Phase 3
Completed N=599
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
Source: ClinicalTrials.gov NCT00168324 ↗Enrolled (actual)
599
Serious AEs
9.1%
Results posted
Aug 2009
Primary outcomePrimary: Cumulative Response Rate of 15 or More Letter Improvement — 0.101; 0.092; 0.045; 0.258 Kaplan-Meier Estimate
Summary
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Response Rate of 15 or More Letter Improvement |
0.101; 0.092; 0.045; 0.258; 0.204; 0.100 | — |
| SECONDARY Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye |
45; 41; 25; 39; 32; 37 | — |
| SECONDARY Change From Baseline in Retinal Thickness in the Study Eye |
548.9; 541.6; 534.4; -199.3; -144.1; -78.2 | — |
| SECONDARY Percentage of Patients With a Change From Baseline in BCVA by Category |
19.4; 16.3; 18.3; 34.8; 37.8; 27.7 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older with macular edema resulting from retinal vein occlusion
- Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
- Visual acuity in other eye no worse than 20/200
Exclusion Criteria
- Known anticipated need for ocular surgery within next 12 months
- History of glaucoma or current high eye pressure requiring more than 1 medication
- Diabetic retinopathy
- Uncontrolled systemic disease
- Known steroid-responder
- Use of systemic steroids
- Use of warfarin/heparin
Data sourced from ClinicalTrials.gov (NCT00168324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.