Research Study in Patients With Persistent Macular Edema

This study has been completed.
Sponsor:
Collaborator:
Oculex Pharmaceuticals
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00035906
First received: May 6, 2002
Last updated: May 27, 2011
Last verified: May 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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)
  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
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 ClinicalTrials.gov identifier: NCT00035906

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

No publications provided by Allergan

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

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Diseases
Uveitis
Chorioretinitis
Diabetic Retinopathy
Retinal Vein Occlusion
Uveitis, Posterior
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases
Uveal Diseases
Retinitis
Choroiditis
Choroid Diseases
Panuveitis
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis

ClinicalTrials.gov processed this record on September 30, 2014