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A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

NCT00168298 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 668

Last updated 2019-04-23

Study results available
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Summary

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.

Conditions

  • Macular Edema
  • Retinal Vein Occlusion

Interventions

DRUG

700 µg Dexamethasone

700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.

DRUG

350 µg Dexamethasone

350 µg Dexamethasone intravitreal implant administered on Day 0.

OTHER

Sham Injection

Sham injection on Day 0.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-01
Primary Completion
2008-03-01
Completion
2008-09-05

Countries

  • United States
  • Brazil
  • Canada
  • Colombia
  • Hong Kong
  • India
  • Italy
  • New Zealand
  • Poland
  • Singapore
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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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 NCT00168298 on ClinicalTrials.gov