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A Pilot Study for the Treatment of Iris Neovascularization With Macugen

Primary Purpose

Iris Neovascularization, Diabetic Retinopathy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pegaptanib Sodium Injection/Panretinal Photocoagulation
Panretinal Photocoagulation (PRP)
Sponsored by
Hermann Eye Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iris Neovascularization focused on measuring VEGF, iris neovascularization, diabetic retinopathy, Macugen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Robert Cizik Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Panretinal Photocoagulation (PRP)

Panretinal Photocoagulation and Macugen Intravitreal Injection

Outcomes

Primary Outcome Measures

Regression of iris neovascularization and prevention of development of neovascular glaucoma

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.
Regression will be determined by lack of leakage and/or lack of flow through the abnormal vessels.
Assessment of retina with dilated fundus examination for signs of neovascularization in posterior segment at each follow-up visit
The complete resolution of iris neovascularization, or regression to less than 2 clock hours of iris neovascularization.
A clinically significant reduction in the clock hours of angle neovascularization.
Development of neovascular glaucoma.

Full Information

First Posted
February 22, 2006
Last Updated
September 3, 2008
Sponsor
Hermann Eye Center
Collaborators
Eyetech Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00295828
Brief Title
A Pilot Study for the Treatment of Iris Neovascularization With Macugen
Official Title
A Pilot Study for the Treatment of Iris Neovascularization With Macugen
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hermann Eye Center
Collaborators
Eyetech Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iris Neovascularization, Diabetic Retinopathy
Keywords
VEGF, iris neovascularization, diabetic retinopathy, Macugen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Panretinal Photocoagulation (PRP)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Panretinal Photocoagulation and Macugen Intravitreal Injection
Intervention Type
Other
Intervention Name(s)
Pegaptanib Sodium Injection/Panretinal Photocoagulation
Other Intervention Name(s)
Macugen
Intervention Description
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
Procedure
Intervention Name(s)
Panretinal Photocoagulation (PRP)
Other Intervention Name(s)
PRP
Intervention Description
Ocular Laser Procedure
Primary Outcome Measure Information:
Title
Regression of iris neovascularization and prevention of development of neovascular glaucoma
Time Frame
prospective
Secondary Outcome Measure Information:
Title
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
Title
Regression will be determined by lack of leakage and/or lack of flow through the abnormal vessels.
Time Frame
prospective
Title
Assessment of retina with dilated fundus examination for signs of neovascularization in posterior segment at each follow-up visit
Time Frame
prospective
Title
The complete resolution of iris neovascularization, or regression to less than 2 clock hours of iris neovascularization.
Time Frame
prospective
Title
A clinically significant reduction in the clock hours of angle neovascularization.
Time Frame
prospective
Title
Development of neovascular glaucoma.
Time Frame
prospective

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M Feldman, MD
Organizational Affiliation
Hermann Eye Fund & University of Texas -- Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Cizik Eye Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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A Pilot Study for the Treatment of Iris Neovascularization With Macugen

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