Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT04690556
Status:
COMPLETED
Last Update Posted:
2024-08-07
First Post:
2020-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Compare Efficacy and Safety of LUBT010 and Lucentis® in Patients With Neovascular AMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-15'}], 'estimatedResultsFirstSubmitDate': '2025-12-15'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, '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': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2020-12-29', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in BCVA from baseline in the study eye at the end of 12, months assessed with the ETDRS chart', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Mean change in BCVA from baseline in the study eye accessed with the ETDRS chart', 'timeFrame': '3 months, 6 months and 9 months'}, {'measure': 'Proportion of patients with anti-drug antibodies', 'timeFrame': '1, 3, 6, 9, and 12 months'}, {'measure': 'Adverse Events (AEs)', 'timeFrame': 'Baseline to 12 months', 'description': 'Number of patients with treatment-emergent adverse events'}, {'measure': 'Ophthalmic examination', 'timeFrame': 'Baseline to 12 months', 'description': 'Number of patients with clinically significant ophthalmic examination findings'}, {'measure': 'Physical & systemic examination', 'timeFrame': 'Baseline to 12 months', 'description': 'Number of patients with clinically significant physical \\& systemic examination findings.'}, {'measure': 'Vital Signs', 'timeFrame': 'Baseline to 12 months', 'description': 'Number of patients with clinically significant vital signs findings'}, {'measure': 'ECGs', 'timeFrame': 'Baseline to 12 months', 'description': 'Number of patients with clinically significant ECG findings'}, {'measure': 'Clinical Laboratory Tests', 'timeFrame': 'Baseline to 12 months', 'description': 'Number of patients with clinically significant laboratory test findings'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neovascular age-related macular degeneration, Ranibizumab'], 'conditions': ['Neovascular Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This study is designed to compare the efficacy, safety and immunogenicity of LUBT010 with Lucentis® given as once monthly intravitreal injection in patients with neovascular age-related macular degeneration (AMD).', 'detailedDescription': 'This is a global, phase III, double blind, randomized controlled study to compare the efficacy, safety \\& immunogenicity of LUBT010 with Lucentis® in patients with neovascular age-related macular degeneration.\n\nEligible patients will be randomly assigned in 1:1 ratio to receive once monthly intravitreal injection of LUBT010 or Lucentis® for 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ambulatory male or female participants with age ≥ 50 years at the time of screening\n2. Capable of understanding and giving written informed consent\n3. Primary or recurrent (anti-VEGF naïve) active CNV lesions involving the foveal center secondary to AMD\n4. BCVA between 20/40 and 20/200 (Snellen equivalent) in the study eye, using ETDRS testing\n5. Willingness and ability to undertake all scheduled visits and assessments\n\nExclusion Criteria:\n\n1. Known hypersensitivity to ranibizumab or any of the components of study medication\n2. Known history of allergy to fluorescein dye\n3. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye\n4. Subretinal hemorrhage in the study eye that involves the center of the fovea\n5. Uncontrolled glaucoma\n6. Use of prohibited treatments\n\nOther In-/Exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT04690556', 'briefTitle': 'Study to Compare Efficacy and Safety of LUBT010 and Lucentis® in Patients With Neovascular AMD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lupin Ltd.'}, 'officialTitle': 'A Global, Phase III, Double Blind, Randomized Controlled Study to Compare the Efficacy, Safety & Immunogenicity of LUBT010 With Lucentis® in Patients With Neovascular Age Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'LRP/LUBT010/2016/008'}, 'secondaryIdInfos': [{'id': '2017-004409-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lucentis (ranibizumab)', 'description': 'Intravitreal injection', 'interventionNames': ['Drug: Lucentis (ranibizumab)']}, {'type': 'EXPERIMENTAL', 'label': 'LUBT010 (proposed ranibizumab biosimilar)', 'description': 'Intravitreal injection', 'interventionNames': ['Drug: LUBT010 (proposed ranibizumab biosimilar)']}], 'interventions': [{'name': 'Lucentis (ranibizumab)', 'type': 'DRUG', 'description': 'Lucentis® 0.5 mg via intravitreal injection