Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-02 @ 1:51 AM
Study NCT ID:
NCT04895293
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2021-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
RBM-007 in Treatment naïve Exudative Age-related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maturi.md@midwesteye.com', 'phone': '317-817-1423', 'title': 'Raj K. Maturi, M.D.', 'organization': 'Midwest Eye Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'All adverse events and serious adverse events were continually assessed throughout the study. The investigator assessed safety throughout the study to determine appropriateness of continuing dosing and enrollment.', 'eventGroups': [{'id': 'EG000', 'title': 'RBM-007 Injectable Solution - 2.0 mg', 'description': 'Single intravitreal injection in study eye\n\nRBM-007 Injectable Solution: Sterile solution', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Positive COVID test', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Subretinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction (mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea (severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Macular Edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RBM-007 Injectable Solution - 2.0 mg', 'description': 'Single intravitreal injection in study eye\n\nRBM-007 Injectable Solution: Sterile solution'}], 'classes': [{'categories': [{'measurements': [{'value': '416', 'groupId': 'OG000', 'lowerLimit': '257', 'upperLimit': '648'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Central subfield thickness on optical coherence tomography', 'unitOfMeasure': 'Microns', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RBM-007 Injectable Solution - 2.0 mg', 'description': 'Single intravitreal injection in study eye\n\nRBM-007 Injectable Solution: Sterile solution'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '77'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 Months', 'description': 'Change from Baseline in Best Corrected Visual Acuity', 'unitOfMeasure': 'Letters seen on eye chart', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RBM-007 Injectable Solution - 2.0 mg', 'description': 'Single intravitreal injection in study eye\n\nRBM-007 Injectable Solution: Sterile solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'RBM-007 Injectable Solution - 2.0 mg', 'description': 'Single intravitreal injection in study eye\n\nRBM-007 Injectable Solution: Sterile solution'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Visual Acuity', 'classes': [{'categories': [{'measurements': [{'value': '66.6', 'groupId': 'BG000', 'lowerLimit': '57', 'upperLimit': '73'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Letters seen on eye chart', 'dispersionType': 'FULL_RANGE'}, {'title': 'Central subfield thickness', 'classes': [{'categories': [{'measurements': [{'value': '422.8', 'groupId': 'BG000', 'lowerLimit': '350', 'upperLimit': '579'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Microns', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-11', 'size': 416414, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-20T10:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All subjects receive the study treatment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2021-05-17', 'resultsFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2021-05-17', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-20', 'studyFirstPostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Macular Edema', 'timeFrame': '3 months', 'description': 'Central subfield thickness on optical coherence tomography'}], 'secondaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': '3 Months', 'description': 'Change from Baseline in Best Corrected Visual Acuity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This study is a single-center, open label, 4-month study, designed to evaluate the safety and treatment efficacy of RBM-007 in patients with intraretinal or subretinal edema due to previously untreated neovascular AMD. Up to 5 subjects will be randomized to receive study medication. Study treatment will be administered by intravitreal injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• General Inclusion Criteria:\n\n1. Male or female patients, 50 years of age or older at baseline\n2. Patient has completed/signed an informed consent prior to any study-related procedures and is able to follow study instructions and likely to complete all required visits.\n\n • Ocular Inclusion Criteria:\n3. Best Corrected Visual Acuity (BCVA) 5 - 73 ETDRS letters (20/800-20/40 Snellen equivalent), inclusive, in study eye\n4. Presence of choroidal neovascularization secondary to AMD\n5. Clear ocular media and adequate pupil dilation to permit good quality photographic imaging.\n\nExclusion Criteria:\n\n• General Exclusion Criteria:\n\n1. Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.\n2. History or current evidence of hypersensitivity to any components of the study medication or fluorescein, as assessed by the investigator.\n3. Participation in any investigational drug or device study within 30 days prior to baseline\n4. History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study.\n\n • Ocular Exclusion Criteria:\n5. Active ocular or periocular infections, malignancy\n6. Aphakia\n7. History of pars plana vitrectomy in the study eye\n8. History of major ophthalmic surgery in the past 3 months in the study eye, or minor surgery in the past 30 days\n9. History of significant ocular disease other than exudative AMD that may confound results\n10. Uncontrolled glaucoma (defined as intraocular pressure \\>21mm Hg despite treatment with ocular hypotensive medications at baseline).'}, 'identificationModule': {'nctId': 'NCT04895293', 'acronym': 'TEMPURA', 'briefTitle': 'RBM-007 in Treatment naïve Exudative Age-related Macular Degeneration', 'organization': {'class': 'INDIV', 'fullName': 'Maturi, Raj K., M.D., P.C.'}, 'officialTitle': 'Evaluation of RBM-007 in Subjects With Treatment naïve Exudative Age-related Macular Degeneration (AMD)', 'orgStudyIdInfo': {'id': 'RKM-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RBM-007 Injectable Solution - 2.0 mg', 'description': 'Single intravitreal injection in study eye', 'interventionNames': ['Drug: RBM-007 Injectable Solution']}], 'interventions': [{'name': 'RBM-007 Injectable Solution', 'type': 'DRUG', 'description': 'Sterile solution', 'armGroupLabels': ['RBM-007 Injectable Solution - 2.0 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46290', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Eye Institute', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Raj K. Maturi, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Midwest Eye Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maturi, Raj K., M.D., P.C.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}