Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-03-13 @ 5:34 PM
Study NCT ID:
NCT03197493
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2017-06-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Extension, Carbidopa-levodopa in Neovascular Age-related Macular Degeneration (AMD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C009265', 'term': 'carbidopa, levodopa drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rsnyder781@gmail.com', 'phone': '5206616516', 'title': 'Dr. Robert W. Snyder', 'organization': 'Robert W Snyder, MD, PhD, PC'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The major limitations of our study include the small sample size and limited patient racial diversity.'}}, 'adverseEventsModule': {'timeFrame': 'From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study (visit 12), a maximum of 9 months following a 3 month enrollment in NCT03023059. A total of 9 months.', 'eventGroups': [{'id': 'EG000', 'title': 'High Dose', 'description': 'carbidopa-levodopa 25-100 mg 2 tablets TID\n\ncarbidopa-levodopa 25-100 mg: High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 3, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chest pain due to torn chest muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Best Corrected Visual Acuity by ETDRS Visual Scale Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose', 'description': 'carbidopa-levodopa 25-100 mg 2 tablets TID\n\ncarbidopa-levodopa 25-100 mg: High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '1.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study (visit 12), a maximum of 9 months following a 3 month enrollment in NCT03023059.', 'description': "This outcome is a measure of letters correctly identified using an Early Treatment Diabetic Retinopathy Study chart. The higher the number of letters identified, the better the participant's visual acuity.", 'unitOfMeasure': 'Change in letters (BCVA)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This population includes participants who completed NCT03022318 (naive to anti-VEGF injections at the time of enrollment) and patients who did not complete NCT03022318 but had been exposed to anti-VEGF injections before study initiation.'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Experienced', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose', 'description': 'carbidopa-levodopa 25-100 mg 2 tablets TID\n\ncarbidopa-levodopa 25-100 mg: High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Monthly for 9 months', 'description': 'Adverse events elicited by nonspecific questioning', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This population includes participants who completed NCT03022318 (naive to anti-VEGF injections at the time of enrollment) and patients who did not complete NCT03022318 but had been exposed to anti-VEGF injections before study initiation.'}, {'type': 'SECONDARY', 'title': 'Change in Central Retinal (Macular) Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose', 'description': 'carbidopa-levodopa 25-100 mg 2 tablets TID\n\ncarbidopa-levodopa 25-100 mg: High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.0', 'spread': '17.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study, a maximum of 9 months.', 'description': 'Central retinal thickness (in microns) is measured by spectral domain-optical coherence tomography. An increase in retinal thickness is associated with disease progression. A negative value represents a decrease in retinal thickness and therefore a positive clinical outcome measure.', 'unitOfMeasure': 'microns', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This population includes participants who completed NCT03022318 (naive to anti-VEGF injections at the time of enrollment) and patients who did not complete NCT03022318 but had been exposed to anti-VEGF injections before study initiation.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Retinal Fluid From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose', 'description': 'carbidopa-levodopa 25-100 mg 2 tablets TID\n\ncarbidopa-levodopa 25-100 mg: High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.8', 'spread': '24.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study, (visit 10), a maximum of 9 months.', 'description': 'Retinal fluid changes on direct retinal examination on spectral domain - optical coherence tomography. Changes in retinal fluid were compared to baseline values. A negative percentage point represents a decrease in retinal fluid and therefore a positive clinical outcome.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This population includes participants who completed NCT03022318 (naive to anti-VEGF injections at the time of enrollment) and patients who did not complete NCT03022318 but had been exposed to anti-VEGF injections before study initiation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Carbidopa/Levodopa High Dose', 'description': 'carbidopa-levodopa 25-100 mg 2 tablets TID\n\ncarbidopa-levodopa 25-100 mg: High Dose: daily oral administration 2 tablets TID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Carbidopa/Levodopa High Dose', 'description': 'carbidopa-levodopa 25-100 mg 2 tablets TID\n\ncarbidopa-levodopa 25-100 mg: High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000', 'lowerLimit': '58', 'upperLimit': '87'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Patients naive to anti-VEGF injections at start of study', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This population includes participants who completed NCT03022318 (naive to anti-VEGF injections at the time of enrollment) and patients who did not complete NCT03022318 but had been exposed to anti-VEGF injections before study initiation.'