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Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema

NCT00464685 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2019-04-24

Study results available
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Summary

This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.

Conditions

Interventions

DRUG

Dexamethasone

Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria.

DRUG

Sham injection

Initial sham injection with up to 1 additional treatment based on re-treatment criteria.

PROCEDURE

Laser Photocoagulation

Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-01
Primary Completion
2010-02-08
Completion
2010-02-08

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
Diseases

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 NCT00464685 on ClinicalTrials.gov