A Pilot Study for the Treatment of Iris Neovascularization With Macugen

Sponsor
Hermann Eye Center (Other)
Overall Status
Completed
CT.gov ID
NCT00295828
Collaborator
Eyetech Pharmaceuticals (Industry)
10
1
2
32
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pegaptanib Sodium Injection/Panretinal Photocoagulation
  • Procedure: Panretinal Photocoagulation (PRP)
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
A Pilot Study for the Treatment of Iris Neovascularization With Macugen
Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Panretinal Photocoagulation (PRP)

Procedure: Panretinal Photocoagulation (PRP)
Ocular Laser Procedure
Other Names:
  • PRP
  • Active Comparator: 2

    Panretinal Photocoagulation and Macugen Intravitreal Injection

    Other: 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.
    Other Names:
  • Macugen
  • Outcome Measures

    Primary Outcome Measures

    1. Regression of iris neovascularization and prevention of development of neovascular glaucoma [prospective]

    Secondary Outcome Measures

    1. 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]

    2. Regression will be determined by lack of leakage and/or lack of flow through the abnormal vessels. [prospective]

    3. Assessment of retina with dilated fundus examination for signs of neovascularization in posterior segment at each follow-up visit [prospective]

    4. The complete resolution of iris neovascularization, or regression to less than 2 clock hours of iris neovascularization. [prospective]

    5. A clinically significant reduction in the clock hours of angle neovascularization. [prospective]

    6. Development of neovascular glaucoma. [prospective]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Robert Cizik Eye Clinic Houston Texas United States 77030

    Sponsors and Collaborators

    • Hermann Eye Center
    • Eyetech Pharmaceuticals

    Investigators

    • Principal Investigator: Robert M Feldman, MD, Hermann Eye Fund & University of Texas -- Houston

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00295828
    Other Study ID Numbers:
    • HEF-0510
    First Posted:
    Feb 24, 2006
    Last Update Posted:
    Sep 4, 2008
    Last Verified:
    Sep 1, 2008

    Study Results

    No Results Posted as of Sep 4, 2008