Clinical Trial: Research Study in Patients with Persistent Macular Edema

This study is no longer recruiting patients.

Sponsored by: Oculex Pharmaceuticals
Information provided by: Oculex Pharmaceuticals

Purpose

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.

Condition Treatment or Intervention Phase
Diabetes
Macular Edema
Diabetic Retinopathy
Retinal Disease
Uveitis, Posterior
 Drug: DEX PS DDS®
Phase II

MedlinePlus related topics:  Diabetes;   Diabetic Eye Problems;   Eye Diseases;   Retinal Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title: Research Study in Patients with Persistent Macular Edema due to Diabetic Retinopathy, Retinal Vein Occlusion, Uveitis, or Irvine-Gass Syndrome

Eligibility

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Criteria

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.


Location Information


California
      Oculex Pharmaceuticals, Sunnyvale,  California,  United States

More Information

Study ID Numbers:  DC-103-06-03
Record last reviewed:  September 2002
Last Updated:  October 13, 2004
Record first received:  May 6, 2002
ClinicalTrials.gov Identifier:  NCT00035906
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005