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

Glostrup University Hospital, Copenhagen

Status and phase: Completed; Phase 3

Conditions: Circadian Dysrhythmia; Circadian Rhythm Sleep Disorder, Unspecified Type; Melatonin; Diabetic Retinopathy

Treatments: Drug: Melatonin 4 mg Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03478306

DR2

2015-003955-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

Arm 1

Active Comparator group

Description:

Melatonin, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.

Treatment:

Drug: Melatonin 4 mg Tablet

Arm 2

Placebo Comparator group

Description:

Place, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.

Treatment:

Drug: Melatonin 4 mg Tablet