Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-04 @ 4:41 PM
Study NCT ID:
NCT06351657
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2024-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2024-04-02', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for fast geographic atrophy (GA) progression', 'timeFrame': '2 years', 'description': 'The association between biomarkers and GA progression will be assessed by linear mixed models. Artificial intelligence models will be applied to assess progression speed and predict local and global progression.\n\nMixed Effects models will be calculated to estimate the association between the above mentioned independent variables, including the timepoint as an independent variable, on individual markers of progression (RPE and PR thinning).\n\nThe r-squared value of the predicted increase in atrophy area will be used as an endpoint assessment to evaluate the predictive model.'}], 'secondaryOutcomes': [{'measure': 'To identify and quantify disease progression-related biomarkers', 'timeFrame': '2 years', 'description': 'Longitudinal assessments of imaging biomarkers are performed in a descriptive manner. The following biomarkers will be evaluated in detail as independent variables:\n\n* Hyperreflective Foci (HRF) (scale, nL)\n* Drusen volume/Refractile drusen (scale, nL)\n* Subretinal Drusenoid Deposits (SDD) (scale, mm2)\n* PR loss/RPE loss ratio (scale, ratio)\n* GA lesion size (mm2)\n* Foveal involvement (categorical; yes or no)\n* Thinning of outer retinal layers (PR thinning) (scale, µm)\n* Other retinal biomarkers if relevant to the progression of GA\n\nThe association between biomarkers and GA progression will be assessed by linear mixed models.'}, {'measure': 'To evaluate monitoring AMD progression using approved AI algorithms.', 'timeFrame': '2 years', 'description': 'The following will be provided by AI-based image analysis of the GA Monitor (independent variables):\n\n* RPE integrity loss (mm2) in the 1mm central area, 6mm area, and the respective relative change to previous visit\n* PR integrity loss (mm2) in the 1mm central area, 6mm area, and the respective relative change to previous visit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration', 'Geographic Atrophy']}, 'descriptionModule': {'briefSummary': "The goal of this prospective, multinational, multicenter observational study is to assess and predict progression in non-foveal, non-vision compromising atrophic AMD on an individual-based level over two years. The main objectives of this study are:\n\n* Assess the individual progression rate of a patient in non-foveal, non-vision compromising atrophic AMD and assess personalized risk of progression based on imaging.\n* Identify and quantify focal and global alterations in the retina in regard to disease progression.\n* Evaluate the monitoring of AMD progression using approved AI algorithms.\n\nAll patients will be followed for 24 months with 6 month intervals to assess clinical changes. Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures:\n\n* Scanning Laser Fundus Photography\n* Color Fundus Photography (CFP)\n* Optical Coherence Tomography (OCT)\n* Optical Coherence Tomography Angiography (OCTA)\n\nPatients will be asked for their medical history. Standard ophthalmic examination, as well as a questionnaire on visual function will be carried out.\n\nNo intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients will be recruited from each center's respective outpatient clinic and/or by referral from primary eye care (e.g. optometrist).", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 55-99 years old\n* Complete RPE and outer retinal atrophy (cRORA). This is (1) a region of hypertransmission of at least 250 µm in diameter, (2) a zone of attenuation or disruption of the RPE of at least 250 µm in diameter, (3) evidence of overlying photoreceptor degeneration, and (4) absence of scrolled RPE or other signs of an RPE tear.\n* If both eyes are eligible, both eyes will be included in the cohort study.\n* Clear optical media and adequate pupillary dilation for imaging and functional testin\n\nExclusion Criteria:\n\n* Any surgical treatment of the eye within 3 months prior to baseline in the study eye\n* History of anti-VEGF treatment in the study eye before baseline\n* History of pseudophakic cystoid macular edema (Irvine Gass Syndrome) in the study eye\n* History of uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg despite treatment with IOP lowering medication), or C/D Ratio \\> 0.9\n* Any concurrent intraocular condition in the study eye (e.g. advanced cataract or moderate/severe diabetic retinopathy) that, in the opinion of the investigator, will most likely require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition\n* Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could cause an unwanted effect on treatment efficacy, compliance or require intraocular surgery (except for cataract surgery and YAG capsulotomy) during the study period\n* Presence of corneal decompensation, haze or scarring with an impact on BCVA\n* Refractive error larger than 6 diopters. In case of pseudophakia or refractive surgery: History of refractive error larger than 6 diopters.\n* Intake of drugs known to cause retinal toxicity (e.g. hydroxychloroquine or tamoxifen)\n* Presence of active macular neovascularization at baseline.'}, 'identificationModule': {'nctId': 'NCT06351657', 'acronym': 'APENNINES', 'briefTitle': 'Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression in a Prospective, Multinational, Multicenter Observational Study', 'orgStudyIdInfo': {'id': '1088/2024'}}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Gregor S Reiter, Priv.-Doz. Ing. DDr., BA MSc', 'role': 'CONTACT', 'email': 'gregor.reiter@meduniwien.ac.at', 'phone': '+4314040073419'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine Creuzot-Garcher, MD', 'role': 'CONTACT', 'email': 'catherine.creuzot-garcher@chu-dijon.fr', 'phone': '+33380293756'}], 'facility': 'CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Polona Jaki-Mekjavic, MD', 'role': 'CONTACT', 'email': 'polona.jakimekjavic@kclj.si', 'phone': '+38615221900'}], 'facility': 'University Medical Center Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier Zarranz-Ventura', 'role': 'CONTACT', 'email': 'zarranz@clinic.cat', 'phone': '+34617926250'}], 'facility': 'Fundacio de Recerca Clinic Barcelona-Institut D Investigacions Biomed', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Binningen', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Katja Hatz', 'role': 'CONTACT', 'email': 'Katja.Hatz@vista.ch', 'phone': '+41614266079'}], 'facility': 'Vista Klinik Binningen', 'geoPoint': {'lat': 47.54021, 'lon': 7.56932}}, {'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Daniel Barthelmes', 'role': 'CONTACT', 'email': 'Daniel.Barthelmes@usz.ch', 'phone': '+41432530598'}], 'facility': 'University of Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Belfast', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ruth Hogg', 'role': 'CONTACT', 'email': 'r.e.hogg@qub.ac.uk', 'phone': '+447734671087'}], 'facility': "Queen's Unviversity Belfast", 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'centralContacts': [{'name': 'Gregor Reiter, Priv.-Doz. Ing. DDr., BA MSc', 'role': 'CONTACT', 'email': 'gregor.reiter@meduniwien.ac.at', 'phone': '+43 1 40400-73419'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, {'name': 'University of Zurich', 'class': 'OTHER'}, {'name': 'Vista Klinik', 'class': 'OTHER'}, {'name': "Queen's University, Belfast", 'class': 'OTHER'}, {'name': 'Fundacion Clinic per a la Recerca Biomédica', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gregor Reiter', 'investigatorAffiliation': 'Medical University of Vienna'}}}}