Trials / Completed
CompletedNCT01573572
Extension Study to Gather Data on Effect of Macugen on the Corneal Endothelium
A Phase IV, Open Label, Multi-center Study to Assess the Effect of Intravitreal Injections of Macugen (Pegaptanib Sodium Injection) Administered Every 6 Weeks for 48 Weeks on the Corneal Endothelium.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 131 (actual)
- Sponsor
- Bausch & Lomb Incorporated · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pegaptanib sodium injection | 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks |
Timeline
- Start date
- 2010-04-22
- Primary completion
- 2019-11-14
- Completion
- 2019-11-14
- First posted
- 2012-04-09
- Last updated
- 2021-01-08
- Results posted
- 2020-10-14
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01573572. Inclusion in this directory is not an endorsement.