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

NCT06809751 | Not Yet Recruiting Phase 2

• 1 other identifier: IR.ARI.MUI.REC.1403.234
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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. 1.How does melatonin affect central macula thickness in CSCR?
2. 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.
3. 3.Take melatonin or placebo twice a day for one month
4. 4.Visit the clinic after finishing a course of treatment, and 1 and 3 months after that for visual acuity assessment and tests
5. 5.Keep a diary of their symptoms

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Case group: treatment with oral melatonin

EXPERIMENTAL

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

Placebo group: treatment with placebo

PLACEBO COMPARATOR

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

Interventions

melatonin 3mg DRUG

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

Case group: treatment with oral melatonin

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).

Placebo group: treatment with placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mohsen Pourazizi: lead

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Mohsen Pourazizi

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

  STUDY DIRECTOR

Central Study Contacts

Mohsen Pourazizi

CONTACT

98 + 09379578055; m.pourazizi@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-01