Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy

This study has been completed.
Sponsor:
Information provided by:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00411333
First received: December 13, 2006
Last updated: November 9, 2010
Last verified: November 2010

December 13, 2006
November 9, 2010
July 2006
July 2009   (final data collection date for primary outcome measure)
Change in retinal vascular density from baseline on fluorescein angiography
Same as current
Complete list of historical versions of study NCT00411333 on ClinicalTrials.gov Archive Site
Safety
Same as current
Not Provided
Not Provided
 
Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy
Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy

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.

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.

Interventional
Phase 0
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetic Retinopathy
Drug: triamcinolone acetonide (Kenalog)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00411333
R01 EY017528-0
Not Provided
Not Provided
National Eye Institute (NEI)
Not Provided
Principal Investigator: Peter K Kaiser, MD Cole Eye Institute
National Eye Institute (NEI)
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP