Ignite Creation Date:
2025-12-24 @ 6:57 PM
Ignite Modification Date:
2026-02-21 @ 11:17 PM
Study NCT ID:
NCT06722157
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D057092', 'term': 'Geographic Atrophy'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000716074', 'term': 'pegcetacoplan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-10-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Slope of change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) in the study eye expressed in millimeter (mm)/year', 'timeFrame': 'At Baseline , at Week 56'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in square root transformed GA area as measured by FAF in the study eye expressed in mm', 'timeFrame': 'At Baseline, at Week 56'}, {'measure': 'Change from baseline in best corrected visual acuity (BCVA) as measured by standardized early trial diabetic retinopathy study (ETDRS) chart in the study eye', 'timeFrame': 'At Baseline, at Week 56'}, {'measure': 'Occurrence of BCVA letter loss of ≥15 letters as measured by standardized ETDRS chart in the study eye for at least 2 consecutive visits', 'timeFrame': 'Up to Week 56'}, {'measure': 'Occurrence of exudative neovascular age-related macular degeneration (eAMD) in the study eye from first drug administration until Week 56', 'timeFrame': 'Up to Week 56'}, {'measure': 'Occurrence of drug-related adverse events (AE) from first drug administration until Week 56', 'timeFrame': 'Up to Week 56'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Macular Degeneration, Age-related', 'Geographic Atrophy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "This study is open to people 50 years or older with an eye condition called geographic atrophy. The purpose of this study is to compare a medicine called BI 771716 with a medicine called pegcetacoplan. BI 771716 is being developed to treat people with geographic atrophy. Pegcetacoplan is a medicine already used to treat people with geographic atrophy.\n\nIn this study, participants receive either BI 771716 or pegcetacoplan as injections in the eye.\n\nParticipants are in the study for a little longer than a year and visit the study site every 4 weeks. At the visits, the study doctor checks the eyes of the participants. The results are compared between the groups of participants to see whether the treatment works. The study doctor also regularly checks participants' health and takes note of any unwanted effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n* Age at least 50 years old at the time of randomization visit\n* Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial\n* Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use are provided in the participant information. Male participants must be ready and able to use either a condom or abstinence as contraceptive measures\n* Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), where the total GA lesion area must be ≥2.5 square millimetres (mm²) and ≤17.5 mm² as measured by Fundus autofluorescence (FAF)\n\n * If multiple lesions are present in the study eye, at least 1 lesion must have an area of ≥1.25 mm²\n * Note: Fellow eye is not required to have GA\n * Note: subfoveal GA lesions (defined as GA lesions within 1 micron of the foveal center point) will be allowed to be enrolled until a maximum is reached of 36 subfoveal lesions in the entire trial (36 is 20% of the total trial population of 180 participants). No more than 36 participants with subfoveal GA lesions should be enrolled. After the maximum of 36 participants is reached, then any participants with subfoveal GA lesions should not be enrolled\n* Fellow eye must have sufficient visual function compared to the study eye, per the investigator's medical judgment in consultation with the patient, to support the patient's daily functioning\n* BCVA letter score of ≥24 letters, using the ETDRS chart in the study eye (equivalent to ≥20/320 on the Snellen chart). Note: If both eyes meet eligibility criteria, the eye with the worse visual function per the investigator's medical judgment in consultation with the patient, will be selected as the study eye. If both eyes have similar visual function, the study eye will be selected per the investigator's medical judgment in consultation with the patient\n* further inclusion criteria apply\n\nExclusion criteria\n\n* GA lesions whose area cannot be accurately defined in the study eye\n* Exudative neovascular AMD (eAMD) in the study eye\n\n \\-- Note: eAMD in the fellow eye is allowed\n* Previously received treatment in the study eye for GA secondary to AMD within 4 months or 5 half-lives prior to baseline, whichever is longer\n* Previously received an investigational medication (oral or intravitreal) for GA secondary to AMD within 4 months or 5 half-lives prior to baseline, whichever is longer\n* Currently enrolled in another investigational device or drug trial, or 30 days or 5 half-lives, whichever is longer since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). Any previous use of gene therapy or cell therapy is not permitted\n* Additional eye disease as follows:\n\n * Any eye disease in the study eye that could compromise BCVA\n * Uncontrolled glaucoma or ocular hypertension with intraocular pressure \\>24 millimetre of mercury (mmHg) in study eye\n * History of high myopia \\>8 diopters in the study eye\n * Anterior segment and vitreous abnormalities that would preclude adequate observation with spectral domain optical coherence tomography in the study eye\n * Ocular conditions at the discretion of the investigator that might interfere with outcome of the trial in the study eye\n * Active intraocular inflammation in the study eye\n * Active infectious conjunctivitis in either eye\n* Prior vitrectomy surgery in the study eye\n* History of major intraocular surgeries including major corneal surgery. Uneventful cataract surgery, refractive surgery, oculoplastic surgery, strabismus surgery, and other extraocular surgery may be permitted if they have occurred more than 3 months prior to baseline in the study eye\n* further exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT06722157', 'acronym': 'VERDANT', 'briefTitle': 'A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Randomized, Double-masked, Active-controlled, Multicenter Study to Evaluate Efficacy and Safety of Two Regimens of Intravitreal BI 771716 Against Pegcetacoplan in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration VERDANT Trial', 'orgStudyIdInfo': {'id': '1497-0002'}, 'secondaryIdInfos': [{'id': 'U1111-1308-7923', 'type': 'REGISTRY', 'domain': 'WHO International