NCT00035906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for phase_2 diabetes

Timeline
Completed

Started Oct 2001

Typical duration for phase_2 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2002

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

May 30, 2011

Status Verified

May 1, 2011

Enrollment Period

2.8 years

First QC Date

May 6, 2002

Last Update Submit

May 27, 2011

Conditions

DiabetesMacular EdemaDiabetic RetinopathyRetinal DiseaseUveitis, Posterior

Keywords

DiabetesMacular EdemaDiabetic Macular EdemaDiabetic RetinopathyCystoid Macular EdemaUveitisVisionEyeRetinaRetinal Vein OcclusionIrvine-Gass Syndrome

Interventions

DEX PS DDS®DRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oculex Pharmaceuticals

Sunnyvale, California, United States

Location

Related Publications (4)

  • 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.

    PMID: 20212197DERIVED

  • 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.

    PMID: 20212194DERIVED

  • 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.

    PMID: 19268890DERIVED

  • 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.

    PMID: 17353400DERIVED

MeSH Terms

Conditions

Diabetes MellitusMacular EdemaDiabetic RetinopathyRetinal DiseasesUveitis, PosteriorUveitisRetinal Vein Occlusion

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMacular DegenerationRetinal DegenerationEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsPanuveitisUveal DiseasesVenous ThrombosisThrombosisEmbolism and Thrombosis

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 6, 2002

First Posted

May 7, 2002

Study Start

October 1, 2001

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

May 30, 2011

Record last verified: 2011-05

Locations

US(1)