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

NCT ID: NCT03478306

Last Updated: 2021-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-27
• Study Completion Date: 2021-06-12

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

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

Group Type: ACTIVE_COMPARATOR

Melatonin 4 mg Tablet

Intervention Type: DRUG

Participants are randomized into arm 1 or arm2, recieving melatonin or placebo, respectively, for 21 days, followed by 1 week of washout, and then swichting to the contralateral treatment arm.

Arm 2

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

Group Type: PLACEBO_COMPARATOR

Melatonin 4 mg Tablet

Intervention Type: DRUG

Participants are randomized into arm 1 or arm2, recieving melatonin or placebo, respectively, for 21 days, followed by 1 week of washout, and then swichting to the contralateral treatment arm.

Interventions

Melatonin 4 mg Tablet

Participants are randomized into arm 1 or arm2, recieving melatonin or placebo, respectively, for 21 days, followed by 1 week of washout, and then swichting to the contralateral treatment arm.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Shakoor Ba-Ali

Principal Investigator, Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shakoor Ba-Ali

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Rigshospitalet-Glostrup

Locations

Department of Ophthalmology, Rigshospitalet-Glostrup

Glostrup Municipality, RegionH, Denmark

Countries

Denmark

Other Identifiers

2015-003955-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DR2

Identifier Type: -

Identifier Source: org_study_id