Clinical trial NCT06499571: Geographic Atrophy Long-Terms Outcomes Study
Official title: G.A.L.T.O.S. Geographic Atrophy Long-Terms Outcomes Study: An Ambispective Noninterventional Study to Describe the Patient Demographics and Outcomes of Patients With Geographic Atrophy (GA) Secondary to AMD in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Geographic Atrophy
Keywords: GA Outcomes
Lead sponsor: Apellis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2024-07-12
Enrollment: 255
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received a diagnosis of GA between 3 and 10 years prior to enrollment across 22 ophthalmology centers in Australia, Canada, France, Germany, Italy, and UK.

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in GA total area size
timeFrame: Through study completion; between 4 and 11 years
measure: Change from baseline in BCVA
timeFrame: Through study completion; between 4 and 11 years
measure: Percentage of participants with visual impairment/blindness
timeFrame: Through study completion; between 4 and 11 years
measure: Percentage of participants with microperimetry assessment
timeFrame: Through study completion; between 4 and 11 years
measure: Mean change in functional parameters in patients with microperimetry assessments
timeFrame: Through study completion; between 4 and 11 years
measure: Mean change in functional parameters in patients with microperimetry assessments
timeFrame: Through study completion; between 4 and 11 years
measure: Mean change in functional parameters in patients with microperimetry assessments
timeFrame: Through study completion; between 4 and 11 years
measure: Percentage of eyes with disease progression
timeFrame: Through study completion; between 4 and 11 years
Secondary outcomes:
measure: Proportion of GA eyes with presence of selected characteristics
timeFrame: Through study completion; between 4 and 11 years
measure: Proportion of non-GA eyes with presence of AMD
timeFrame: Through study completion; between 4 and 11 years
measure: Mortality rate
timeFrame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
measure: GA-related HCRU during the observation period
timeFrame: Through study completion; between 4 and 11 years
measure: GA-related HCRU during the observation period
timeFrame: Through study completion; between 4 and 11 years
measure: GA-related HCRU during the observation period
timeFrame: Through study completion; between 4 and 11 years
measure: Patient-reported HRQoL
timeFrame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
measure: Patient-reported HRQoL
timeFrame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
measure: Patient-reported HRQoL
timeFrame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
measure: Patient-reported performance
timeFrame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
measure: Patient-reported performance
timeFrame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
measure: Assisted-care patient journey
timeFrame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
measure: Assisted-care patient journey
timeFrame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
measure: Financial impact of GA on patients and caregivers
timeFrame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
measure: Associations between patient characteristics and disease progression/functional outcomes and/or clinical/anatomical/functional outcome measures
timeFrame: Through study completion; between 4 and 11 years
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Sydney West Retina
state: New South Wales
city: Lyon Cedex 04
country: France
facility: Centre Hospitalier de la Croix Rousse
state: Rhone
city: Münster
country: Germany
facility: Universitaetsklinikum Muenster
state: Nordrhein Westfalen
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
city: Belfast
country: United Kingdom
facility: Belfast Health & SC Trust
Study officials:
References:
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