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Melatonin for Diabetic Retinopathy

Phase 2
Recruiting
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diabetic retinopathy of at least moderate degree
Type 2 diabetes (clinically diagnosed, taking anti-diabetes medications or history of elevated A1C≥6.5%)
Must not have
History of stroke or transient ischemic attacks
Use of melatonin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours

Summary

This trial looks at whether melatonin can help improve symptoms in patients with diabetic retinopathy.

Who is the study for?
This trial is for people aged 40-65 with Type 2 diabetes and moderate diabetic retinopathy. Candidates must not have severe memory issues, major untreated diseases like cancer or heart failure, uncontrolled blood pressure or diabetes, recent severe hypoglycemia, certain eye conditions, or be using melatonin or specific psychiatric drugs.
What is being tested?
The study tests if melatonin can help patients with diabetic retinopathy. Participants will either receive melatonin or a placebo (a substance with no active drug). The goal is to see if there's any improvement in their condition compared to those who don't take the real medication.
What are the potential side effects?
While the side effects of melatonin are generally mild and may include drowsiness, headache, dizziness, or nausea; this trial will monitor participants closely for any unexpected reactions due to their specific health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have moderate or worse diabetic eye disease.
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I have type 2 diabetes or my A1C level is 6.5% or higher.
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I am between 40 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a stroke or a mini-stroke before.
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I am currently taking melatonin.
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I am currently receiving treatment for a major medical condition.
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I am on dialysis for end-stage kidney disease.
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I am experiencing severe depression.
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My diabetes is not under control, with an A1C level of 11% or higher.
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I have significant eye conditions, including vision-impairing membranes or lens issues.
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I need oxygen for my chronic lung condition.
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My hemoglobin level is below the normal range for my gender.
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I have severe liver disease, like cirrhosis.
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I am taking antidepressants or antipsychotics.
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I have severe sleep apnea not yet treated.
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My liver tests are more than three times the normal limit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Melatonin and Cortisol Rhythm
Sleep pattern

Trial Design

2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Placebo
Group II: MelatoninActive Control1 Intervention
Melatonin

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
638 Previous Clinical Trials
1,569,093 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
30 Patients Enrolled for Diabetic Retinopathy
University of ChicagoOTHER
1,050 Previous Clinical Trials
759,003 Total Patients Enrolled

Media Library

Diabetic Retinopathy Research Study Groups: Control, Melatonin
~8 spots leftby Dec 2025
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