Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT03606733
Status:
UNKNOWN
Last Update Posted:
2018-10-29
First Post:
2018-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Retinal Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bulgaria', 'India']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D015866', 'term': 'Uveitis, Posterior'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Injection of triamcinilone or/ and VEGF blockade agents in the Supra Choroidal Space'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-25', 'studyFirstSubmitDate': '2018-07-22', 'studyFirstSubmitQcDate': '2018-07-27', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients achieved visual acuity improvement', 'timeFrame': '12 weeks', 'description': 'To measure best corrected visual acuity using using Snellen chart or equivalent'}], 'secondaryOutcomes': [{'measure': 'Amount of Central macular thickness reduction in microns', 'timeFrame': '12 weeks', 'description': 'Using optical coherence tomography in monthly bases to measure central retinal thickness'}, {'measure': 'Proportion of eyes with Increased intraocular pressure', 'timeFrame': '12 weeks', 'description': 'To measure intraocular pressure using Goldmann applanation tonometer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Marashi A. Treating macular edema secondary to retinal vein occlusion with suprachoroidal injection of triamcinolone acetonide using custom made needle. Adv Ophthalmol Vis Syst. 2018;8(5):277-281. DOI: 10.15406/aovs.2018.08.00321'}], 'seeAlsoLinks': [{'url': 'http://medcraveonline.com/AOVS/AOVS-08-00321.pdf', 'label': 'Treating macular edema secondary to retinal vein occlusion with suprachoroidal injection of triamcinolone acetonide using custom made needle'}]}, 'descriptionModule': {'briefSummary': 'Injection in the Suprachoroidal space has potential of increasing the efficacy of the drug upto six times with direct effect on retinal tissues sparing the crystalline lens and trabecular meshwork.', 'detailedDescription': 'A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana with the help of gentle pressure on the sclera will help to inject medication such as triamcinilone or VEGF blockade agents (Ziv aflibercept or Bevacizumab) in the potential Suprachoroidal space which offers direct effect of injected drug on the retina and choroid sparing both crystalline lens, trabecular meshwork and other ocular tissues, hence improving efficacy of the drug upto six times and reduce potential complications such as cataract and glaucoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 years and older\n* Patients with macular edema or degeneration from various pathologies\n* 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* Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis'}, 'identificationModule': {'nctId': 'NCT03606733', 'briefTitle': 'Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Retinal Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Marashi Eye Clinic'}, 'officialTitle': 'Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Macular Diseases and Non Infectious Posterior Uveitis', 'orgStudyIdInfo': {'id': 'SCS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A custom made Suprachoroidal needle for macular diseases', 'description': 'A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana', 'interventionNames': ['Procedure: Custom suorachoroidal needle']}], 'interventions': [{'name': 'Custom suorachoroidal needle', 'type': 'PROCEDURE', 'description': 'Custom made Supra Choroidal Space needle', 'armGroupLabels': ['A custom made Suprachoroidal needle for macular diseases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2241511', 'city': 'Aleppo', 'status': 'RECRUITING', 'country': 'Syria', 'contacts': [{'name': 'Ameen Marashi, MD', 'role': 'CONTACT', 'email': 'ameenmarashi@hotmail.com', 'phone': '963212241511'}], 'facility': 'Marashi Eye Clinic', 'geoPoint': {'lat': 36.20124, 'lon': 37.16117}}], 'centralContacts': [{'name': 'Ameen Marashi', 'role': 'CONTACT', 'email': 'ameenmarashi@hotmail.com', 'phone': '963937785557'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marashi Eye Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Ameen Marashi', 'investigatorAffiliation': 'Marashi Eye Clinic'}}}}