Diabetic Retinopathy and Sleep disorder MedDRA version: 20.1 Level: PT Classification code 10012689 Term: Diabetic retinopathy System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Melatonin
Product Code: melatonin-DR2
Pharmaceutical Form: Tablet
INN or Proposed INN: Melatonin
CAS Number: 73-31-4
Other descriptive name: MELATONIN
Concentration unit: mg milligram(s)
Sponsors
Dept. of Ophthalmology, Rigshospitalet – Glostrup
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diabetic patients - Age range 40-75 years - Participant should be legally competent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
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. - Alkohol indtag under forsøgsperioden, da alkohol nedsætter melatonins søvnregulerende effekt.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: End of vist-5;Main Objective: To investigate the effects of melatonin treatment on visual functions and circadian rhythm in diabetic patients with or without diabetic retinopathy.;Secondary Objective: To investigate the effects of melatonin treatment on the circadian rhythm in diabetic patients with or without diabetic retinopathy.;Primary end point(s): Progression of diabetic retinopati measured with electroretinography (ERG). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Additional electroretinographic parameters: - Pupillometry Circadian photoentrainment incl. sleep: - Salivary melatonin level, sleep and activity measurement (Actigraphy) and sleep questionaires. Structurel retinal evaluation: - Retinal nerve fiber layer (RNFL) measured with Optical Coherence Tomography. - Fundusphotgraphy Functional retinal evaluation: - Visual acuity;Timepoint(s) of evaluation of this end point: End of visit-5 | — |
Countries
Denmark
Contacts
Public ContactReseach laboratory section 37
Dept. of Ophthalmology, Rigshospitalet – Glostrup
Outcome results
None listed