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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

May 6, 2002
May 27, 2011
October 2001
August 2004   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00035906 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Research Study in Patients With Persistent Macular Edema
Research Study in Patients With Persistent Macular Edema Due to Diabetic Retinopathy, Retinal Vein Occlusion, Uveitis, or Irvine-Gass Syndrome

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
  • Diabetes
  • Macular Edema
  • Diabetic Retinopathy
  • Retinal Disease
  • Uveitis, Posterior
Drug: DEX PS DDS®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
315
August 2004
August 2004   (final data collection date for primary outcome measure)

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.

Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00035906
DC-103-06-03
Not Provided
Therapeutic Area Head, Allergan, Inc
Allergan
Oculex Pharmaceuticals
Not Provided
Allergan
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP