Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT06809751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-05
First Post:
2025-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056833', 'term': 'Central Serous Chorioretinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2025-01-30', 'studyFirstSubmitQcDate': '2025-01-30', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'central macular thickness (CMT)', 'timeFrame': 'From enrollment to 3 month later', 'description': 'Changes in central macular thickness (CMT) in patients receiving oral melatonin versus patients receiving placebo'}, {'measure': 'best visual acuity (BCVA)', 'timeFrame': 'From enrollment to 3 months later', 'description': 'Changes in best visual acuity (BCVA) in patients receiving oral melatonin versus patients receiving placebo'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Serous Chorioretinopathy', 'Melatonin', 'Ocular Diseases', 'Visual Acuity', 'Macula Abnormality']}, 'descriptionModule': {'briefSummary': '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:\n\n1. How does melatonin affect central macula thickness in CSCR?\n2. 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.\n\nParticipants will:\n\n1. Take melatonin or placebo twice a day for one month\n2. Visit the clinic after finishing a course of treatment, and 1 and 3 months after that for visual acuity assessment and tests\n3. Keep a diary of their symptoms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients whose diagnosis of central serous chorioretinopathy is confirmed based on clinical and imaging criteria within the past 6 weeks\n2. Patients with minimum age of 18 years old\n3. Consent to participate in the study\n\nExclusion Criteria:\n\n1. A history of vitrectomy\n2. A history of laser surgery in the eye being studied in the past 3 months\n3. A history of anti-VEGF injection in the eye being studied in the past 3 months\n4. History of patient suspicious for choroidal neovascularization (CNV)\n5. Pregnant or nursing patients\n6. Patients with significantly compromised visual acuity in the eye being studied due to concomitant ocular condition\n7. Patients participating in any other investigational drug study\n8. Inability to obtain OCT photographs'}, 'identificationModule': {'nctId': 'NCT06809751', 'briefTitle': 'Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy (CSCR): a Double-blind Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'IR.ARI.MUI.REC.1403.234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Case group: treatment with oral melatonin', 'description': '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.', 'interventionNames': ['Drug: melatonin 3mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group: treatment with placebo', 'description': '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.', 'interventionNames': ['Drug: Placebo Drug']}], 'interventions': [{'name': 'melatonin 3mg', 'type': 'DRUG', 'description': 'In this group, participants will be randomly assigned to take 3 mg tablets of melatonin twice a day for 1 month.', 'armGroupLabels': ['Case group: treatment with oral melatonin']}, {'name': 'Placebo Drug', 'type': 'DRUG', 'description': '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).', 'armGroupLabels': ['Placebo group: treatment with placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohsen Pourazizi', 'role': 'CONTACT', 'email': 'm.pourazizi@yahoo.com', 'phone': '98 + 09379578055'}], 'overallOfficials': [{'name': 'Mohsen Pourazizi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohsen Pourazizi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Ophthalmology', 'investigatorFullName': 'Mohsen Pourazizi', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}