Phase 3
N=262
Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT01660802 ↗Enrolled (actual)
262
Serious AEs
1.2%
Results posted
Jun 2015
Primary outcome: Primary: Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye — 60; 31 Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 700 μg Dexamethasone (Drug); Sham (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 2014
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 |
60; 31 | — |
| SECONDARY Average Change From Baseline in BCVA in the Study Eye |
52.6; 53.1; 6.6; 2.5 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye |
52.6; 53.1; 9.1; 2.0; 10.6; 1.7 | — |
| SECONDARY Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye |
28.7; 5.4; 34.9; 11.5; 33.3; 13.1 | — |
Summary
This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.
Eligibility Criteria
Inclusion Criteria
-Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
Exclusion Criteria
- History of glaucoma, ocular hypertension or optic nerve head change
- Any active bacterial, viral, parasitic, or fungal infections in either eye
- Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start
- History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start
- Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start
- Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start
- Use of topical ophthalmic corticosticosteroids within 2 weeks of study start
Data sourced from ClinicalTrials.gov (NCT01660802). 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.