A Pilot Study for the Treatment of Iris Neovascularization With Macugen

Phase 1

Completed

• Conditions: Iris Neovascularization; Diabetic Retinopathy
• Interventions: Procedure: Panretinal Photocoagulation (PRP); Other: Pegaptanib Sodium Injection/Panretinal Photocoagulation

• Registration Number: NCT00295828
• Lead Sponsor: Hermann Eye Center

Brief Summary

The purpose of this study is to determine if a drug called Macugen may help to stop the growth of abnormal blood vessels on the iris that has occurred in the eye(s) as part of diabetic retinopathy.

Detailed Description

Diabetic retinopathy is an eye condition caused by diabetes in which new blood vessels grow on the retina (the back, inside part of the eye) and the iris. These vessels are not normal and may leak or break, causing bleeding in the eye. This process can lead to vision loss or blindness, glaucoma (disease of the eye where eye pressures are usually too high resulting in damage to the optic nerve), or other eye problems. This study is to determine if a drug called Macugen may help to stop the growth of these abnormal blood vessels on the iris.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-02-22
• Study First Submitted QC: 2006-02-22
• Study First Posted: 2006-02-24
• Status Verified: 2008-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Last Update Submitted: 2008-09-03
• Last Update Posted: 2008-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Panretinal Photocoagulation (PRP)	Panretinal Photocoagulation (PRP)
2	Pegaptanib Sodium Injection/Panretinal Photocoagulation	Panretinal Photocoagulation and Macugen Intravitreal Injection

Primary Outcome Measures

Name	Time	Method
Regression of iris neovascularization and prevention of development of neovascular glaucoma	prospective

Secondary Outcome Measures

Name	Time	Method
Iris angiogram - conducted at screening/treatment visit,week 1, week 3, week 6, week 9, week 12, week 15, week 18, and week 52.	prospective
Regression will be determined by lack of leakage and/or lack of flow through the abnormal vessels.	prospective
Assessment of retina with dilated fundus examination for signs of neovascularization in posterior segment at each follow-up visit	prospective
The complete resolution of iris neovascularization, or regression to less than 2 clock hours of iris neovascularization.	prospective
A clinically significant reduction in the clock hours of angle neovascularization.	prospective
Development of neovascular glaucoma.	prospective

Trial Locations

Locations (1)

Robert Cizik Eye Clinic; 🇺🇸 Houston, Texas, United States