Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD)

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with choroidal neovascularization secondary to age-related macular degeneration. Subjects will be followed for 26 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Endothelial Growth Factors; Ranibizumab

Criteria

Inclusion Criteria:

• 50 years of age or older with active subfoveal choroidal neovascularization (CNV) secondary to AMD

• Central retinal thickness ≥ 300 µm

• Visual acuity between 20/400 and 20/32

• Eligible for Anti-VEGF therapy

Exclusion Criteria:

• Previous treatment for CNV due to AMD

• High eye pressure

• Glaucoma

• Uncontrolled systemic disease

• Known allergy to the study medications

• Recent eye surgery or injections in the eye

• Female subjects that are of childbearing potential