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Research Study in Patients With Persistent Macular Edema

This study has been completed.
Oculex Pharmaceuticals
Information provided by:
Allergan Identifier:
First received: May 6, 2002
Last updated: May 27, 2011
Last verified: May 2011

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Research Study in Patients With Persistent Macular Edema Due to Diabetic Retinopathy, Retinal Vein Occlusion, Uveitis, or Irvine-Gass Syndrome

Resource links provided by NLM:

Further study details as provided by Allergan:

Enrollment: 315
Study Start Date: October 2001
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00035906

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Allergan, Inc Identifier: NCT00035906     History of Changes
Other Study ID Numbers: DC-103-06-03
Study First Received: May 6, 2002
Last Updated: May 27, 2011

Keywords provided by Allergan:
Macular Edema
Diabetic Macular Edema
Diabetic Retinopathy
Cystoid Macular Edema
Retinal Vein Occlusion
Irvine-Gass Syndrome

Additional relevant MeSH terms:
Macular Edema
Retinal Diseases
Diabetic Retinopathy
Retinal Vein Occlusion
Uveitis, Posterior
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Uveal Diseases
Venous Thrombosis
Embolism and Thrombosis
Panuveitis processed this record on September 21, 2017