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2017-06-24', 'size': 249588, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-08T18:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients who complete 3 months of escalation dose carbidopa-levodopa, will receive 9 additional months of therapy with the highest dose used in protocol 0002, carbidopa-levodopa 25-100 mg 2 tablets TID.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2017-06-19', 'resultsFirstSubmitDate': '2024-07-12', 'studyFirstSubmitQcDate': '2017-06-21', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-10', 'studyFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Best Corrected Visual Acuity by ETDRS Visual Scale Testing', 'timeFrame': 'From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study (visit 12), a maximum of 9 months following a 3 month enrollment in NCT03023059.', 'description': "This outcome is a measure of letters correctly identified using an Early Treatment Diabetic Retinopathy Study chart. The higher the number of letters identified, the better the participant's visual acuity."}], 'secondaryOutcomes': [{'measure': 'Number of Adverse Events Experienced', 'timeFrame': 'Monthly for 9 months', 'description': 'Adverse events elicited by nonspecific questioning'}, {'measure': 'Change in Central Retinal (Macular) Thickness', 'timeFrame': 'From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study, a maximum of 9 months.', 'description': 'Central retinal thickness (in microns) is measured by spectral domain-optical coherence tomography. An increase in retinal thickness is associated with disease progression. A negative value represents a decrease in retinal thickness and therefore a positive clinical outcome measure.'}, {'measure': 'Percent Change in Retinal Fluid From Baseline', 'timeFrame': 'From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study, (visit 10), a maximum of 9 months.', 'description': 'Retinal fluid changes on direct retinal examination on spectral domain - optical coherence tomography. Changes in retinal fluid were compared to baseline values. A negative percentage point represents a decrease in retinal fluid and therefore a positive clinical outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Macula; Degeneration', 'Retina']}, 'descriptionModule': {'briefSummary': 'This protocol is an extension of protocol 0002, Proof of Concept and Dose Ranging Study of carbidopa-levodopa in Neovascular AMD. that is a 3 month study of escalating doses of carbidopa-levodopa in neovascular AMD. This trial is a 9 month extension for patients who successfully complete protocol 0002 and wish to continue carbidopa-levodopa therapy. It will use the two higher dose regimens of protocol 0002. these will be assigned according to how well the higher dose was tolerated in protocol 0002.', 'detailedDescription': 'This extension will employ the same medications, measurements, guidelines for anti-VEGF injections and safeguards as in protocol 0002. In combination with protocol 0002, it will provide a total of 12 months of therapy with carbidopa-levodopa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Completion of Protocol 002.\n2. A diagnosis of AMd with choroidal neovascularization (CNV) in 1 eye.\n3. Normal or Dry AMD of any grade in the second eye.\n4. Age 50-85 years.\n5. Willingness to maintain AREDS vitamin Supplements throughout the study, or remain off of these supplements for the duration of the study, if not taking them prior to the study.\n6. Informed consent at visit 1, which is also Visit 5 of study 002.\n\nExclusion criteria:\n\n1. Any current use of L-DOPA containing medication or dopamine agonist medication, or any planned use of any of these agents, except for study medication, during the study;\n2. Concurrent use of monoamine oxidase (MAO) inhibitors;\n3. Any eye condition, disease, or history of trauma in either eye, which can impair vision, except cataract or cataract surgery;\n4. BCVA worse than 20/60 in the better eye;\n5. Wet AMD in the second eye;\n6. Neurologic conditions which can impair vision;\n7. Parkinson's Disease;\n8. Significant orthostatic hypotension, defined as a drop in systolic blood pressure, immediately upon changing from the supine to standing position, of \\>19 mmHg, or a symptomatic drop in systolic blood pressure, immediately upon changing from the supine to standing position;\n9. Significant ECG abnormalities, as judged by the Investigator;\n10. Estimated glomerular filtration rate (eGFR) \\<20 ml/min;\n11. Liver enzymes \\>3 X the upper limit of normal;\n12. HbA1C \\>9.0;\n13. Any other significant lab abnormalities, as judged by the Investigator.\n14. Women of childbearing potential;\n15. Known retinal hemorrhage;\n16. Subjects who are not fluent in English."}, 'identificationModule': {'nctId': 'NCT03197493', 'briefTitle': 'Extension, Carbidopa-levodopa in Neovascular Age-related Macular Degeneration (AMD)', 'organization': {'class': 'INDIV', 'fullName': 'Snyder, Robert W., M.D., Ph.D., P.C.'}, 'officialTitle': 'Extension of Protocol 002, Carbidopa-levodopa in Neovascular Extension of Protocol 002, Carbidopa-levodopa in Neovascular AMD', 'orgStudyIdInfo': {'id': '0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carbidopa/levodopa high dose', 'description': 'carbidopa-levodopa 25-100 mg 2 tablets TID', 'interventionNames': ['Drug: carbidopa-levodopa 25-100 mg']}], 'interventions': [{'name': 'carbidopa-levodopa 25-100 mg', 'type': 'DRUG', 'otherNames': ['Sinemet'], 'description': 'High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID', 'armGroupLabels': ['Carbidopa/levodopa high dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Robert W Snyder, MD, PhD, PC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Robert W Snyder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Robert W Snyder'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Snyder, Robert W., M.D., Ph.D., P.C.', 'class': 'INDIV'}, 'collaborators': [{'name': 'Snyder Biomedical Corporation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}