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)

Allergan

Status and phase: Completed; Phase 2

Conditions: Choroidal Neovascularization; Age-Related Maculopathy

Treatments: Biological: ranibizumab; Other: sham; Drug: dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00511706

206207-016

Details and patient eligibility

About

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.

Enrollment: 243 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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243 participants in 2 patient groups

dexamethasone and ranibizumab

Experimental group

Description:

Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.

Treatment:

Drug: dexamethasone

Biological: ranibizumab

sham and ranibizumab

Sham Comparator group

Description:

Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.

Treatment:

Biological: ranibizumab

Other: sham