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

NCT03478306 | Completed Phase 3 DMC

• 2 other identifiers: DR22015-003955-23
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression of diabetic retinopathy, oscillary potential

  Progression of diabetic retinopati measured with electroretinography

  3 weeks

Secondary Outcomes (3)

• Post-illumination pupillary light response

  3 weeks

• Circadian photoentrainment

  3 weeks

• Retinal structure

  3 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

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

Drug: Melatonin 4 mg Tablet

Arm 2

PLACEBO COMPARATOR

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

Drug: Melatonin 4 mg Tablet

Interventions

Melatonin 4 mg Tablet 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 1; Arm 2

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic patients
• Age range 40-75 years
• Participant should be legally competent

You may not qualify if:

• 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

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead
• Steno Diabetes Center Copenhagen: collaborator

Study Sites (1)

Department of Ophthalmology, Rigshospitalet-Glostrup

Glostrup Municipality, RegionH, 2600, Denmark

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Sleep Disorders, Circadian Rhythm

Interventions

Melatonin; Tablets

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Shakoor Ba-Ali

  Department of Ophthalmology, Rigshospitalet-Glostrup

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Melatonin and placebo tablets are identicle in terms of taste, colour, tablet-size etc. The tablets are packed and masked by external manufacturer.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor

Model Details: A Double-blind, randomized, placebo-controlled trial

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: March 27, 2018
• Primary Completion: June 12, 2021
• Study Completion: June 12, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)