A Pilot Study for the Treatment of Iris Neovascularization With Macugen - Full Text View

Sponsors and Collaborators:	Hermann Eye Center Eyetech Pharmaceuticals
Information provided by:	Hermann Eye Center
ClinicalTrials.gov Identifier:	NCT00295828

Purpose

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	Intervention	Phase
Iris Neovascularization Diabetic Retinopathy	Other: Pegaptanib Sodium Injection/Panretinal Photocoagulation Procedure: Panretinal Photocoagulation (PRP)	Phase I

MedlinePlus related topics: Diabetic Eye Problems Glaucoma Retinal Disorders

Drug Information available for: Pegaptanib sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study
Official Title:	A Pilot Study for the Treatment of Iris Neovascularization With Macugen

Further study details as provided by Hermann Eye Center:

Primary Outcome Measures:

Regression of iris neovascularization and prevention of development of neovascular glaucoma [ Time Frame: prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Regression will be determined by lack of leakage and/or lack of flow through the abnormal vessels. [ Time Frame: prospective ] [ Designated as safety issue: No ]
Assessment of retina with dilated fundus examination for signs of neovascularization in posterior segment at each follow-up visit [ Time Frame: prospective ] [ Designated as safety issue: No ]
The complete resolution of iris neovascularization, or regression to less than 2 clock hours of iris neovascularization. [ Time Frame: prospective ] [ Designated as safety issue: No ]
A clinically significant reduction in the clock hours of angle neovascularization. [ Time Frame: prospective ] [ Designated as safety issue: No ]
Development of neovascular glaucoma. [ Time Frame: prospective ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	January 2006
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Panretinal Photocoagulation (PRP)	Procedure: Panretinal Photocoagulation (PRP) Ocular Laser Procedure
2: Active Comparator 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

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

Exclusion criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295828

Locations

United States, Texas
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

More Information

Responsible Party:	Hermann Eye Center ( Robert M. Feldman, MD )
Study ID Numbers:	HEF-0510
Study First Received:	February 22, 2006
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00295828
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hermann Eye Center:

VEGF
iris neovascularization
diabetic retinopathy
Macugen

Study placed in the following topic categories:

Diabetic Retinopathy
Metaplasia
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases

Endocrinopathy
Neovascularization, Pathologic
Diabetes Complications
Retinal Diseases
Diabetic Angiopathies

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009