Health TrialsbyHealthPanel

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

ConditionsCentral Serous ChorioretinopathyMelatoninOcular DiseasesVisual AcuityMacula Abnormality
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMohsen Pourazizi

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Case group: treatment with oral melatoninExperimental treatment 1 intervention
Group B: Placebo group: treatment with placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mohsen Pourazizi

Lead sponsor

Isfahan University of Medical Sciences

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: