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A Pilot Study for the Treatment of Iris Neovascularization With Macugen

NCT ID: NCT00295828

Last Updated: 2008-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-09-30

Brief Summary

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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

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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.

Conditions

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Iris Neovascularization Diabetic Retinopathy

Keywords

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VEGF iris neovascularization diabetic retinopathy Macugen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Panretinal Photocoagulation (PRP)

Group Type ACTIVE_COMPARATOR

Panretinal Photocoagulation (PRP)

Intervention Type PROCEDURE

Ocular Laser Procedure

2

Panretinal Photocoagulation and Macugen Intravitreal Injection

Group Type ACTIVE_COMPARATOR

Pegaptanib Sodium Injection/Panretinal Photocoagulation

Intervention Type OTHER

Pegaptanib Sodium Injection is a single dose prefilled syringe and is formulated as a 3.47 mg/mL solution. Combined with an ocular laser procedure.

Interventions

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Pegaptanib Sodium Injection/Panretinal Photocoagulation

Pegaptanib Sodium Injection is a single dose prefilled syringe and is formulated as a 3.47 mg/mL solution. Combined with an ocular laser procedure.

Intervention Type OTHER

Panretinal Photocoagulation (PRP)

Ocular Laser Procedure

Intervention Type PROCEDURE

Other Intervention Names

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Macugen PRP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eyetech Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Hermann Eye Center

OTHER

Sponsor Role lead

Responsible Party

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Hermann Eye Center

Principal Investigators

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Robert M Feldman, MD

Role: PRINCIPAL_INVESTIGATOR

Hermann Eye Fund & University of Texas -- Houston

Locations

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Robert Cizik Eye Clinic

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HEF-0510

Identifier Type: -

Identifier Source: org_study_id