Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-01-16 @ 8:49 AM
Study NCT ID:
NCT03226951
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2017-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SDM Laser for Non Central Diabetic CSME
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-25', 'studyFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2017-07-20', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of eyes with reduced macular thickness', 'timeFrame': '24 weeks', 'description': 'Measurements of retinal thickness in the area of edema'}], 'secondaryOutcomes': [{'measure': 'Number of eyes with reduced vision', 'timeFrame': '24 weeks', 'description': 'Best corrected visual acuity at the end of the study'}, {'measure': 'Number of eyes developing central macular edema', 'timeFrame': '24 weeks'}, {'measure': 'Number of patients achieved good glycemic control', 'timeFrame': '24 weeks', 'description': 'By measuring HbA1C every 12 weeks from baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Central Diabetic Macular Edema']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Marashi A. Non-central diabetic clinical significant macular edema treatment with 532nm sub threshold laser. Adv Ophthalmol Vis Syst. 2018;8(3):151-154. DOI: 10.15406/aovs.2018.08.0029'}], 'seeAlsoLinks': [{'url': 'http://medcraveonline.com/AOVS/AOVS-08-00291.pdf', 'label': 'Non-central diabetic clinical significant macular edema treatment with 532nm sub threshold laser'}]}, 'descriptionModule': {'briefSummary': 'Is to determine if SDM laser can reduce macular thickness in non central CSME and stop the progression of non central CSME to central CSME in compare to glycemic control', 'detailedDescription': 'interventional randomised masked study will recruit patients have diabetes mellitus with non central CSME with good vision into two groups : 1st SDM laser with glycemic control 2nd SHAM laser with Glycemic control where BCVA will be recorded every month starting from baseline to 24 weeks where OCT will be recorded every 8 weeks from baseline to 24 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with central diabetic macular edema Best corrected visual acuity is 20/30 or more\n* Non central Macular thickness more than 250 microns\n* Patients who are able to come for all follow-up\n\nExclusion Criteria:\n\n* Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.\n* Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization\n* For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.\n* Macular edema is present that is considered to be related to ocular surgery such as cataract extraction\n* Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more\n* History of major ocular surgery (including vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.\n* Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis'}, 'identificationModule': {'nctId': 'NCT03226951', 'briefTitle': 'SDM Laser for Non Central Diabetic CSME', 'organization': {'class': 'OTHER', 'fullName': 'Marashi Eye Clinic'}, 'officialTitle': 'Sub Threshold Laser for Non Central Diabetic Clinical Significant Macular Edema', 'orgStudyIdInfo': {'id': 'Protocol DME 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subtherhold 532 nm laser', 'description': 'Applying 532nm subtherhold laser with 5% duty cycle using high density low intensity protocol at the area of non central clinical significant macular edema', 'interventionNames': ['Device: Subthreshold 532nm laser']}], 'interventions': [{'name': 'Subthreshold 532nm laser', 'type': 'DEVICE', 'description': 'Subthershold 532nm laser', 'armGroupLabels': ['Subtherhold 532 nm laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2241511', 'city': 'Aleppo', 'country': 'Syria', 'facility': 'Marashi Eye Clinic', 'geoPoint': {'lat': 36.20124, 'lon': 37.16117}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marashi Eye Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Ameen Marashi', 'investigatorAffiliation': 'Marashi Eye Clinic'}}}}