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)

Part of paid clinical trials in Boynton Beach, Florida.

Sponsor
Allergan
Study ID
NCT00511706
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
    Intravitreal injection of dexamethasone 700 µg at Day 1.
  • ranibizumab — BIOLOGICAL
    Ranibizumab 500 µg at day -30 and Day 7-14.
  • sham — OTHER
    Sham needle-less injection administered in the study eye at Day 1.

Study Details

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.

Key Dates

First listed
Aug 6, 2007
Start date
Nov 1, 2007
Status verified
Apr 2019
Primary completion
Mar 1, 2009
Completion
Mar 1, 2009

Study Design

Enrollment
243 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: dexamethasone and ranibizumab
    Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
  • Sham Comparator: sham and ranibizumab
    Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.

Primary Outcome Measure

Injection Free Interval [ Time Frame: Week 1 to Week 25 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-Boynton BeachFlorida--

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