Research Study in Patients With Persistent Macular Edema

Phase 2

Completed

• Conditions: Diabetes; Macular Edema; Diabetic Retinopathy; Retinal Disease; Uveitis, Posterior

• Registration Number: NCT00035906
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2002-05-06
• Study First Submitted QC: 2002-05-06
• Study First Posted: 2002-05-07
• Primary Completion: 2004-08
• Study Completion: 2004-08
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-27
• Last Update Posted: 2011-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Oculex Pharmaceuticals; 🇺🇸 Sunnyvale, California, United States