Geographic Atrophy
Conditions
Keywords
GA Outcomes
Brief 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
Interventions
None listed
Sponsors
Iqvia Pty Ltd
Apellis Pharmaceuticals, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for patients: * Aged 60 years or over at the time of GA diagnosis * Patients providing informed consent to participate in the study; if the patient is physically incapable of completing the electronic consent form, the form can be completed by a legally acceptable representative of the patient (including an impartial witness, where required) * Patients first diagnosed with GA in at least 1 eye between 3 and 10 years prior to index date * For patients with unilateral GA, the other eye should show signs of AMD (i.e., the non-GA eye should present with at least drusen, reticular pseudodrusen, or wet-AMD) Inclusion criteria for caregivers: * Aged 18 years or over at the time of consent * Caregivers who self-identify as the primary caregiver for a patient for whom documented informed consent for inclusion in the study has been obtained
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in GA total area size | Through study completion; between 4 and 11 years | Mean GA total area size and Mean change in GA total area size |
| Change from baseline in BCVA | Through study completion; between 4 and 11 years | Mean BCVA and Mean change in BCVA |
| Percentage of participants with visual impairment/blindness | Through study completion; between 4 and 11 years | Percentage of participants with moderate/severe visual impairment or blindness |
| Percentage of participants with microperimetry assessment | Through study completion; between 4 and 11 years | Percentage of participants with any microperimetry assessments since GA diagnosis |
| Mean change in functional parameters in patients with microperimetry assessments | Through study completion; between 4 and 11 years | Mean/Median and Mean change in retinal sensitivity. |
| Percentage of eyes with disease progression | Through study completion; between 4 and 11 years | Percentage of eyes that complete any of the protocol-defined disease progression trajectories and Mean time from GA diagnosis to disease progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assisted-care patient journey | From enrollment until end of follow-up; 12 (+6) months after the follow-up period. | Proportion of patients requiring support from an informal caregiver, receiving assisted care at home or in assisted living |
| Proportion of GA eyes with presence of selected characteristics | Through study completion; between 4 and 11 years | Proportion of GA eyes with presence of any of the following: nAMD, drusen, pseudodrusen, foveal involvement, unifocal/multifocal GA, hypopigmentation |
| Associations between patient characteristics and disease progression/functional outcomes and/or clinical/anatomical/functional outcome measures | Through study completion; between 4 and 11 years | Measures of association such as correlation coefficients, chi-square statistic, and potentially coefficients from multivariate analysis methods characterizing the relationships of interest |
| Financial impact of GA on patients and caregivers | From enrollment until end of follow-up; 12 (+6) months after the follow-up period. | Selected items of the GALTOS survey (including the cost, in the past 12 months, associated to prescriptions, assistive devices, healthcare-related travel, etc.) |
| Proportion of non-GA eyes with presence of AMD | Through study completion; between 4 and 11 years | Proportion of non-GA eyes with presence of any of the following: early/intermediate AMD, nAMD, MNV |
| Mortality rate | From enrollment until end of follow-up; 12 (+6) months after the follow-up period. | Mortality rate during study follow-up |
| GA-related HCRU during the observation period | Through study completion; between 4 and 11 years | Number of medical visits (outpatient, low vision clinic, etc.) |
| Patient-reported HRQoL | From enrollment until end of follow-up; 12 (+6) months after the follow-up period. | Score of the EQ-5D. |
| Patient-reported performance | From enrollment until end of follow-up; 12 (+6) months after the follow-up period. | Scores/answers to the NEI-VFQ-25 questionnaire. |
Countries
Australia, France, Germany, Italy, United Kingdom
Outcome results
None listed