CompletedPhase 3

Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm

Denmark31 participantsStarted 2018-03-27

Plain-language summary

This study evaluates the effect of melatonin 4 mg on circadian rhythm and visual function of patients with diabetes mellitus. Half of the patients will receive melatonin (arm-1) and the other half will receive placebo (arm-2), both groups in 3 weeks. After a week of washout, the patients will cross over to the other treatment arm.

Who can participate

Age range40 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diabetic patients * Age range 40-75 years * Participant should be legally competent Exclusion Criteria: * Other known eye disease. * Eye disease manifestation during ocular examination. * Competing neurologic and systemic conditions affecting retina. * Use of any drugs influencing pupillary light reflex and sleep pattern. * Refractive error with need of \> 6 diopter lenses. * Pregnancy * Alcohol consumption during the trial * Lack of cooperation * Allergy to melatonin and/or preservatives in melatonin and placebo * Reduced hepatic function * Fluvoxamin intake due to drug interaction * Consumption of Alpha-1 and beta-1 adnergic antagoists. * Alcohol consumption during treatment

What they're measuring

Progression of diabetic retinopathy, oscillary potential

Timeframe: 3 weeks

Trial details

NCT IDNCT03478306

SponsorGlostrup University Hospital, Copenhagen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-12

View on ClinicalTrials.gov More Diabetic Retinopathy trials