Examination of day-night cycle and the effect of medication with the neurohormone melatonin on visual functions in patients with diabetic retinopathy

Phase 1

• Conditions: Diabetic Retinopathy and Sleep disorder; MedDRA version: 20.1Level: PTClassification code 10012689Term: Diabetic retinopathySystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2015-003955-23-DK
• Lead Sponsor: Dept. of Ophthalmology, Rigshospitalet – Glostrup

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-18
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Additional electroretinographic parameters: <br>- Pupillometry<br><br>Circadian photoentrainment incl. sleep: <br>- Salivary melatonin level, sleep and activity measurement (Actigraphy) and sleep questionaires. <br><br>Structurel retinal evaluation: <br>- Retinal nerve fiber layer (RNFL) measured with Optical Coherence Tomography.<br>- Fundusphotgraphy <br><br>Functional retinal evaluation: <br>- Visual acuity;Timepoint(s) of evaluation of this end point: End of visit-5