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

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:

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

Study Overview

• Status: Not yet recruiting
• Conditions: Visual Acuity; Central Serous Chorioretinopathy; Melatonin; Macula Abnormality; Ocular Diseases
• Intervention / Treatment: Drug: melatonin 3mg; Drug: Placebo Drug

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Mohsen Pourazizi; Phone Number: 98 + 09379578055; Email: m.pourazizi@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: melatonin 3mg; In this group, participants will be randomly assigned to take 3 mg tablets of melatonin twice a day for 1 month.
Placebo Comparator: 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
central macular thickness (CMT)	Changes in central macular thickness (CMT) in patients receiving oral melatonin versus patients receiving placebo	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	From enrollment to 3 months later

Collaborators and Investigators

• Sponsor: Mohsen Pourazizi
• Investigators: Study Director: Mohsen Pourazizi, Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Central Serous Chorioretinopathy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antioxidants; Protective Agents; Melatonin
• Other Study ID Numbers: IR.ARI.MUI.REC.1403.234

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No