NCT04547439RecruitingPhase 2
Sleep, Diabetic Retinopathy and Melatonin
Sleep and Circadian Regulation in Diabetic Retinopathy: The Role of Intrinsically Photosensitive Retinal Ganglion Cells and Melatonin Supplementation
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
This study explores the use of melatonin in patients with diabetic retinopathy
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 27 Jun 2020
- Start date
- 3 Feb 2021
- Primary completion date
- 2 Feb 2026
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Diabetic eye disease
- NCT number
- NCT04547439
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 42
- From 3 Feb 2021 to the primary completion date, 2 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- illicit drug use
- night shift work or travel beyond 2 time zones in the month before enrollment
Other illness
- end stage renal disease requiring renal replacement therapy
- history of stroke or transient ischemic attacks
- history of dementia or memory impairment
- uncontrolled congestive heart failure or recent hospitalization for cardiac condition (6 months)
- chronic obstructive pulmonary disease requiring oxygen
- severe chronic liver disease such as cirrhosis
- ongoing treatment for major medical problems such as cancer
- history of severe hypoglycemia defined as hypoglycemic episodes requiring assistance from others within the past six months.
- uncontrolled hypertension (blood pressure ≥ 160/100 mmHg),
- uncontrolled diabetes (A1C ≥ 11%),
- clinically significant epiretinal membranes, clinically significant lens opacities, or cystoid macular edema, iris neovascularization, iris atrophy, or an asymmetrically shaped pupil, nuclear sclerotic, posterior subcapsular, or cortical lens opacities greater than 2+, a history of pan-retinal photocoagulation.
Lab values
- abnormal liver function (AST or ALT\>3x upper limits of normal
- hemoglobin \<11.5 g/dL in women and \<13.5 g/dL in men.
Other
- use of melatonin
- antidepressants or antipsychotics
- Significant depressive symptoms
- untreated severe OSA (AHI≥ 30 events/hour),
- abnormal TSH
- use of sedatives and hypnotics.
Who the study is looking for
- Type 2 diabetes (clinically diagnosed, taking anti-diabetes medications or history of elevated A1C≥6.5%)
- 40-65 years of age
- Diabetic retinopathy of at least moderate degree
Age in the registry: 40 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.