A Pilot Study for the Treatment of Iris Neovascularization With Macugen

Diabetic Retinopathy Clinical Trial

Official title:

A Pilot Study for the Treatment of Iris Neovascularization With Macugen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295828
• Other study ID #: HEF-0510
• Status: Completed
• Phase: Phase 1
• First received: February 22, 2006
• Last updated: September 3, 2008
• Start date: January 2006
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Hermann Eye Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Iris Neovascularization
• Neovascularization, Pathologic
• Retinal Diseases

Intervention

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.

Procedure:
• Panretinal Photocoagulation (PRP)
Ocular Laser Procedure

Locations

Country	Name	City	State
United States	Robert Cizik Eye Clinic	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Hermann Eye Center	Eyetech Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regression of iris neovascularization and prevention of development of neovascular glaucoma		prospective	No
Secondary	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	No
Secondary	Regression will be determined by lack of leakage and/or lack of flow through the abnormal vessels.		prospective	No
Secondary	Assessment of retina with dilated fundus examination for signs of neovascularization in posterior segment at each follow-up visit		prospective	No
Secondary	The complete resolution of iris neovascularization, or regression to less than 2 clock hours of iris neovascularization.		prospective	No
Secondary	A clinically significant reduction in the clock hours of angle neovascularization.		prospective	No
Secondary	Development of neovascular glaucoma.		prospective	No