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

G

Glostrup University Hospital, Copenhagen

Status and phase

Completed
Phase 3

Conditions

Circadian Dysrhythmia
Circadian Rhythm Sleep Disorder, Unspecified Type
Melatonin
Diabetic Retinopathy

Treatments

Drug: Melatonin 4 mg Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT03478306
DR2
2015-003955-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

31 participants in 2 patient groups, including a placebo group

Arm 1
Active Comparator group
Description:
Melatonin, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.
Treatment:
Drug: Melatonin 4 mg Tablet
Arm 2
Placebo Comparator group
Description:
Place, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.
Treatment:
Drug: Melatonin 4 mg Tablet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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