Geographic Atrophy Long-Terms Outcomes Study
NCT Number: NCT06499571
Acronym: GALTOS
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Geographic Atrophy
Sponsor: Apellis Pharmaceuticals, Inc.
Collaborators: Iqvia Pty Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 255
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-01
Completion Date: 2023-07-31
Locations: Sydney West Retina, Westmead, New South Wales, NSW 2145, Australia|Centre Hospitalier de la Croix Rousse, Lyon Cedex 04, Rhone, 69004, France|Universitaetsklinikum Muenster, Münster, Nordrhein Westfalen, 48149, Germany|Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco), Milano, 20157, Italy|Belfast Health & SC Trust, Belfast, BT14 6AB, United Kingdom

Summary:
The purpose of this study is to describe functional and long-term clinical outcomes of patients with a diagnosis of Geographic Athrophy secondary to Age related Macular Degenaration in Clinical Practice

Primary Outcome Measures: Change from baseline in GA total area size, Mean GA total area size and Mean change in GA total area size, Through study completion; between 4 and 11 years|Change from baseline in BCVA, Mean BCVA and Mean change in BCVA, Through study completion; between 4 and 11 years|Percentage of participants with visual impairment/blindness, Percentage of participants with moderate/severe visual impairment or blindness, Through study completion; between 4 and 11 years|Percentage of participants with microperimetry assessment, Percentage of participants with any microperimetry assessments since GA diagnosis, Through study completion; between 4 and 11 years|Mean change in functional parameters in patients with microperimetry assessments, Mean/Median and Mean change in retinal sensitivity., Through study completion; between 4 and 11 years|Mean change in functional parameters in patients with microperimetry assessments, Mean/Median and Mean change in fixation stability., Through study completion; between 4 and 11 years|Mean change in functional parameters in patients with microperimetry assessments, Mean/Median and Mean change in number of scotoma points., Through study completion; between 4 and 11 years|Percentage of eyes with disease progression, Percentage of eyes that complete any of the protocol-defined disease progression trajectories and Mean time from GA diagnosis to disease progression, Through study completion; between 4 and 11 years
Secondary Outcome Measures: Proportion of GA eyes with presence of selected characteristics, Proportion of GA eyes with presence of any of the following: nAMD, drusen, pseudodrusen, foveal involvement, unifocal/multifocal GA, hypopigmentation, Through study completion; between 4 and 11 years|Proportion of non-GA eyes with presence of AMD, Proportion of non-GA eyes with presence of any of the following: early/intermediate AMD, nAMD, MNV, Through study completion; between 4 and 11 years|Mortality rate, Mortality rate during study follow-up, From enrollment until end of follow-up; 12 (+6) months after the follow-up period.|GA-related HCRU during the observation period, Number of medical visits (outpatient, low vision clinic, etc.), Through study completion; between 4 and 11 years|GA-related HCRU during the observation period, number of imaging tests (F, A, FAF, CFP, OCT, OCTA, etc.), Through study completion; between 4 and 11 years|GA-related HCRU during the observation period, number of prescribed vision aids, per participant, Through study completion; between 4 and 11 years|Patient-reported HRQoL, Score of the EQ-5D., From enrollment until end of follow-up; 12 (+6) months after the follow-up period.|Patient-reported HRQoL, Score of the HADS, From enrollment until end of follow-up; 12 (+6) months after the follow-up period.|Patient-reported HRQoL, Score of the AQoL-7D for Australian sites only., From enrollment until end of follow-up; 12 (+6) months after the follow-up period.|Patient-reported performance, Scores/answers to the NEI-VFQ-25 questionnaire., From enrollment until end of follow-up; 12 (+6) months after the follow-up period.|Patient-reported performance, Scores/answers to the GALTOS survey., From enrollment until end of follow-up; 12 (+6) months after the follow-up period.|Assisted-care patient journey, Proportion of patients requiring support from an informal caregiver, receiving assisted care at home or in assisted living, From enrollment until end of follow-up; 12 (+6) months after the follow-up period.|Assisted-care patient journey, mean/median time from GA diagnosis to first type of assistance, From enrollment until end of follow-up; 12 (+6) months after the follow-up period.|Financial impact of GA on patients and caregivers, Selected items of the GALTOS survey (including the cost, in the past 12 months, associated to prescriptions, assistive devices, healthcare-related travel, etc.), From enrollment until end of follow-up; 12 (+6) months after the follow-up period.|Associations between patient characteristics and disease progression/functional outcomes and/or clinical/anatomical/functional outcome measures, Measures of association such as correlation coefficients, chi-square statistic, and potentially coefficients from multivariate analysis methods characterizing the relationships of interest, Through study completion; between 4 and 11 years