Research Study in Patients With Persistent Macular Edema
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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 |
Eligibility| 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.
Contacts and Locations 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:
|
Diabetes Mellitus Diabetic Retinopathy Edema Macular Edema Retinal Diseases Retinal Vein Occlusion Uveitis Chorioretinitis Uveitis, Posterior Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Eye Diseases Diabetic Angiopathies |
Vascular Diseases Cardiovascular Diseases Diabetes Complications Signs and Symptoms Macular Degeneration Retinal Degeneration Venous Thrombosis Thrombosis Embolism and Thrombosis Uveal Diseases Retinitis Choroiditis Choroid Diseases Panuveitis |
ClinicalTrials.gov processed this record on June 13, 2013