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

Phase 3Not Yet RecruitingNCT06809751

Mohsen Pourazizi48 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Central Serous Chorioretinopathy Melatonin Ocular Diseases Visual Acuity

Interventions

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

central macular thickness (CMT)

Changes in central macular thickness (CMT) in patients receiving oral melatonin versus patients receiving placebo

Time frame: 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

Time frame: From enrollment to 3 months later