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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)

NCT00775411 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-09-03

Study results available
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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.

Conditions

  • Choroidal Neovascularization
  • Age-Related Maculopathy

Interventions

DRUG

dexamethasone

700 µg dexamethasone intravitreal injection at Day 1 in the study eye.

BIOLOGICAL

ranibizumab

Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-11-30
Completion
2010-04-30

Countries

  • United States
  • Australia
  • Philippines

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 NCT00775411 on ClinicalTrials.gov