Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-28 @ 11:01 PM
Study NCT ID:
NCT01535950
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2012-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057135', 'term': 'Wet Macular Degeneration'}, {'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'dispFirstSubmitDate': '2016-03-22', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2012-02-10', 'dispFirstSubmitQcDate': '2016-03-22', 'studyFirstSubmitQcDate': '2012-02-15', 'dispFirstPostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time', 'timeFrame': 'Day 1 to 113', 'description': 'Number or retreatments with anti-VEGF treatments will be recorded'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients in the study that requires at least one treatment of anti-VEGF medication.', 'timeFrame': 'Day 1 and 113', 'description': 'Number or retreatments with anti-VEGF treatments will be recorded'}, {'measure': 'Effect of LFG316 on visual acuity', 'timeFrame': 'Day 1 and 113', 'description': 'Early Treatment Diabetic Retinopathy Study" (ETDRS best corrected visual acuity measured under ESTDRS conditions Number of letters correctly read will be recorded.'}, {'measure': 'Effect of LFG316 on central retinal thickness and choroidal neovascular membrane area, and drusen area/volume where applicable', 'timeFrame': 'Day 1 , Day 85 and Day 113 (starting from the day of first IVT injection until end of study)', 'description': 'Summary statistics of these variables will be provided by treatment and visit/time. Treatment effect will be assessed by comparison of mean change from baseline to Day 85.'}, {'measure': 'Serum concentrations of total LFG316 versus time', 'timeFrame': 'Days 1, 8, 15, 29, 43, 57, 71, 85 and 113', 'description': 'Blood samples will be collected'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'Day 113', 'description': 'Adverse events will be determined based on descriptive analyses of vital signs, electrocardiogram (ECG) evaluation, and clinical safety laboratory evaluations. All abnormalities will be flagged and summary statistics will be provided by treatment and visit/time.'}]}, 'conditionsModule': {'keywords': ['Age-related macular degeneration', 'intravitreal, neovascular', 'anti-vascular endothelial growth factor', 'wet AMD', 'Age-related', 'Macular degeneration', 'Intravitreal', 'Neovascular'], 'conditions': ['Neovascular Age-elated Macular Degeneration (Wet AMD)', 'Exudative Macular Degeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=12244', 'label': 'Results for CLFG316A2202 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and efficacy of LFG316 in patients with age related macular degeneration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Best corrected visual acuity (ETDRS scale) of 60 letters or less in the study eye.\n* An active choroidal neovascular membrane attributable to neovascular AMD in at least one eye.\n* History of treatment (at any time) with at least 3 doses of anti-VEGF therapy in the study eye.\n\nExclusion Criteria:\n\n* History of recurrent non-response to anti-VEGF therapy in the study eye.\n* In the study eye, retinal disease other than AMD (benign conditions of the vitreous and peripheral retina are not exclusionary).\n* Choroidal neovascularization due to a cause other than AMD.\n* In the study eye, media opacity that, in the investigator's opinion, could interfere with conduct of the study.\n* History of infectious uveitis or endophthalmitis in either eye.\n* Any of the following treatments to the study eye within 28 days prior to dosing: ranibizumab, bevacizumab, pegaptanib or other VEGF inhibitor.\n* Any of the following within 90 days prior to dosing: photodynamic therapy or laser photocoagulation in the study eye; intravitreal steroid in the study eye; or intraocular surgery (including cataract surgery) in the study eye"}, 'identificationModule': {'nctId': 'NCT01535950', 'briefTitle': 'Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Randomized, Sham-controlled, Repeat-dose Study to Assess the Safety, Tolerability, Serum Pharmacokinetics, and Efficacy of Intravitreal LFG316 in Patients With Neovascular Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': 'CLFG316A2202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LFG316', 'interventionNames': ['Drug: LFG316']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LFG316', 'type': 'DRUG', 'armGroupLabels': ['LFG316']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle.', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85704-5614', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90503', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33912-7125', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '21237-4350', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '29169', 'city': 'West Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.99349, 'lon': -81.07398}}, {'zip': '79606', 'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}