Trials / Completed
CompletedNCT04126317
Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
A Randomized, Single-Masked, Active-Controlled Phase 2 Study of the Safety, Tolerability, and Efficacy of Repeated Doses of High-Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- Regeneron Pharmaceuticals · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of the study are to determine the safety of high-dose aflibercept (hereafter referred to as HD) and to determine if HD provides greater intraocular pharmacodynamic (PD) effect and/or longer duration of action compared to intravitreal aflibercept injection (hereafter referred to as IAI).
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
- 2019-11-04
- Primary completion
- 2021-05-14
- Completion
- 2021-11-30
- First posted
- 2019-10-15
- Last updated
- 2023-08-14
- Results posted
- 2023-08-14
Locations
46 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04126317. Inclusion in this directory is not an endorsement.