signed by study participant or legally acceptable representative
- Extension Phase: All randomized patients that complete visit 26, week 96, as long as the patient 1) provides informed consent and 2) no treatment for DME has been given in the study eye other than the randomized study treatment.
- Key
Exclusion
- Evidence of macular edema due to any cause other than diabetes mellitus in either eye
- Active proliferative diabetic retinopathy in the study eye
- IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye
- Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time
- Treatment with ocriplasmin (JETREA®) in the study eye at any time
- NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply
Key Trial Info
Start Date :
June 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2024
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT04429503
Start Date
June 29 2020
End Date
June 18 2024
Last Update
August 8 2025
Active Locations (138)
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1
Regeneron Study Site
Phoenix, Arizona, United States, 85021
2
Regeneron Study Site
Arcadia, California, United States, 91006
3
Regeneron Study Site
Beverly Hills, California, United States, 90211
4
Regeneron Study Site
Campbell, California, United States, 95008