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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478306
• Other study ID #: DR2
• Secondary ID: 2015-003955-23
• Status: Completed
• Phase: Phase 3
• Start date: March 27, 2018
• Est. completion date: June 12, 2021

Study information

• Verified date: July 2021
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 12, 2021
• Est. primary completion date: June 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Circadian Dysrhythmia
• Circadian Rhythm Sleep Disorder, Unspecified Type
• Diabetic Retinopathy
• Melatonin
• Parasomnias
• Retinal Diseases
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Ophthalmology, Rigshospitalet-Glostrup	Glostrup	RegionH

Sponsors (2)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of diabetic retinopathy, oscillary potential	Progression of diabetic retinopati measured with electroretinography	3 weeks
Secondary	Post-illumination pupillary light response	Melanopsin-mediated pupillary response	3 weeks
Secondary	Circadian photoentrainment	Salivary melatonin level and sleep assessment	3 weeks
Secondary	Retinal structure	Retinal structure assessed by optical coherence tomography	3 weeks