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

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

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Key information

Conditions

Central Serous Chorioretinopathy Eye Diseases Macula Abnormality Melatonin Ocular Diseases Retinal Diseases Visual Acuity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

melatonin 3mg

Drug

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

Placebo drug

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).

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohsen Pourazizi

CONTACT

[email protected]

98 + 09379578055

Sponsors and collaborators

Lead sponsor

Mohsen Pourazizi

Other

Registry information

Official study title

Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy (CSCR): a Double-blind Randomized Clinical Trial

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Feb 5, 2025
Registry last updated: Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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