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Research Study in Patients With Persistent Macular Edema

Primary Purpose

Diabetes, Macular Edema, Diabetic Retinopathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DEX PS DDS®
Sponsored by
Allergan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Diabetes, Macular Edema, Diabetic Macular Edema, Diabetic Retinopathy, Cystoid Macular Edema, Uveitis, Vision, Eye, Retina, Retinal Vein Occlusion, Irvine-Gass Syndrome

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oculex Pharmaceuticals

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2002
Last Updated
May 27, 2011
Sponsor
Allergan
Collaborators
Oculex Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00035906
Brief Title
Research Study in Patients With Persistent Macular Edema
Official Title
Research Study in Patients With Persistent Macular Edema Due to Diabetic Retinopathy, Retinal Vein Occlusion, Uveitis, or Irvine-Gass Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Allergan
Collaborators
Oculex Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Macular Edema, Diabetic Retinopathy, Retinal Disease, Uveitis, Posterior
Keywords
Diabetes, Macular Edema, Diabetic Macular Edema, Diabetic Retinopathy, Cystoid Macular Edema, Uveitis, Vision, Eye, Retina, Retinal Vein Occlusion, Irvine-Gass Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DEX PS DDS®

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Oculex Pharmaceuticals
City
Sunnyvale
State/Province
California
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20212197
Citation
Haller JA, Kuppermann BD, Blumenkranz MS, Williams GA, Weinberg DV, Chou C, Whitcup SM; Dexamethasone DDS Phase II Study Group. Randomized controlled trial of an intravitreous dexamethasone drug delivery system in patients with diabetic macular edema. Arch Ophthalmol. 2010 Mar;128(3):289-96. doi: 10.1001/archophthalmol.2010.21.
Results Reference
derived
PubMed Identifier
20212194
Citation
Kuppermann BD, Chou C, Weinberg DV, Whitcup SM, Haller JA, Blumenkranz MS; Dexamethasone DDS Phase II Study Group. Intravitreous dexamethasone effects on different patterns of diabetic macular edema. Arch Ophthalmol. 2010 May;128(5):642-3. doi: 10.1001/archophthalmol.2010.44. Epub 2010 Mar 8. No abstract available.
Results Reference
derived
PubMed Identifier
19268890
Citation
Williams GA, Haller JA, Kuppermann BD, Blumenkranz MS, Weinberg DV, Chou C, Whitcup SM; Dexamethasone DDS Phase II Study Group. Dexamethasone posterior-segment drug delivery system in the treatment of macular edema resulting from uveitis or Irvine-Gass syndrome. Am J Ophthalmol. 2009 Jun;147(6):1048-54, 1054.e1-2. doi: 10.1016/j.ajo.2008.12.033. Epub 2009 Mar 9.
Results Reference
derived
PubMed Identifier
17353400
Citation
Kuppermann BD, Blumenkranz MS, Haller JA, Williams GA, Weinberg DV, Chou C, Whitcup SM; Dexamethasone DDS Phase II Study Group. Randomized controlled study of an intravitreous dexamethasone drug delivery system in patients with persistent macular edema. Arch Ophthalmol. 2007 Mar;125(3):309-17. doi: 10.1001/archopht.125.3.309.
Results Reference
derived

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Research Study in Patients With Persistent Macular Edema

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