A Pilot Study for the Treatment of Iris Neovascularization With Macugen

Completed · Phase 1

Conditions studied: Iris Neovascularization, Diabetic Retinopathy

In brief

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.

Key facts

Study ID

NCT00295828

Run by

Hermann Eye Center

People needed

10

Starts

2006-01-01

Expected to finish

2008-09-01

Last updated by the study team

2008-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, at least 18 years of age
• Diabetic retinopathy with iris neovascularization
• Visual acuity must be light perception or better in the study eye
• Female patients of childbearing potential must have a negative urine pregnancy test at the screening visit.
• Written informed consent has been obtained
• Written authorization for use and release of health and research study information has been obtained

You may not qualify if…

• Neovascular glaucoma ( a difficult form of glaucoma to control that leads to a painful eye with high intraocular pressure, corneal swelling, and "cell and flare" in the anterior chamber. Caused by abnormal new blood vessel formation (neovascularization) on the iris, that extends over trabecular meshwork causing closure of angle drainage structures).
• No light perception in the study eye.
• Inadequate view of retina for PRP/angiography
• Anterior chamber intraocular lens implant
• PRP treatment in the past 60 days. Patients may participate if the PRP treatment is beyond 60 days and has newly diagnosed NVI or has nonregression of previously diagnosed NVI.
• Previous or current Macugen use
• Any active ocular infection
• Any conditions which precludes patients ability to comply with study requirements including completion of the study
• Female patients who are pregnant, nursing, or planning pregnancy, or who are of childbearing potential and not using a reliable means of contraception
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to screening
• Patient has a condition or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results or may interfere significantly with the patient's participation in the study

Where it is running

• Robert Cizik Eye Clinic — Houston, Texas, United States

Full record on ClinicalTrials.gov

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