NCT03478306

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

Completed Phase 3 Last updated 2 August 2021

What this trial tests

Phase 3 trial testing Melatonin 4 mg Tablet in Diabetic Retinopathy in 31 participants. Completed in 12 June 2021.

Timeline

27 March 2018

Primary endpoint
12 June 2021

12 June 2021

Quick facts

Lead sponsor	Glostrup University Hospital, Copenhagen
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	31
Start date	27 March 2018
Primary completion	12 June 2021
Estimated completion	12 June 2021
Sites	1 location across Denmark

Drugs / interventions tested

• Melatonin 4 mg Tablet

Conditions studied

• Diabetic Retinopathy — all drugs for Diabetic Retinopathy →
• Melatonin — all drugs for Melatonin →
• Circadian Dysrhythmia — all drugs for Circadian Dysrhythmia →
• Circadian Rhythm Sleep Disorder, Unspecified Type — all drugs for Circadian Rhythm Sleep Disorder, Unspecified Type →

Sponsor

Glostrup University Hospital, Copenhagen

Who can join

Adults 40 to 75, any sex, with Diabetic Retinopathy or Melatonin. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microglia in retinal angiogenesis and diabetic retinopathy.
   Hu A, Schmidt MHH, Heinig N. · · 2024 · cited 54× · PMID 38564108 · DOI 10.1007/s10456-024-09911-1
2. Emerging Insights and Interventions for Diabetic Retinopathy.
   Honasoge A, Nudleman E, Smith M, Rajagopal R. · · 2019 · cited 32× · PMID 31506830 · DOI 10.1007/s11892-019-1218-2
3. Inherited Retinal Dystrophies: Role of Oxidative Stress and Inflammation in Their Physiopathology and Therapeutic Implications.
   Pinilla I, Maneu V, Campello L, Fernández-Sánchez L, et al · · 2022 · cited 30× · PMID 35739983 · DOI 10.3390/antiox11061086
4. Therapeutic Effects of Melatonin on Ocular Diseases: Knowledge Map and Perspective.
   Yu H, Wang Q, Wu W, Zeng W, et al · · 2021 · cited 16× · PMID 34795578 · DOI 10.3389/fphar.2021.721869
5. Circadian rhythms in diabetic retinopathy: an overview of pathogenesis and investigational drugs.
   Bhatwadekar AD, Rameswara V. · · 2020 · cited 14× · PMID 33107770 · DOI 10.1080/13543784.2020.1842872
6. Circadian clocks and their role in kidney and eye diseases across organ systems.
   Chen X, Zhang W, Gu Y, Huang S. · · 2025 · cited 3× · PMID 40496242 · DOI 10.3389/fphys.2025.1583502