Research Study in Patients With Persistent Macular Edema

Diabetes Clinical Trial

Official title:

Research Study in Patients With Persistent Macular Edema Due to Diabetic Retinopathy, Retinal Vein Occlusion, Uveitis, or Irvine-Gass Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035906
• Other study ID #: DC-103-06-03
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2002
• Last updated: May 27, 2011
• Start date: October 2001
• Est. completion date: August 2004

Study information

• Verified date: May 2011
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical research study is to evaluate the safety and effectiveness of an investigational medication to treat macular edema that persists despite current treatment methods. Participants will be evaluated for improvement in vision and side effects.

Macular edema is a condition that affects the back of the eye (retina). It frequently occurs in people who have a history of diabetes, and is also associated with high blood pressure, uveitis, and previous eye surgery. The main symptom of macular edema is decreased vision, generally a blurring of central vision.

There are no direct costs to participants for assessments and treatment as defined in the study protocol. All candidates must be available for required scheduled visits during the trial's 6-month follow-up period. Although the disease called age-related macular degeneration (AMD) affects the same region of the eye as macular edema, they are not the same condition and AMD is not studied in this research trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion: Persistent macular edema associated with diabetic retinopathy, uveitis, retinal vein occlusion, or Irvine-Gass syndrome, persisting at least 90 days after laser treatment or medical management by a physician.

Exclusion: Females who are pregnant or lactating, and females of childbearing potential not using adequate birth control for the duration of the study. Any intraocular procedures or laser treatment less than 90 days before enrollment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetic Retinopathy
• Edema
• Macular Edema
• Retinal Disease
• Retinal Diseases
• Retinal Vein Occlusion
• Uveitis
• Uveitis, Posterior

Intervention

Drug:
• DEX PS DDS®

Locations

Country	Name	City	State
United States	Oculex Pharmaceuticals	Sunnyvale	California

Sponsors (2)

Lead Sponsor	Collaborator
Allergan	Oculex Pharmaceuticals

Country where clinical trial is conducted

United States,