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Research Study in Patients With Persistent Macular Edema
This study has been completed.
Sponsors and Collaborators: Allergan
Occulex
Information provided by: Allergan
ClinicalTrials.gov Identifier: NCT00035906
  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 Intervention Phase
Diabetes
Macular Edema
Diabetic Retinopathy
Retinal Disease
Uveitis, Posterior
Drug: DEX PS DDS®
Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Diabetes Diabetic Eye Problems Edema Retinal Disorders
U.S. FDA Resources
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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035906

Locations
United States, California
Oculex Pharmaceuticals
Sunnyvale, California, United States
Sponsors and Collaborators
Allergan
Occulex
  More Information

Publications indexed to this study:
Study ID Numbers: DC-103-06-03
Study First Received: May 6, 2002
Last Updated: July 12, 2006
ClinicalTrials.gov Identifier: NCT00035906  
Health Authority: United States: Food and Drug Administration

Keywords provided by Allergan:
Diabetes
Macular Edema
Diabetic Macular Edema
Diabetic Retinopathy
Cystoid Macular Edema
Uveitis
Vision
Eye
Retina
Retinal Vein Occlusion
Irvine-Gass Syndrome

Study placed in the following topic categories:
Panuveitis
Uveitis, Posterior
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Retinal Degeneration
Macular Degeneration
Edema
Endocrine System Diseases
Thrombosis
Diabetic Angiopathies
Signs and Symptoms
Macular Edema
Embolism and Thrombosis
Diabetic Retinopathy
Embolism
Uveitis
Retinal Vein Occlusion
Venous Thrombosis
Endocrinopathy
Retinal Diseases
Diabetes Complications
Retinal degeneration

Additional relevant MeSH terms:
Uveal Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009