Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:

Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411333
• Other study ID #: R01 EY017528-0
• Status: Completed
• Phase: Phase 0
• First received: December 13, 2006
• Last updated: November 9, 2010
• Start date: July 2006
• Est. completion date: July 2009

Study information

• Verified date: November 2010
• Source: National Eye Institute (NEI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• triamcinolone acetonide (Kenalog)

Locations

Country	Name	City	State
United States	Cole Eye Institute	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Parsons-Wingerter P, Radhakrishnan K, Vickerman MB, Kaiser PK. Oscillation of angiogenesis with vascular dropout in diabetic retinopathy by VESsel GENeration analysis (VESGEN). Invest Ophthalmol Vis Sci. 2010 Jan;51(1):498-507. doi: 10.1167/iovs.09-3968. — View Citation

Vickerman MB, Keith PA, McKay TL, Gedeon DJ, Watanabe M, Montano M, Karunamuni G, Kaiser PK, Sears JE, Ebrahem Q, Ribita D, Hylton AG, Parsons-Wingerter P. VESGEN 2D: automated, user-interactive software for quantification and mapping of angiogenic and ly — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in retinal vascular density from baseline on fluorescein angiography
Secondary	Safety