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)

Allergan

Status and phase: Completed; Phase 2

Conditions: Choroidal Neovascularization; Age-Related Maculopathy

Treatments: Biological: ranibizumab; Drug: dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00775411

206207-019

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

700 µg dexamethasone and ranibizumab

Experimental group

Description:

700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.

Treatment:

Drug: dexamethasone

Biological: ranibizumab