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

Phase 2

Not yet recruiting

• Conditions: Central Serous Chorioretinopathy; Melatonin; Ocular Diseases; Visual Acuity; Macula Abnormality
• Interventions: Drug: melatonin 3mg; Drug: Placebo Drug

• Registration Number: NCT06809751
• Lead Sponsor: Mohsen Pourazizi

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Study Start: 2025-02-01
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-05-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case group: treatment with oral melatonin	melatonin 3mg	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.
Placebo group: treatment with placebo	Placebo Drug	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.

Primary Outcome Measures

Name	Time	Method
central macular thickness (CMT)	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)	From enrollment to 3 months later	Changes in best visual acuity (BCVA) in patients receiving oral melatonin versus patients receiving placebo