NCT00406991

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2 diabetes

Timeline
Completed

Started Jun 2003

Typical duration for phase_2 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
Last Updated

October 30, 2015

Status Verified

March 1, 2006

First QC Date

November 30, 2006

Last Update Submit

October 28, 2015

Conditions

DiabetesDiabetic Retinopathy

Keywords

retinal blood flowdiabetic retinopathymicrothrombosisaspirinclopidogrel

Outcome Measures

Primary Outcomes (1)

  • Retinal blood flow

Secondary Outcomes (2)

  • Retinal arterial blood speed

  • Retinal arterial diameter

Interventions

aspirinDRUG
clopidogrelDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-45 years,
  • type 1 diabetes duration 1-15 years,
  • absent or minimal retinopathy (EDTRS 20).
  • Age- and gender-matched healthy controls

You may not qualify if:

  • smoking,
  • systemic diseases other than diabetes,
  • retinal diseases other than diabetic retinopathy,
  • pregnancy,
  • bleeding disorders,
  • aspirin allergy,
  • use of anti-platelet agents,
  • non-steroidal anti-inflammatory agents,
  • angiotensin converting enzyme inhibitors,
  • angiotensin receptor antagonists,
  • Vitamin E in large doses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schepens Eye Research Institute

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Interventions

AspirinClopidogrel

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mara Lorenzi, MD

    Schepens Eye Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

June 1, 2003

Study Completion

March 1, 2006

Last Updated

October 30, 2015

Record last verified: 2006-03

Locations

US(1)