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

July 30, 2021 updated by: Shakoor Ba-Ali, Glostrup University Hospital, Copenhagen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • RegionH
      • Glostrup, RegionH, Denmark, 2600
        • Department of Ophthalmology, Rigshospitalet-Glostrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
Melatonin, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.
Drug: 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.
Placebo Comparator: Arm 2
Place, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of diabetic retinopathy, oscillary potential
Time Frame: 3 weeks
Progression of diabetic retinopati measured with electroretinography
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-illumination pupillary light response
Time Frame: 3 weeks
Melanopsin-mediated pupillary response
3 weeks
Circadian photoentrainment
Time Frame: 3 weeks
Salivary melatonin level and sleep assessment
3 weeks
Retinal structure
Time Frame: 3 weeks
Retinal structure assessed by optical coherence tomography
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glostrup University Hospital, Copenhagen

Collaborators

Steno Diabetes Center Copenhagen

Investigators

  • Principal Investigator: Shakoor Ba-Ali, Department of Ophthalmology, Rigshospitalet-Glostrup

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2018

Primary Completion (Actual)

June 12, 2021

Study Completion (Actual)

June 12, 2021

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

March 20, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR2
  • 2015-003955-23 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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