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

Phase 3

Completed

• Conditions: Diabetic Retinopathy; Melatonin; Circadian Dysrhythmia; Circadian Rhythm Sleep Disorder, Unspecified Type
• Interventions: Drug: Melatonin 4 mg Tablet

• Registration Number: NCT03478306
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-20
• Study Start: 2018-03-27
• Study First Posted: 2018-03-27
• Primary Completion: 2021-06-12
• Study Completion: 2021-06-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Melatonin 4 mg Tablet	Melatonin, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.
Arm 2	Melatonin 4 mg Tablet	Place, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.

Primary Outcome Measures

Name	Time	Method
Progression of diabetic retinopathy, oscillary potential	3 weeks	Progression of diabetic retinopati measured with electroretinography

Secondary Outcome Measures

Name	Time	Method
Post-illumination pupillary light response	3 weeks	Melanopsin-mediated pupillary response
Circadian photoentrainment	3 weeks	Salivary melatonin level and sleep assessment
Retinal structure	3 weeks	Retinal structure assessed by optical coherence tomography

Trial Locations

Locations (1)

Department of Ophthalmology, Rigshospitalet-Glostrup; 🇩🇰 Glostrup, RegionH, Denmark