Geographic Atrophy Long-Terms Outcomes Study

Apellis Pharmaceuticals, Inc.255 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

255

Conditions

Geographic Atrophy

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: Exclusion criteria for patients: * Patients diagnosed with GA due to causes other than AMD (e.g., monogenetic macular dystrophies \[Stargardt disease, other\], toxic maculopathies) in either eye * GA with any concurrent intraocular condition that in the opinion of the treating physician would require surgical or intravitreal intervention (for the prevention or treatment of visual loss) during the study or might impact the interpretation of routine clinical assessments e.g., glaucoma, cataract, proliferative diabetic retinopathy. Patients first diagnosed with GA less than 3 years prior to the date of consent * Patients who have not attended a healthcare institution for the management of GA following diagnosis of GA (a minimum of 2 routine clinical visits for monitoring of GA that included assessment of at least BCVA should be documented in the medical records) * Patients who have been enrolled in an interventional clinical trial in which they received medication for any retinal condition (note: patients with bilateral GA should be excluded only if both eyes received the pharmacological intervention) Exclusion criteria for caregivers: * Caregivers for whom documented informed consent has not been obtained for participation in the GALTOS survey * Caregivers with any significant mental incapacity that would prevent them from participating in the survey * Paid caregivers

Locations (5)

Sydney West Retina

Westmead, New South Wales, Australia

Centre Hospitalier de la Croix Rousse

Lyon, Rhone, France

Universitaetsklinikum Muenster

Münster, North Rhine-Westphalia, Germany

Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

Milan, Italy

Outcomes

Primary Outcomes

Change from baseline in GA total area size

Mean GA total area size and Mean change in GA total area size

Time frame: Through study completion; between 4 and 11 years

Change from baseline in BCVA

Mean BCVA and Mean change in BCVA

Time frame: 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

Time frame: Through study completion; between 4 and 11 years

Percentage of participants with microperimetry assessment

Percentage of participants with any microperimetry assessments since GA diagnosis

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Through study completion; between 4 and 11 years

Percentage of eyes with disease progression

Data from ClinicalTrials.gov

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Secondary Outcomes

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

Time frame: 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

Time frame: Through study completion; between 4 and 11 years

Mortality rate

Mortality rate during study follow-up

Time frame: 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.)

Time frame: 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.)

Time frame: Through study completion; between 4 and 11 years

GA-related HCRU during the observation period

number of prescribed vision aids, per participant

Time frame: Through study completion; between 4 and 11 years

Patient-reported HRQoL

Score of the EQ-5D.

Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.

Patient-reported HRQoL

Score of the HADS

Time frame: 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.

Time frame: 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.

Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.

Patient-reported performance

Scores/answers to the GALTOS survey.

Time frame: 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

Time frame: 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

Time frame: 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.)

Time frame: 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

Time frame: Through study completion; between 4 and 11 years