Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
Overview
- Phase
- Phase 3
- Intervention
- 700 μg Dexamethasone
- Conditions
- Macular Edema
- Sponsor
- Allergan
- Enrollment
- 262
- Primary Endpoint
- Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
700 μg Dexamethasone
700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
Intervention: 700 μg Dexamethasone
Sham
Sham administered in the study eye on Day 1.
Intervention: 700 μg Dexamethasone
Sham
Sham administered in the study eye on Day 1.
Intervention: Sham
Outcomes
Primary Outcomes
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time Frame: Baseline, 6 Months
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.
Secondary Outcomes
- Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye(Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6)
- Change From Baseline in BCVA in the Study Eye(Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6)
- Average Change From Baseline in BCVA in the Study Eye(Baseline, 6 Months)