Geographic Atrophy Long-Terms Outcomes Study (GALTOS)

Apellis Pharmaceuticals

Status: Completed

Conditions: Geographic Atrophy

Study type: Observational

Funder types: Industry

Identifiers

NCT06499571

GAL-21-NIS

Details and patient eligibility

About

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

Enrollment: 255 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

255 participants in 3 patient groups

Cohort 1

Description:

Geographic Atrophy (GA ) : GA (both eyes with GA)

Cohort 2

Description:

GA : nAMD (1 eye with GA; the other eye with nAMD, including MNV)

Cohort 3

Description:

GA : early/intermediate AMD (1 eye with GA; the other eye with early/intermediate AMD) o Other subgroups (GA : drusen, GA : reticular pseudodrusen) will be consider if the sample size allows AMD: Age -Related Macular Degeneration MNV: Macular Neovascularization nAMD: Neovascular Age -Related Macular Degeneration