NCT00000159

Brief Summary

To evaluate the safety and efficacy of the investigational drug sorbinil, an aldose reductase inhibitor, in preventing the development of diabetic retinopathy and neuropathy in persons with insulin-dependent diabetes.

Trial Health

100
On Track

Trial Health Score

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

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

August 1, 1983

Completed
16.2 years until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
Last Updated

June 24, 2005

Status Verified

October 1, 1999

First QC Date

September 23, 1999

Last Update Submit

June 23, 2005

Conditions

Diabetic RetinopathyDiabetes Mellitus

Interventions

SorbinilDRUG

Eligibility Criteria

Age18 Years - 56 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Men and women eligible for the SRT had diabetes for 1 to 15 years and were between ages 18 and 56 at the time of enrollment. They had begun taking insulin before their 41st birthday. Their hemoglobin A1c value was within the diabetic range. On retinal examination, they showed no evidence of or only very mild retinopathy, with no more than five microaneurysms per eye. Women were postmenopausal, sterile, or had an IUD in place.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • A randomized trial of sorbinil, an aldose reductase inhibitor, in diabetic retinopathy. Sorbinil Retinopathy Trial Research Group. Arch Ophthalmol. 1990 Sep;108(9):1234-44. doi: 10.1001/archopht.1990.01070110050024.

    PMID: 2119168BACKGROUND

  • The sorbinil retinopathy trial: neuropathy results. Sorbinil Retinopathy Trial Research Group. Neurology. 1993 Jun;43(6):1141-9. doi: 10.1212/wnl.43.6.1141.

    PMID: 8170559BACKGROUND

MeSH Terms

Conditions

Diabetic RetinopathyDiabetes Mellitus

Interventions

sorbinil

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

August 1, 1983

Last Updated

June 24, 2005

Record last verified: 1999-10