Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy

Sponsor

National Eye Institute (NEI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00411333

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The retinal vasculature changes dramatically in patients with diabetic retinopathy especially between non-proliferative and proliferative disease. The retinal vasculature can be imaged and quantified using special dyes. This study will test whether the pattern of the retinal vasculature changes in patients with different levels of diabetic retinopathy can be quantified using computerized image analysis. In addition, the study will evaluate whether new drugs to treat diabetic retinopathy will be able to reverse these vascular changes.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Drug: triamcinolone acetonide (Kenalog)	Early Phase 1

Detailed Description

In this study, we are studying whether vascular density decreases during diabetic retinopathy prior to the pathological neovascularization seen in proliferative disease that results in blindness in more than 50 percent of patients, and whether the adverse, early vascular remodeling and neovascularization can be reversed by anti-angiogenic therapeutics. We have shown that vascular density decreases during early stages of diabetic retinopathy, prior to the pathological neovascularization that defines proliferative retinopathy, and that this change may be reversible with new anti-angiogenic therapeutics. To test this hypothesis we will determine (1) how blood vessels remodel and whether vascular density truly decreases during diabetic retinopathy and (2) how the anti-angiogenic steroid triamcinolone acetonide affects vascular density and pattern during human diabetic retinopathy and in our experimental model, the avian CAM model.

Twenty patients (n = 20) for each of the 4 NPDR stages will be enrolled. In addition, a control group of 20 normal subjects will be recruited from the same clinical practice that do not have diabetes and no evidence of any vascular disease, for a total of 100 patients in the clinical trial.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Outcome Measures

Primary Outcome Measures

Change in retinal vascular density from baseline on fluorescein angiography []

Secondary Outcome Measures

Safety []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Presence of mild, moderate, severe, or very severe non-proliferative diabetic retinopathy (defined as ETDRS level >10) in at least one eye (based on ETDRS criteria)

Exclusion Criteria:

Any condition that might impair the patient's ability to give informed consent
Any condition or media opacity that might impair the patient's ability to perform vision tests, color fundus photographs or fluorescein angiography
Severe allergy or other contraindication to sodium fluorescein dye
Participating in any other ophthalmic clinical trial