Overview

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

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
Summary
The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.
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 subfoveal choroidal neovascularization (CNV) (classic
and/or occult) secondary to AMD

- Visual Acuity between 20/40 and 20/400 in the study eye

Exclusion Criteria:

- Any intraocular surgery within 3 months

- Glaucoma

- Cataract

- High eye pressure

- Uncontrolled systemic disease