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A randomised study of sulindac and epalrestat in diabetic retinopathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN54039758
Enrollment
48
Registered
2006-10-12
Start date
1997-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy Eye Diseases Retinal disorders in diseases classified elsewhere

Interventions

1. The sulindac group: patients took 100 mg of sulindac twice a day 2. The epalrestat group: patients took 50 mg of epalrestat three times a day 3. The control group: patients took no additional med

Sponsors

Asama General Hospital (Japan)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of type two diabetes 2. Age 20 years or older 3. Patient consent

Exclusion criteria

Exclusion criteria: 1. Having diabetes for less than five years 2. HbA1c less than 8.0% 3. Taking other medications except for oral hypoglycemic agents or insulin injections 4. Hypertension 5. Inability to understands the implications of the the protocol

Design outcomes

Primary

MeasureTime frame
1. Seven-field stereoscopic retinal photography at baseline, and yearly intervals 2. Endpoint if they were diagnosed with proliferative diabetic retinopathy

Secondary

MeasureTime frame
1. Glycosylated Hemoglobin (GHb) values determine at monthly intervals 2. Remain on their medications for three years 3. Endpoint if exhibited a dipstick proteinuria of more than or equal to 1+

Countries

Japan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026