Status:
COMPLETED
Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm
Lead Sponsor:
Glostrup University Hospital, Copenhagen
Collaborating Sponsors:
Steno Diabetes Center Copenhagen
Conditions:
Diabetic Retinopathy
Melatonin
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
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 wil...
Eligibility Criteria
Inclusion
- Diabetic patients
- Age range 40-75 years
- Participant should be legally competent
Exclusion
- 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
Key Trial Info
Start Date :
March 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03478306
Start Date
March 27 2018
End Date
June 12 2021
Last Update
August 2 2021
Active Locations (1)
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1
Department of Ophthalmology, Rigshospitalet-Glostrup
Glostrup Municipality, RegionH, Denmark, 2600