A Pilot Study for the Treatment of Iris Neovascularization With Macugen

Hermann Eye Center

Status and phase: Completed; Phase 1

Conditions: Iris Neovascularization; Diabetic Retinopathy

Treatments: Procedure: Panretinal Photocoagulation (PRP); Other: Pegaptanib Sodium Injection/Panretinal Photocoagulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00295828

HEF-0510

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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).
2. No light perception in the study eye.
3. Inadequate view of retina for PRP/angiography
4. Anterior chamber intraocular lens implant
5. 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.
6. Previous or current Macugen use
7. Any active ocular infection
8. Any conditions which precludes patients ability to comply with study requirements including completion of the study
9. Female patients who are pregnant, nursing, or planning pregnancy, or who are of childbearing potential and not using a reliable means of contraception
10. Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to screening
11. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

1

Active Comparator group

Description:

Panretinal Photocoagulation (PRP)

Treatment:

Procedure: Panretinal Photocoagulation (PRP)

2

Active Comparator group

Description:

Panretinal Photocoagulation and Macugen Intravitreal Injection

Treatment:

Other: Pegaptanib Sodium Injection/Panretinal Photocoagulation