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Sponsors and Collaborators: |
Allergan Occulex |
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Information provided by: | Allergan |
ClinicalTrials.gov Identifier: | NCT00035906 |
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 |
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Diabetes Macular Edema Diabetic Retinopathy Retinal Disease Uveitis, Posterior |
Drug: DEX PS DDS® |
Phase II |
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 |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
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.
Study ID Numbers: | DC-103-06-03 |
Study First Received: | May 6, 2002 |
Last Updated: | July 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00035906 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Diabetes Macular Edema Diabetic Macular Edema Diabetic Retinopathy Cystoid Macular Edema Uveitis |
Vision Eye Retina Retinal Vein Occlusion Irvine-Gass Syndrome |
Panuveitis Uveal Diseases 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 |
Panuveitis Uveal Diseases Uveitis, Posterior Eye Diseases Vascular Diseases Diabetes Mellitus Retinal Degeneration Macular Degeneration Endocrine System Diseases Edema Thrombosis |
Diabetic Angiopathies Signs and Symptoms Macular Edema Embolism and Thrombosis Diabetic Retinopathy Uveitis Retinal Vein Occlusion Venous Thrombosis Cardiovascular Diseases Retinal Diseases Diabetes Complications |