Central Serous ChorioretinopathyPhase 2/3NCT06809751
Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy
A Phase 2/3 study testing melatonin 3mg in people with Central Serous Chorioretinopathy and Melatonin, run by Mohsen Pourazizi.
Trial summary
The goal of this clinical trial is to learn if oral melatonin can enhance visual acuity and central macular thickness in central serous chorioretinopathy (CSCR) in adults. The main questions it aims to answer are: 1. How does melatonin affect central macula thickness in CSCR? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Serous Chorioretinopathy, Melatonin, Ocular Diseases
- What is being tested?
- melatonin 3mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Jun 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose diagnosis of central serous chorioretinopathy is confirmed based on clinical and imaging criteria within the past 6 weeks
- Patients with minimum age of 18 years old
- Consent to participate in the study
Who cannot join
- A history of vitrectomy
- A history of laser surgery in the eye being studied in the past 3 months
- A history of anti-VEGF injection in the eye being studied in the past 3 months
- History of patient suspicious for choroidal neovascularization (CNV)
- Pregnant or nursing patients
- Patients with significantly compromised visual acuity in the eye being studied due to concomitant ocular condition
- Patients participating in any other investigational drug study
- Inability to obtain OCT photographs
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy (CSCR): a Double-blind Randomized Clinical Trial
The goal of this clinical trial is to learn if oral melatonin can enhance visual acuity and central macular thickness in central serous chorioretinopathy (CSCR) in adults. The main questions it aims to answer are:
- How does melatonin affect central macula thickness in CSCR?
- How does melatonin affect visual acuity in CSCR? Researchers will compare placebo (a look-like substance that contains no drug) to see if melatonin works to treat CSCR.
Participants will:
- Take melatonin or placebo twice a day for one month
- Visit the clinic after finishing a course of treatment, and 1 and 3 months after that for visual acuity assessment and tests
- Keep a diary of their symptoms
- Conditions
- Central Serous Chorioretinopathy, Melatonin, Ocular Diseases, Visual Acuity, Macula Abnormality
- Being tested
- melatonin 3mg, Placebo Drug
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatonin 3mgDrug
In this group, participants will be randomly assigned to take 3 mg tablets of melatonin twice a day for 1 month.
Placebo DrugDrug
The placebo is also prepared in the form of tablets with similar packaging as melatonin by the pharmaceutical company. Participants will be randomly assigned to take placebo with the same frequency and duration as melatonin (twice a day for 1 month).
| Study group | Role | What they receive |
|---|---|---|
| Case group: treatment with oral melatonin | Experimental | In the case group, the patients with central serous chorioretinopathy will receive oral melatonin within one month and outcomes will be assessed after finishing the course of the treatment, and 1 and 3 months later. Receives: Drug: melatonin 3mg |
| Placebo group: treatment with placebo | Placebo comparator | In the placebo group, the patients with central serous chorioretinopathy will receive the placebo substance after finishing the course of the treatment, and 1 and 3 months later. Receives: Drug: Placebo Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
central macular thickness (CMT)
Changes in central macular thickness (CMT) in patients receiving oral melatonin versus patients receiving placebo
Measured: From enrollment to 3 month later
best visual acuity (BCVA)
Changes in best visual acuity (BCVA) in patients receiving oral melatonin versus patients receiving placebo
Measured: From enrollment to 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Serous ChorioretinopathyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohsen Pourazizi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohsen Pourazizi, Isfahan University of Medical Sciences
- Investigators
- Mohsen Pourazizi, Study director, Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809751
- Sponsor's protocol ID
- IR.ARI.MUI.REC.1403.234
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy (CSCR): a Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06809751
- Acronym / sponsor ID
- IR.ARI.MUI.REC.1403.234
- Conditions
- Central Serous Chorioretinopathy, Melatonin, Ocular Diseases, Visual Acuity, Macula Abnormality
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Mohsen PouraziziUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 5 Feb 2025 (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.
The goal of this clinical trial is to learn if oral melatonin can enhance visual acuity and central macular thickness in central serous chorioretinopathy (CSCR) in adults. The main questions it aims to answer are:
- How does melatonin affect central macula thickness in CSCR?
- How does melatonin affect visual acuity in CSCR? Researchers will compare placebo (a look-like substance that contains no drug) to see if melatonin works to treat CSCR.
Participants will:
- Take melatonin or placebo twice a day for one month
- Visit the clinic after finishing a course of treatment, and 1 and 3 months after that for visual acuity assessment and tests
- Keep a diary of their symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group: treatment with oral melatonin | Experimental | Drug: melatonin 3mgIn the case group, the patients with central serous chorioretinopathy will receive oral melatonin within one month and outcomes will be assessed after finishing the course of the treatment, and 1 and 3 months later. |
| Placebo group: treatment with placebo | Placebo comparator | Drug: Placebo DrugIn the placebo group, the patients with central serous chorioretinopathy will receive the placebo substance after finishing the course of the treatment, and 1 and 3 months later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients whose diagnosis of central serous chorioretinopathy is confirmed based on clinical and imaging criteria within the past 6 weeks
- Patients with minimum age of 18 years old
- Consent to participate in the study
Key exclusion criteria (8 listed)
- A history of vitrectomy
- A history of laser surgery in the eye being studied in the past 3 months
- A history of anti-VEGF injection in the eye being studied in the past 3 months
- History of patient suspicious for choroidal neovascularization (CNV)
- Pregnant or nursing patients
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 3mgIn this group, participants will be randomly assigned to take 3 mg tablets of melatonin twice a day for 1 month. | Drug | Case group: treatment with oral melatonin |
| Placebo DrugThe placebo is also prepared in the form of tablets with similar packaging as melatonin by the pharmaceutical company. Participants will be randomly assigned to take placebo with the same frequency and duration as melatonin (twice a day for 1 month). | Drug | Placebo group: treatment with placebo |
Primary outcome
central macular thickness (CMT)
Time frame: From enrollment to 3 month later
Changes in central macular thickness (CMT) in patients receiving oral melatonin versus patients receiving placebo
best visual acuity (BCVA)
Time frame: From enrollment to 3 months later
Changes in best visual acuity (BCVA) in patients receiving oral melatonin versus patients receiving placebo
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
Related trials for Central Serous Chorioretinopathy
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
Not yet recruiting
Mindfulness for Central Serous Chorioretinopathy
Central Serous Chorioretinopathy
RecruitingObservational study
Biomarkers and Choroidal Neovascularization
Choroidal Neovascularization, Mineralocorticoid Excess
Not yet recruitingPhase 2
Faricimab for Chronic Central Serous Chorioretinopathy: A Randomized Sham-Controlled Trial
Central Serous Chorioretinopathy (CSC)
Recruiting
the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy
Central Serous Chorioretinopathy
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.
Mohsen Pourazizi study director
Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing melatonin 3mg in people with Central Serous Chorioretinopathy and Melatonin, run by Mohsen Pourazizi.
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 8 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: opening soon, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohsen Pourazizi (98 + 09379578055, m.pourazizi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central macular thickness (CMT) (time frame: From enrollment to 3 month later). The study lists 2 primary outcomes in all. 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 5 Feb 2025.