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)

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Allergan
Study ID
NCT00775411
Phase
PHASE2
Status
Completed

Conditions

  • Age-Related Maculopathy
  • Choroidal Neovascularization

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Oct 20, 2008
Start date
Nov 30, 2008
Status verified
Aug 2012
Primary completion
Nov 30, 2009
Completion
Apr 30, 2010

Study Design

Enrollment
44 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 700 µg dexamethasone and ranibizumab
    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.

Primary Outcome Measure

Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4 [ Time Frame: Baseline, Week 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-San AntonioTexas--

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