Phase 3
N=668
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
Macular Edema · Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT00168298 ↗Enrolled (actual)
668
Serious AEs
6.1%
Results posted
Aug 2009
Primary outcome: Primary: Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye — 53; 48; 38 Number of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 700 µg Dexamethasone (Drug); 350 µg Dexamethasone (Drug); Sham Injection (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye |
53; 48; 38 | — |
| SECONDARY Change From Baseline in Retinal Thickness in the Study Eye |
573.6; 566.6; 542.5; -215.6; -205.5; -91.1 | — |
| SECONDARY Percentage of Patients With a Change From Baseline in BCVA by Category |
23.5; 21.6; 17.0; 35.0; 33.9; 28.6 | — |
| SECONDARY Percentage of Patients With a Change From Baseline in BCVA by Category |
23.5; 21.6; 17.0; 35.0; 33.9; 28.6 | — |
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.
Eligibility Criteria
Key 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
Key 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 (NCT00168298). 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.