Status:
COMPLETED
Geographic Atrophy Long-Terms Outcomes Study
Lead Sponsor:
Apellis Pharmaceuticals, Inc.
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Geographic Atrophy
Eligibility:
All Genders
60+ years
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 Practi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT06499571
Start Date
September 1 2022
End Date
July 31 2023
Last Update
July 12 2024
Active Locations (5)
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1
Sydney West Retina
Westmead, New South Wales, Australia, NSW 2145
2
Centre Hospitalier de la Croix Rousse
Lyon, Rhone, France, 69004
3
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, Germany, 48149
4
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milan, Italy, 20157