Research Study in Patients With Persistent Macular Edema
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00035906|
Recruitment Status : Completed
First Posted : May 7, 2002
Last Update Posted : May 30, 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 or disease||Intervention/treatment||Phase|
|Diabetes Macular Edema Diabetic Retinopathy Retinal Disease Uveitis, Posterior||Drug: DEX PS DDS®||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||315 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Research Study in Patients With Persistent Macular Edema Due to Diabetic Retinopathy, Retinal Vein Occlusion, Uveitis, or Irvine-Gass Syndrome|
|Study Start Date :||October 2001|
|Actual Primary Completion Date :||August 2004|
|Actual Study Completion Date :||August 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035906
|United States, California|
|Sunnyvale, California, United States|