Trials / Completed
CompletedNCT00915837
Safety and Tolerability Study of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema
Phase 1 Prospective, Randomized, Double-Masked, Multicenter Study to Evaluate the Safety and Tolerability of Two Dose Levels of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- SurModics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This Phase 1 study will evaluate the safety, tolerability and duration of effect of a helical intravitreal triamcinolone implant for the treatment of diabetic macular edema over a three-year period.
Detailed description
The Helical Intravitreal Triamcinolone Implant is intended to provide sustained release of triamcinolone acetonide into the vitreous chamber of the eye.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | triamcinolone acetonide | Helical intravitreal triamcinolone implant- 925 mcg drug; slow release formulation approximately 1-3 mcg/day |
| DRUG | triamcinolone acetonide | Helical intravitreal triamcinolone implant- 925 mcg drug; fast release formulation approximately 3-5 mcg/day |
Timeline
- Start date
- 2005-06-01
- Primary completion
- 2009-04-01
- Completion
- 2009-05-01
- First posted
- 2009-06-08
- Last updated
- 2023-06-09
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00915837. Inclusion in this directory is not an endorsement.