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

Primary Purpose

Diabetic Retinopathy, Melatonin, Circadian Dysrhythmia

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Melatonin 4 mg Tablet
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Ophthalmology, Rigshospitalet-Glostrup

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Progression of diabetic retinopathy, oscillary potential
Progression of diabetic retinopati measured with electroretinography

Secondary Outcome Measures

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

Full Information

First Posted
March 20, 2018
Last Updated
July 30, 2021
Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
Steno Diabetes Center Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03478306
Brief Title
Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm
Official Title
Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
June 12, 2021 (Actual)
Study Completion Date
June 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
Steno Diabetes Center Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Melatonin, Circadian Dysrhythmia, Circadian Rhythm Sleep Disorder, Unspecified Type

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
A Double-blind, randomized, placebo-controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Melatonin and placebo tablets are identicle in terms of taste, colour, tablet-size etc. The tablets are packed and masked by external manufacturer.
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Melatonin, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Description
Place, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.
Intervention Type
Drug
Intervention Name(s)
Melatonin 4 mg Tablet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression of diabetic retinopathy, oscillary potential
Description
Progression of diabetic retinopati measured with electroretinography
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Post-illumination pupillary light response
Description
Melanopsin-mediated pupillary response
Time Frame
3 weeks
Title
Circadian photoentrainment
Description
Salivary melatonin level and sleep assessment
Time Frame
3 weeks
Title
Retinal structure
Description
Retinal structure assessed by optical coherence tomography
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shakoor Ba-Ali
Organizational Affiliation
Department of Ophthalmology, Rigshospitalet-Glostrup
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Rigshospitalet-Glostrup
City
Glostrup
State/Province
RegionH
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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