Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-30 @ 11:57 PM
Study NCT ID:
NCT05345769
Status:
COMPLETED
Last Update Posted:
2024-12-12
First Post:
2022-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of AM712 in Patients with NAMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The Phase 1 study is comprised of open-label multiple ascending-dose component (Part 1) and high concentration component (Part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients with neovascular age- related macular degeneration (nAMD).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-07', 'studyFirstSubmitDate': '2022-04-12', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of ocular adverse events (AEs) of the study eyes', 'timeFrame': '252 days', 'description': 'To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)'}, {'measure': 'Incidence of non-ocular AEs', 'timeFrame': '252 days', 'description': 'To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)'}, {'measure': 'Any relevant safety observations derived from BCVA', 'timeFrame': '252 days', 'description': 'To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)'}, {'measure': 'Any relevant safety observations derived from SD-OCT', 'timeFrame': '252 days', 'description': 'To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)'}], 'secondaryOutcomes': [{'measure': 'Mean change from baseline in central subfield thickness as assessed by SD-OCT', 'timeFrame': '252 days', 'description': 'To evaluate the efficacy of AM712 in Subjects with nAMD'}, {'measure': 'Proportion of patients with no intraretinal fluid, subretinal fluid, or pigment epithelial detachment as assessed by SD-OCT', 'timeFrame': '252 days', 'description': 'To evaluate the efficacy of AM712 in Subjects with nAMD'}, {'measure': 'Mean change from baseline in BCVA (ETDRS)', 'timeFrame': '252 days', 'description': 'To evaluate the efficacy of AM712 in Subjects with nAMD'}, {'measure': 'Proportion of patients gaining ≥ 15 letters from baseline BCVA', 'timeFrame': '252 days', 'description': 'To evaluate the efficacy of AM712 in Subjects with nAMD'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nAMD'], 'conditions': ['Neovascular Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase 1 study is comprised of multiple ascending-dose component (Part 1) and high concentration component (Part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients with neovascular age- related macular degeneration (nAMD).', 'detailedDescription': 'The Part 1 of study is a multicenter, open-label, sequentially, multiple ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with nAMD.\n\nSubjects will be sequentially enrolled into different dose-level cohorts following the traditional "3+3" design until the maximally tolerated dose (MTD) or the maximally administered dose (MAD) has been reached.\n\nThe Part 2 of study is a multicenter, open-label, sequential study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in treatment-naïve patients with nAMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects with 50 years of age or older\n2. Active sub-foveal CNV lesion secondary to nAMD including juxta or extra-foveal lesions that partially affect the fovea\n3. The area of CNV must occupy at least 50% of total lesion\n4. Total lesion area ≤ 12 DA\n5. ETDRS BCVA letter score measured at screening and baseline\n6. Clear ocular media and adequate pupil dilation to permit good quality photographic imaging in study eye\n\nExclusion Criteria:\n\n1. Any previous systemic anti-VEGF treatment\n2. Any systemic treatment or therapy to treat neovascular AMD\n3. Continuous use of systemic corticosteroids\n4. Diseases that affect intravenous injection and venous blood sampling\n5. Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia in study eye\n6. History or any concurrent ocular condition which, in opinion of investigator, could either confound interpretation of efficacy and safety of IP or require medical or surgical intervention.\n7. The area of fibrosis occupies ≥ 50% of total lesion area in study eye\n8. Evidence of myopia degeneration, diagnosis supported by the axial length examination in study eye\n9. History or any concurrent macular abnormality other than AMD in study eye\n10. Current vitreous hemorrhage or history of vitreous hemorrhage in study eye\n11. History of recurrent inflammation in study eye\n12. History of treatment for nAMD\n13. Subject having out of range laboratory values defined as:\n\nALT or AST \\> 2 x ULN, total bilirubin \\> 1.5 x ULN Serum creatinine \\> 1.5 x ULN, BUN \\> 2 x ULN HbA1c \\> 7.5% at screening'}, 'identificationModule': {'nctId': 'NCT05345769', 'briefTitle': 'Safety and Efficacy of AM712 in Patients with NAMD', 'organization': {'class': 'INDUSTRY', 'fullName': 'AffaMed Therapeutics Limited'}, 'officialTitle': 'A Prospective, Multi-Center, Open-label, Sequential, Multiple Ascending-Dose and High Concentration Cohorts Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AM712 Following Intravitreal Administration in Patients with Neovascular Age-related Macular Degeneration.', 'orgStudyIdInfo': {'id': 'AM712E1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase I- All', 'description': 'Subjects with neovascular AMD', 'interventionNames': ['Biological: AM712(ASKG712)']}], 'interventions': [{'name': 'AM712(ASKG712)', 'type': 'BIOLOGICAL', 'description': 'AM712 is a recombinant anti-VEGF humanized monoclonal antibody and Ang-2 antagonist peptide fusion protein, which has high specificity for the binding of VEGF-A and Ang-2.', 'armGroupLabels': ['Phase I- All']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92064', 'city': 'Poway', 'state': 'California', 'country': 'United States', 'facility': 'Retina Consultants San Diego', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Retina Associates', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Retina', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '32901', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Eye Associates', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Retina Research Institute at New England Retina Consultants', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Retina, PC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77384', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AffaMed Therapeutics Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}