Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy

NCT ID: NCT06809751

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-06-01

Brief 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. 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:

1. Take melatonin or placebo twice a day for one month

2. Visit the clinic after finishing a course of treatment, and 1 and 3 months after that for visual acuity assessment and tests

3. Keep a diary of their symptoms

Conditions

Central Serous Chorioretinopathy; Melatonin; Ocular Diseases; Visual Acuity; Macula Abnormality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Case group: treatment with oral melatonin

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.

Group Type: EXPERIMENTAL

melatonin 3mg

Intervention Type: DRUG

In this group, participants will be randomly assigned to take 3 mg tablets of melatonin twice a day for 1 month.

Placebo group: treatment with placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo Drug

Intervention Type: DRUG

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).

Interventions

melatonin 3mg

In this group, participants will be randomly assigned to take 3 mg tablets of melatonin twice a day for 1 month.

Intervention Type: DRUG

Placebo Drug

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients whose diagnosis of central serous chorioretinopathy is confirmed based on clinical and imaging criteria within the past 6 weeks

2. Patients with minimum age of 18 years old

3. Consent to participate in the study

Exclusion Criteria

1. A history of vitrectomy

2. A history of laser surgery in the eye being studied in the past 3 months

3. A history of anti-VEGF injection in the eye being studied in the past 3 months

4. History of patient suspicious for choroidal neovascularization (CNV)

5. Pregnant or nursing patients

6. Patients with significantly compromised visual acuity in the eye being studied due to concomitant ocular condition

7. Patients participating in any other investigational drug study

8. Inability to obtain OCT photographs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mohsen Pourazizi

OTHER

Sponsor Role: lead

Responsible Party

Mohsen Pourazizi

Assistant Professor of Ophthalmology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mohsen Pourazizi

Role: STUDY_DIRECTOR

Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran

Central Contacts

Mohsen Pourazizi

Role: CONTACT

m.pourazizi@yahoo.com

98 + 09379578055

Other Identifiers

IR.ARI.MUI.REC.1403.234

Identifier Type: -

Identifier Source: org_study_id