Research Study in Patients With Persistent Macular Edema

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.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Embolism and Thrombosis Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Macular Degeneration Macular Edema Metabolic Diseases Nutritional and Metabolic Diseases Panuveitis Retinal Degeneration Retinal Disease Retinal Diseases Retinal Vein Occlusion Thrombosis Uveal Diseases Uveitis Uveitis, Posterior Vascular Diseases Venous Thrombosis

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oculex Pharmaceuticals

Sunnyvale, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DEX PS DDS®

Drug

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Collaborators

Oculex Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start: 2001
Primary completion: 2004
Study completion: 2004
First posted: May 7, 2002
Registry last updated: May 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed