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NCT01722045 · ClinicalTrials.gov registry record · Phase 4
Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)
A Phase 4 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 154
- Enrollment target
NCT01722045: Completed Phase 4 study, sponsored by Regeneron Pharmaceuticals.
NCT01722045 is a Phase 4 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 154 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01722045, a Phase 4 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 154 participants
- Enrollment target
Study Summary
This is a phase 4, open-label, single arm, multicenter, clinical study in patients with neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years , and to provide clinical information from the first year in the trial evaluating the adverse effects, if any, on the corneal endothelium following administration of IAI.
Primary Outcome
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed.
Interventions
- DRUG Intravitreal Aflibercept Injection (IAI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2012-11 |
| Est. Completion | 2015-09 |
| Phase | Phase 4 |
What the finished NCT01722045 record still lists
NCT01722045 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Intravitreal Aflibercept Injection (IAI) is the first listed.
NCT01722045 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01722045 about?
NCT01722045 is a clinical study titled "Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)". This is a phase 4, open-label, single arm, multicenter, clinical study in patients with neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years , and to provide clinical information from the first year in the trial evaluating...
What is the current status of trial NCT01722045?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 154 participants. The study started on 2012-11. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01722045?
The interventions under investigation include: Intravitreal Aflibercept Injection (IAI) (DRUG).
Who is sponsoring clinical trial NCT01722045?
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 NCT01722045's enrollment target sits among peer trials
154 528th of 2000 higher than 1,471 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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