Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-27 @ 5:11 AM
Study NCT ID:
NCT07064759
Status:
RECRUITING
Last Update Posted:
2025-10-20
First Post:
2025-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D057135', 'term': 'Wet Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, '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': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2025-07-07', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from baseline in Best Corrected Visual Accuity (BCVA) Early Treatment for Diabetic Retinopathy (ETDRS) letter score at Week 52', 'timeFrame': '52 Weeks'}], 'secondaryOutcomes': [{'measure': 'Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104', 'timeFrame': '104 Weeks'}, {'measure': 'Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104', 'timeFrame': '104 Weeks'}, {'measure': 'Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm', 'timeFrame': '104 Weeks'}, {'measure': 'Mean change from baseline in Central Subfield Thickness (CST) over time through Weeks 52 and 104', 'timeFrame': '104 Weeks'}, {'measure': 'Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104', 'timeFrame': '104 Weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Age-related macular degeneration', 'AMD', 'Exudative AMD', 'Neovascular AMD', 'Exudative age-related macular degeneration', 'Neovascular age-related macular degeneration', 'Wet age-related macular degeneration', 'Wet macular degeneration', 'Wet AMD', 'WAMD', 'nAMD', 'Retinal gene therapy', 'Intravitreal gene therapy', 'Genetic Medicine', 'Ocular Gene Therapy', 'Gene Therapy', '4FRONT', '4FRONT-2'], 'conditions': ['Neovascular Age-Related Macular Degeneration (nAMD)']}, 'descriptionModule': {'briefSummary': 'A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥50 years of age at time of consent\n* MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER:\n\n 1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR\n 2. Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator\n* Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT) , in the study eye, at the Screening Visit confirmed by the Reading Center\n* Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center\n* BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit\n* CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center\n\nExclusion Criteria:\n\nOcular Conditions:\n\n* MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter)\n* History of retinal detachment in the study eye\n* History of or presence of active inflammation in either eye\n* Glaucoma or intraocular hypertension requiring more than 2 topical medications for control\n\nOcular Treatments/Interventions:\n\n* Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye\n\nSystemic Conditions and Considerations:\n\n* Major illness or major surgical procedure in the 28 days prior to the Screening Visit\n* Uncontrolled blood pressure\n* Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit\n* History of autoimmune condition that may predispose to the development of uveitis'}, 'identificationModule': {'nctId': 'NCT07064759', 'acronym': '4FRONT-2', 'briefTitle': 'Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': '4D Molecular Therapeutics'}, 'officialTitle': 'A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults With Macular Neovascularization Secondary to Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': '4D-150-C004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4D-150 IVT (3E10 vg/eye)', 'interventionNames': ['Biological: 4D-150 IVT (3E10 vg/eye)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aflibercept (AFLB) 2 mg IVT', 'interventionNames': ['Biological: EYLEA® (aflibercept) Injection 2 mg (0.05mL)']}], 'interventions': [{'name': '4D-150 IVT (3E10 vg/eye)', 'type': 'BIOLOGICAL', 'description': 'If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1', 'armGroupLabels': ['4D-150 IVT (3E10 vg/eye)']}, {'name': 'EYLEA® (aflibercept) Injection 2 mg (0.05mL)', 'type': 'BIOLOGICAL', 'description': 'Eylea (aflibercept) will be administered at applicable visits', 'armGroupLabels': ['Aflibercept (AFLB) 2 mg IVT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Blossom Bakhda', 'role': 'CONTACT', 'email': 'blossom.bakhda@researchavp.com'}, {'name': 'Suhail Alam, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Barnet Dulaney Perkins Eye Center', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Merz', 'role': 'CONTACT', 'email': 'amerz@retinatucson.com'}, {'name': 'Cameron Javid, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Retina Associates', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '95008', 'city': 'Campbell', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Meghan V', 'role': 'CONTACT', 'email': 'meghanv@retinaldiagnostic.com'}, {'name': 'Amr Dessouki, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Retinal Diagnostic Center', 'geoPoint': {'lat': 37.28717, 'lon': -121.94996}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steve Tyson', 'role': 'CONTACT', 'email': 'stevetheeyeguy@aol.com'}, {'name': 'Ashkan Pirouz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Retina Consultants of Orange County', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nina Ansari', 'role': 'CONTACT', 'email': 'nansari@westcoastretina.com'}, {'name': 'Michael Jumper, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West Coast Retina Medical Group', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '81303', 'city': 'Durango', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aaron Redner', 'role': 'CONTACT', 'email': 'aredner@sweyeconsultants.com'}, {'name': 'Sara Haug, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southwest Retina Consultants', 'geoPoint': {'lat': 37.27528, 'lon': -107.88007}}, {'zip': '34667', 'city': 'Hudson', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'America Deupree', 'role': 'CONTACT', 'email': 'america@retinatb.com'}, {'name': 