A Pilot Study for the Treatment of Iris Neovascularization With Macugen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00295828
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : September 4, 2008
Eyetech Pharmaceuticals
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Iris Neovascularization Diabetic Retinopathy 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 Type : Interventional  (Clinical Trial)
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 : January 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Panretinal Photocoagulation (PRP)
Procedure: Panretinal Photocoagulation (PRP)
Ocular Laser Procedure
Other Name: 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 Name: Macugen

Primary Outcome Measures :
  1. Regression of iris neovascularization and prevention of development of neovascular glaucoma [ Time Frame: 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. [ Time Frame: prospective ]
  2. Regression will be determined by lack of leakage and/or lack of flow through the abnormal vessels. [ Time Frame: prospective ]
  3. Assessment of retina with dilated fundus examination for signs of neovascularization in posterior segment at each follow-up visit [ Time Frame: prospective ]
  4. The complete resolution of iris neovascularization, or regression to less than 2 clock hours of iris neovascularization. [ Time Frame: prospective ]
  5. A clinically significant reduction in the clock hours of angle neovascularization. [ Time Frame: prospective ]
  6. Development of neovascular glaucoma. [ Time Frame: prospective ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00295828

United States, Texas
Robert Cizik Eye Clinic
Houston, Texas, United States, 77030
Sponsors and Collaborators
Hermann Eye Center
Eyetech Pharmaceuticals
Principal Investigator: Robert M Feldman, MD Hermann Eye Fund & University of Texas -- Houston

Responsible Party: Robert M. Feldman, MD, Hermann Eye Center Identifier: NCT00295828     History of Changes
Other Study ID Numbers: HEF-0510
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: September 4, 2008
Last Verified: September 2008

Keywords provided by Hermann Eye Center:
iris neovascularization
diabetic retinopathy

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Neovascularization, Pathologic
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pathologic Processes