Diabetic RetinopathyPhase 3NCT03478306
Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm
A Phase 3 study testing Melatonin 4 mg Tablet in people with Diabetic Retinopathy and Melatonin, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetic Retinopathy, Melatonin, Circadian Dysrhythmia
- What is being tested?
- Melatonin 4 mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Mar 2018to 12 Jun 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic patients
- Age range 40-75 years
- Participant should be legally competent
Who cannot join
- 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
Show all 13Show fewer
- 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.
- Alcohol consumption during treatment
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology, Rigshospitalet-Glostrup
Glostrup Municipality, RegionH, 2600
About this study
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.
- Conditions
- Diabetic Retinopathy, Melatonin, Circadian Dysrhythmia, Circadian Rhythm Sleep Disorder, Unspecified Type
- Being tested
- Melatonin 4 mg Tablet
- Medical subject headings
- Diabetic Retinopathy, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 4 mg TabletDrug
Participants are randomized into arm 1 or arm2, recieving melatonin or placebo, respectively, for 21 days, followed by 1 week of washout, and then swichting to the contralateral treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Melatonin, 1 tablet (4 mg), every evening 2 hours before bed in 21 days. Receives: Drug: Melatonin 4 mg Tablet |
| Arm 2 | Placebo comparator | Place, 1 tablet (4 mg), every evening 2 hours before bed in 21 days. Receives: Drug: Melatonin 4 mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of diabetic retinopathy, oscillary potential
Progression of diabetic retinopati measured with electroretinography
Measured: 3 weeks
Secondary outcomes (3)
Post-illumination pupillary light response
Melanopsin-mediated pupillary response
Measured: 3 weeks
Circadian photoentrainment
Salivary melatonin level and sleep assessment
Measured: 3 weeks
Retinal structure
Retinal structure assessed by optical coherence tomography
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start27 Mar 2018
- Primary completion12 Jun 2021
- Study completion12 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A Double-blind, randomized, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen
- Responsible party
- Principal investigator, Shakoor Ba-Ali, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Shakoor Ba-Ali, Principal investigator, Department of Ophthalmology, Rigshospitalet-Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478306
- Sponsor's protocol ID
- DR2
- Other IDs
- 2015-003955-23, 2015
- Status last verified
- Jul 2021
- First submitted
- 20 Mar 2018
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm
- ClinicalTrials.gov ID
- NCT03478306
- Acronym / sponsor ID
- DR2
- Conditions
- Diabetic Retinopathy, Melatonin, Circadian Dysrhythmia, Circadian Rhythm Sleep Disorder, Unspecified Type
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 12 Jun 2021 (actual)
- Study completion
- 12 Jun 2021 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Double-blind, randomized, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Melatonin 4 mg TabletMelatonin, 1 tablet (4 mg), every evening 2 hours before bed in 21 days. |
| Arm 2 | Placebo comparator | Drug: Melatonin 4 mg TabletPlace, 1 tablet (4 mg), every evening 2 hours before bed in 21 days. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetic patients
- Age range 40-75 years
- Participant should be legally competent
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 4 mg TabletParticipants are randomized into arm 1 or arm2, recieving melatonin or placebo, respectively, for 21 days, followed by 1 week of washout, and then swichting to the contralateral treatment arm. | Drug | Arm 1, Arm 2 |
Primary outcome
Progression of diabetic retinopathy, oscillary potential
Time frame: 3 weeks
Progression of diabetic retinopati measured with electroretinography
3 secondary outcomes
Post-illumination pupillary light response
Time frame: 3 weeks
Circadian photoentrainment
Time frame: 3 weeks
Retinal structure
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shakoor Ba-Ali principal investigator
Department of Ophthalmology, Rigshospitalet-Glostrup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melatonin 4 mg Tablet in people with Diabetic Retinopathy and Melatonin, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of diabetic retinopathy, oscillary potential (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.