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NCT01573572 · ClinicalTrials.gov registry record · Phase 4
Extension Study to Gather Data on Effect of Macugen on the Corneal Endothelium
A Phase 4 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 4
- Development phase
- 131
- Enrollment target
NCT01573572: Completed Phase 4 study, sponsored by Bausch & Lomb Incorporated.
NCT01573572 is a Phase 4 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 131 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01573572, a Phase 4 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 131 participants
- Enrollment target
Study Summary
This study was conducted because the FDA requested clinical information on potential effects of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal endothelium from a 1-year (minimum) post-approval clinical study to support that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.
Primary Outcome
The effect on the corneal endothelium will be assessed by specular microscopy, by assessing mean cell density change from baseline. This is to evaluate that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.
Interventions
- DRUG pegaptanib sodium injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2010-04-22 |
| Est. Completion | 2019-11-14 |
| Phase | Phase 4 |
What the finished NCT01573572 record still lists
NCT01573572 is an interventional study that assigns participants to a tested intervention. The registered 131 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 (75% lower).
The record links to 0 conditions, and to 1 intervention - of which pegaptanib sodium injection is the first listed.
NCT01573572 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01573572 about?
NCT01573572 is a clinical study titled "Extension Study to Gather Data on Effect of Macugen on the Corneal Endothelium". This study was conducted because the FDA requested clinical information on potential effects of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal endothelium from a 1-year (minimum) post-approval clinical study to support that there are no adverse effects on the corneal...
What is the current status of trial NCT01573572?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 131 participants. The study started on 2010-04-22. Estimated completion is 2019-11-14.
What interventions are being tested in trial NCT01573572?
The interventions under investigation include: pegaptanib sodium injection (DRUG).
Who is sponsoring clinical trial NCT01573572?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01573572's enrollment target sits among peer trials
131 619th of 2000 higher than 1,379 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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