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| Name | Class |
|---|---|
| Eyetech Pharmaceuticals | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Panretinal Photocoagulation (PRP) |
|
| 2 | Active Comparator | Panretinal Photocoagulation and Macugen Intravitreal Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegaptanib Sodium Injection/Panretinal Photocoagulation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Regression of iris neovascularization and prevention of development of neovascular glaucoma | prospective |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Regression will be determined by lack of leakage and/or lack of flow through the abnormal vessels. | prospective |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert M Feldman, MD | Hermann Eye Fund & University of Texas -- Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Cizik Eye Clinic | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C495058 | pegaptanib |
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|
| Panretinal Photocoagulation (PRP) | Procedure | Ocular Laser Procedure |
|
|
| Assessment of retina with dilated fundus examination for signs of neovascularization in posterior segment at each follow-up visit | prospective |
| The complete resolution of iris neovascularization, or regression to less than 2 clock hours of iris neovascularization. | prospective |
| A clinically significant reduction in the clock hours of angle neovascularization. | prospective |
| Development of neovascular glaucoma. | prospective |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |