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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
Sponsor:
Collaborator:
Oculex Pharmaceuticals
Information provided by:
Allergan

Study Description
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Brief Summary:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
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
Study Start Date : October 2001
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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United States, California
Oculex Pharmaceuticals
Sunnyvale, California, United States
Sponsors and Collaborators
Allergan
Oculex Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier: NCT00035906    
Other Study ID Numbers: DC-103-06-03
First Posted: May 7, 2002    Key Record Dates
Last Update Posted: May 30, 2011
Last Verified: May 2011
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:
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Macular Edema
Retinal Diseases
Diabetic Retinopathy
Uveitis
Retinal Vein Occlusion
Uveitis, Posterior
Edema
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
 Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Uveal Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Panuveitis