once monthly', 'armGroupLabels': ['Lucentis (ranibizumab)']}, {'name': 'LUBT010 (proposed ranibizumab biosimilar)', 'type': 'DRUG', 'description': 'LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly', 'armGroupLabels': ['LUBT010 (proposed ranibizumab biosimilar)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '781003', 'city': 'Guwahati', 'state': 'Assam', 'country': 'India', 'facility': 'The Eye Care Center', 'geoPoint': {'lat': 26.1844, 'lon': 91.7458}}, {'zip': '380015', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Rising Retina Clinic', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380016', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Government Eye Hospital M & J Institute of Ophthalmology', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '382428', 'city': 'Gandhinagar', 'state': 'Gujarat', 'country': 'India', 'facility': 'Kanoria Hospital and Research Center', 'geoPoint': {'lat': 23.21667, 'lon': 72.68333}}, {'zip': '395001', 'city': 'Surat', 'state': 'Gujarat', 'country': 'India', 'facility': 'Shivam Retina Clinic and Eye Hospital', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '395004', 'city': 'Surat', 'state': 'Gujarat', 'country': 'India', 'facility': 'Kiran Hospital Multi Super Speciality Hospital & Research Centre', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '834001', 'city': 'Ranchi', 'state': 'Jharkhand', 'country': 'India', 'facility': 'Kashyap Memorial Eye Hospital Pvt. Ltd.', 'geoPoint': {'lat': 23.34316, 'lon': 85.3094}}, {'zip': '560094', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Nethra Eye Hospital', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '570001', 'city': 'Mysore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Mysore Medical College and Research Institute', 'geoPoint': {'lat': 12.29791, 'lon': 76.63925}}, {'zip': '570004', 'city': 'Mysore', 'state': 'Karnataka', 'country': 'India', 'facility': 'JSS Hospital', 'geoPoint': {'lat': 12.29791, 'lon': 76.63925}}, {'zip': '431010', 'city': 'Aurangabad', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Kamalnayan Bajaj Hospital', 'geoPoint': {'lat': 19.87757, 'lon': 75.34226}}, {'zip': '400031', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Aditya Jyot Eye Hospital Pvt. Ltd.', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400050', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Shroff Eye Hospital & Vision Research Centre', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400056', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Anideep Eye Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400056', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Topiwala National Medical College & B. Y. L. Nair Charitable Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '422002', 'city': 'Nashik', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Dhadiwal Hospital in Coalition with Shreeji Healthcare', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'zip': '401303', 'city': 'Pālghar', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Vijay Vallabh Hospital and Medical Research Center', 'geoPoint': {'lat': 19.69693, 'lon': 72.76543}}, {'zip': '411039', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Insight Institute of Ophthalmology', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '160012', 'city': 'Chandigarh', 'state': 'Punjab', 'country': 'India', 'facility': 'Advanced Eye Centre Post Graduate Institute of Medical Education & Research'}, {'zip': '208005', 'city': 'Kanpur', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Dr. J L Rohatgi Memorial Eye Hospital', 'geoPoint': {'lat': 26.46523, 'lon': 80.34975}}, {'zip': '226003', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': "King George's Medical University", 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '221010', 'city': 'Varanasi', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'R.K.Netralaya Eye Hospital (P) Ltd.', 'geoPoint': {'lat': 25.31668, 'lon': 83.01041}}, {'zip': '700073', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Regional Institute of Ophthalmology', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '110002', 'city': 'New Delhi', 'country': 'India', 'facility': "Dr. Shroff's Charity Eye Hospital", 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '110060', 'city': 'New Delhi', 'country': 'India', 'facility': 'Sir Ganga Ram Hosptial', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '110075', 'city': 'New Delhi', 'country': 'India', 'facility': 'Aakash Healthcare Super Specialty Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lupin Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}