Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT05155293
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2021-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 413}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-26', 'studyFirstSubmitDate': '2021-12-01', 'studyFirstSubmitQcDate': '2021-12-01', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA)', 'timeFrame': 'Week 8'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Macular Degeneration', 'Retinal Degeneration', 'Aflibercept'], 'conditions': ['Neovascular (Wet) AMD']}, 'referencesModule': {'references': [{'pmid': '40512025', 'type': 'DERIVED', 'citation': 'Agostini H, Baumane K, Balciuniene VJ, Ozols K, Soni R, Hamdi S, Cirillo S, Rai M, Otto H, Leutz S, Sattar A, Berti F. A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opin Biol Ther. 2025 Jul;25(7):773-787. doi: 10.1080/14712598.2025.2519531. Epub 2025 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in subjects with neovascular (wet) AMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be ≥50 years of age, at the time of signing the informed consent.\n* Subjects must be diagnosed with neovascular (wet) AMD in the study eye.\n* Subjects must have active, treatment naïve, subfoveal CNV lesions secondary to neovascular (wet) AMD.\n* Willingness and ability to undertake all scheduled visits and assessments.\n\nExclusion Criteria:\n\n* Any prior systemic treatment with anti-VEGF therapy\n* Any condition that, in the Investigator ́s opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data\n* Prior treatment with any investigational drugs within 30 days or 5 half-lives (whichever is longer) of the previous investigational treatment before initiation of the study treatment or concomitant enrollment in any other clinical study involving an investigational study treatment\n* Subjects not suitable for participation, whatever the reason, as judged by the Investigator, including medical or psychiatric conditions, or participants potentially at risk of noncompliance to study procedures.'}, 'identificationModule': {'nctId': 'NCT05155293', 'acronym': 'ALVOEYE', 'briefTitle': 'Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alvotech Swiss AG'}, 'officialTitle': 'A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT06 Compared With EU-Eylea® in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALVOEYE)', 'orgStudyIdInfo': {'id': 'AVT06-GL-C01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AVT06 (proposed aflibercept biosimilar)', 'description': 'Patients will receive 1 IVT injection of AVT06 every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.', 'interventionNames': ['Drug: AVT06 (proposed aflibercept biosimilar)']}, {'type': 'EXPERIMENTAL', 'label': 'Eylea® (Aflibercept)', 'description': 'Patients will receive 1 IVT injection of Eylea® every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.', 'interventionNames': ['Drug: Eylea® (Aflibercept)']}], 'interventions': [{'name': 'AVT06 (proposed aflibercept biosimilar)', 'type': 'DRUG', 'description': 'Patients will receive IVT injections of AVT06', 'armGroupLabels': ['AVT06 (proposed aflibercept biosimilar)']}, {'name': 'Eylea® (Aflibercept)', 'type': 'DRUG', 'description': 'Patients will receive IVT injections of Eylea®', 'armGroupLabels': ['Eylea® (Aflibercept)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35601', 'city': 'Sokolov', 'country': 'Czechia', 'facility': 'Nemocnicni lekarna Sokolov', 'geoPoint': {'lat': 50.1813, 'lon': 12.6401}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'JSC Evex Medical Corporation', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '812 0011', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Keneikai Hayashi Eye Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '10006', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Riga East University Hospital Clinical Centre "Bikernieki"', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': '1002', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Pauls Stradins Clinical University Hospital SLLC', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': '911 71', 'city': 'Trenčín', 'country': 'Slovakia', 'facility': 'Fakultna Nemocnica Trencin', 'geoPoint': {'lat': 48.89452, 'lon': 18.04436}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alvotech Swiss AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}