Clinical Trials Registry Platform (ICTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: BI 771716', 'interventionNames': ['Drug: BI 771716']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: BI 771716 and Sham comparator', 'interventionNames': ['Drug: BI 771716', 'Drug: Sham comparator to BI 771716']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm C: Pegcetacoplan', 'interventionNames': ['Drug: Pegcetacoplan']}], 'interventions': [{'name': 'BI 771716', 'type': 'DRUG', 'description': 'BI 771716', 'armGroupLabels': ['Arm A: BI 771716', 'Arm B: BI 771716 and Sham comparator']}, {'name': 'Pegcetacoplan', 'type': 'DRUG', 'otherNames': ['Syfovre ®'], 'description': 'Pegcetacoplan', 'armGroupLabels': ['Arm C: Pegcetacoplan']}, {'name': 'Sham comparator to BI 771716', 'type': 'DRUG', 'description': 'Sham comparator to BI 771716', 'armGroupLabels': ['Arm B: BI 771716 and Sham comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85297', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Associated Retina Consultants', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Associated Retina Consultants, Ltd.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Retina Associates', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retina Macula Institute of Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Global Research Management', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Retina Associates of Southern California', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '95356', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Retinal Consultants Medical Group, Inc', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Eye Research Foundation', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92064', 'city': 'Poway', 'state': 'California', 'country': 'United States', 'facility': 'Retina Consultants of San Diego', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Retinal Consultants Medical Group', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Retina Associates - Walnut Creek', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Retina Associates', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Connecticut Eye Consultants, PC', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '06385', 'city': 'Waterford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Retina Group of New England, PC', 'geoPoint': {'lat': 41.3417, 'lon': -72.13597}}, {'zip': '33064', 'city': 'Deerfield Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Rand Eye Institute', 'geoPoint': {'lat': 26.31841, 'lon': -80.09977}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Group of Florida', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33782', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Associates of Pinellas', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '33711', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Vitreous Associates of Florida', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southeast Retina Center, PC', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60439', 'city': 'Lemont', 'state': 'Illinois', 'country': 'United States', 'facility': 'University Retina and Macula Associates', 'geoPoint': {'lat': 41.67364, 'lon': -88.00173}}, {'zip': '60304', 'city': 'Oak Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Retina Associates - Oak Park', 'geoPoint': {'lat': 41.88503, 'lon': -87.7845}}, {'zip': '40206', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Butchertown Clinical Trials', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mid Atlantic Retina Specialists', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Retina Consultants of Minnesota', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '39110', 'city': 'Madison', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Mississippi Retina Associates', 'geoPoint': {'lat': 32.46181, 'lon': -90.11536}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri Health System', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '07003', 'city': 'Bloomfield', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Envision Ocular, LLC', 'geoPoint': {'lat': 40.80677, 'lon': -74.18542}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Eye Associates of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11590', 'city': 'Westbury', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Vitreoretinal Consultants - Westbury', 'geoPoint': {'lat': 40.75566, 'lon': -73.58763}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Verum Research, LLC', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '18017', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mid Atlantic Retina - Bethlehem', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Charleston Neuroscience Institute - Charleston', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Retina', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78750', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Clinical Research, LLC', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77707', 'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas-Beaumont-70319', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas-Bellaire-67493', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Foundation of the Southwest', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77494', 'city': 'Katy', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas - Katy', 'geoPoint': {'lat': 29.78579, 'lon': -95.8244}}, {'zip': '75024', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Red River Research Partners, LLC', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Retinal Consultants of San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78154', 'city': 'Schertz', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas - Schertz', 'geoPoint': {'lat': 29.55217, 'lon': -98.26973}}, {'zip': '77384', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas-The Woodlands-67575', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Retina Associates of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '24502', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Piedmont Eye Center', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Spokane Eye Clinic', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}]}, 'ipdSharingStatementModule': {'url': 'https://www.mystudywindow.com/msw/datasharing', 'timeFrame': 'One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.', 'ipdSharing': 'YES', 'description': 'Once the criteria in section \'time frame\' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.', 'accessCriteria': "For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}