Trials / Completed
CompletedNCT04429503
Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease
A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 660 (actual)
- Sponsor
- Regeneron Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | aflibercept | Intravitreally (IVT) administered as a liquid formulation in a vial |
| DRUG | High-dose aflibercept | Intravitreally (IVT) administered as a liquid formulation in a vial |
Timeline
- Start date
- 2020-06-29
- Primary completion
- 2022-05-30
- Completion
- 2024-06-18
- First posted
- 2020-06-12
- Last updated
- 2025-08-08
- Results posted
- 2023-11-21
Locations
138 sites across 8 countries: United States, Canada, Czechia, Germany, Hungary, Japan, Puerto Rico, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04429503. Inclusion in this directory is not an endorsement.