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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)

NCT00511706 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2019-04-25

Study results available
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Summary

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.

Conditions

  • Choroidal Neovascularization
  • Age-Related Maculopathy

Interventions

DRUG

dexamethasone

Intravitreal injection of dexamethasone 700 µg at Day 1.

BIOLOGICAL

ranibizumab

Ranibizumab 500 µg at day -30 and Day 7-14.

OTHER

sham

Sham needle-less injection administered in the study eye at Day 1.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-01
Primary Completion
2009-03-01
Completion
2009-03-01

Countries

  • United States
  • Australia
  • France
  • Israel
  • Italy
  • New Zealand
  • Portugal
  • South Korea
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00511706 on ClinicalTrials.gov