Retinal Blood Flow & Microthrombi in Type 1 Diabetes

Status Completed

Clinical Trial Summary

The project aims to find mechanisms for the abnormal retinal blood flow that in diabetic patients often precedes any evidence of clinical retinopathy and may contribute to the development of retinopathy.

Specifically, the projects tests the hypothesis that reduced retinal blood flow found in young patients with type 1 diabetes reflects increased resistance in the small vessels of the retina caused by the formation of small blood clots, called microthrombi; and that antiplatelet agents normalize the reduced retinal blood flow.

Clinical Trial Description

The ultimate goal of this research is to contribute to the development of strategies to prevent diabetic retinopathy. This project will test the hypothesis that antiplatelet agents normalize the reduced blood flow observed early in the course of type 1 diabetes. If the hypothesis is proven correct, the results will indicate that the formation of small blood clots (microthrombi) occurs early in diabetic retinal vessels. In turn, because microthrombosis could readily account for the occlusive microangiopathy that causes the sight-threatening stages of diabetic retinopathy, the results will propose the desirability of antiplatelet therapy for the prevention of diabetic retinopathy.

We have three specific aims:

1. To confirm that, under basal conditions, retinal blood flow measured with the laser Doppler method in a group of type 1 diabetic patients with no or minimal retinopathy differs from the flow measured in age- and sex-matched nondiabetic control subjects;

2. To determine whether the response of retinal blood flow to low-dose aspirin (81 mg/day) administered for 2 months versus placebo, differs between type 1 diabetic patients with no or minimal retinopathy and age- and sex-matched nondiabetic control subjects;

3. To determine whether in type 1 diabetic patients with no or minimal retinopathy the response of retinal blood flow to low-dose aspirin differs from the response to clopidogrel, a drug that interferes with platelet function downstream of the site of aspirin action. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00406991
Study type	Interventional
Source	Massachusetts Eye and Ear Infirmary
Contact
Status	Completed
Phase	Phase 2
Start date	June 2003
Completion date	March 2006

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Retinal Blood Flow and Microthrombi in Type 1 Diabetes

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms