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NCT00964795 · ClinicalTrials.gov registry record · Phase 3
Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 323
- Enrollment target
NCT00964795: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT00964795 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 323 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00964795, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 323 participants
- Enrollment target
Study Summary
The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.
Primary Outcome
The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE). Treatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs
Interventions
- DRUG Intravitreal Aflibercept Injection 2mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2009-12 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
What the finished NCT00964795 record still lists
NCT00964795 is an interventional study that assigns participants to a tested intervention. The registered 323 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Intravitreal Aflibercept Injection 2mg is the first listed.
NCT00964795 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00964795 about?
NCT00964795 is a clinical study titled "Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)". The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.
What is the current status of trial NCT00964795?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 323 participants. The study started on 2009-12. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00964795?
The interventions under investigation include: Intravitreal Aflibercept Injection 2mg (DRUG).
Who is sponsoring clinical trial NCT00964795?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00964795's enrollment target sits among peer trials
323 1081st of 2000 higher than 920 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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