Phase 2 N=44 Treatment

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)

Choroidal Neovascularization · Age-Related Maculopathy

Bottom Line

View on ClinicalTrials.gov: NCT00775411 ↗

Enrolled (actual)

Serious AEs

13.6%

Results posted

Sep 2012

Primary outcome: Primary: Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4 — 360.9; -62.0 Microns

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: dexamethasone (Drug); ranibizumab (Biological)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4	360.9; -62.0	—
SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26	46.5; 4.5	—
SECONDARY Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26	74.4; 18.6; 7.0	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00775411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.