Overview

Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy

Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
National Eye Institute (NEI)
Treatments:
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Criteria
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