'Dana Deupree, MD, FASRS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ClearVista Clinical Research', 'geoPoint': {'lat': 28.36445, 'lon': -82.69343}}, {'zip': '33617', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ledar Bataku', 'role': 'CONTACT', 'email': 'lbataku@rvaf.com'}, {'name': 'Ashley Crane, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Retina Vitreous Associates of Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30328', 'city': 'Sandy Springs', 'state': 'Georgia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathy Wynne', 'role': 'CONTACT', 'email': 'kathyw@thomaseye.com'}, {'name': 'Paul Kaufman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Thomas Eye Group', 'geoPoint': {'lat': 33.92427, 'lon': -84.37854}}, {'zip': '21209', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amanda McGee', 'role': 'CONTACT', 'email': 'amcgee@retinacarecenter.com'}, {'name': 'Eric Suan, MD, FACS, FASRS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Retina Care Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emma Melvin', 'role': 'CONTACT', 'email': 'emelvin@retinacare.net'}, {'name': 'Allen Hu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cumberland Valley Retina Consultants', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maribel Rodriguez', 'role': 'CONTACT', 'phone': 'mr3208@cumc.columbia.edu'}, {'name': 'Tongalp Tezel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New York Presbyterian Hospital - Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11590', 'city': 'Westbury', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ewelina Lokaj', 'role': 'CONTACT', 'email': 'elokaj@vrcny.com'}, {'name': 'James Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vitreoretinal Consultants of NY', 'geoPoint': {'lat': 40.75566, 'lon': -73.58763}}, {'zip': '27511', 'city': 'Cary', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Chow', 'role': 'CONTACT', 'email': 'cchow@ncretina.com'}, {'name': 'Laura Snyder, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'North Carolina Retina Associates', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelye Conrad', 'role': 'CONTACT', 'email': 'kconrad@cvphealth.com'}, {'name': 'Robert Sisk, MD, FACS, FASRS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '947401', 'city': 'Eugene', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lillian Carroll', 'role': 'CONTACT', 'email': 'lcarroll@verumresearch.com'}, {'name': 'Albert Edwards, MD, PhD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Verum Research, LLC', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '29910', 'city': 'Bluffton', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julia Topping', 'role': 'CONTACT', 'email': 'j.topping@retinasouthcarolina.com'}, {'name': 'Mona Camacci, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charleston Neuroscience Institute, LLC', 'geoPoint': {'lat': 32.23715, 'lon': -80.86039}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Daniel', 'role': 'CONTACT', 'email': 'mary.daniel@cepmd.com'}, {'name': 'Jonathan Brugger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carolina Eyecare', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Armijo', 'role': 'CONTACT', 'email': 'marmijo@tnretina.com'}, {'name': 'Carl Awh, MD, FASRS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tennessee Retina, PC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kasey Dalrymple', 'role': 'CONTACT', 'email': 'kasey.dalrymple@paneye.com'}, {'name': 'Jason Edward Ysasaga, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southwest Retina Specialist - Panhandle Eye group, LLP', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Hughes', 'role': 'CONTACT', 'email': 'ahughes@texasretina.com'}, {'name': 'Ashkan Abbey, MD, FASRS, FAAO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Retina Associate', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75703', 'city': 'Tyler', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Long', 'role': 'CONTACT', 'email': 'mlong@tylerretina.com'}, {'name': 'Samuel Minaker, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tyler Retina Consultants', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hollie Murphy', 'role': 'CONTACT', 'email': 'hmurphy@rockymountainretina.com'}, {'name': 'Mitchell Goff, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rocky Mountain Retina Consultants', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98383', 'city': 'Silverdale', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anna Nelson', 'role': 'CONTACT', 'email': 'a.nelson@pnwretina.com'}, {'name': 'Todd Schneiderman, MD, FASRS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pacific Northwest Retina', 'geoPoint': {'lat': 47.64454, 'lon': -122.69487}}], 'centralContacts': [{'name': '4DMT Patient Advocacy', 'role': 'CONTACT', 'email': 'clinicaltrials@4DMT.com', 'phone': '(888) 748-8881'}], 'overallOfficials': [{'name': 'Julie Tsai, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': '4D Molecular Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data obtained through this study may be provided, after deidentification, to qualified researchers with academic interest in AMD in compliance with ICMJE policy. Data or samples shared will be coded, with no Protected Health Information included. Additionally, descriptions of the study protocol, Statistical Analysis Plan (SAP), informed consent and clinical study report may be shared publicly. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting after final Clinical Study Report and the data will be made accessible for a duration determined by the Sponsor, and in accordance with ICMJE policy. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and SAP and execution of a Data Sharing Agreement (DSA).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '4D Molecular Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}