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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 255
- Locations
- 5
- Primary Endpoint
- Change from baseline in BCVA
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
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
Outcomes
Primary Outcomes
Change from baseline in BCVA
Time Frame: Through study completion; between 4 and 11 years
Mean BCVA and Mean change in BCVA
Percentage of participants with microperimetry assessment
Time Frame: Through study completion; between 4 and 11 years
Percentage of participants with any microperimetry assessments since GA diagnosis
Percentage of eyes with disease progression
Time Frame: 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
Change from baseline in GA total area size
Time Frame: Through study completion; between 4 and 11 years
Mean GA total area size and Mean change in GA total area size
Percentage of participants with visual impairment/blindness
Time Frame: Through study completion; between 4 and 11 years
Percentage of participants with moderate/severe visual impairment or blindness
Mean change in functional parameters in patients with microperimetry assessments
Time Frame: Through study completion; between 4 and 11 years
Mean/Median and Mean change in number of scotoma points.
Secondary Outcomes
- Proportion of GA eyes with presence of selected characteristics(Through study completion; between 4 and 11 years)
- Proportion of non-GA eyes with presence of AMD(Through study completion; between 4 and 11 years)
- Mortality rate(From enrollment until end of follow-up; 12 (+6) months after the follow-up period.)
- GA-related HCRU during the observation period(Through study completion; between 4 and 11 years)
- Financial impact of GA on patients and caregivers(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(Through study completion; between 4 and 11 years)
- Patient-reported HRQoL(From enrollment until end of follow-up; 12 (+6) months after the follow-up period.)
- Patient-reported performance(From enrollment until end of follow-up; 12 (+6) months after the follow-up period.)
- Assisted-care patient journey(From enrollment until end of follow-up; 12 (+6) months after the follow-up period.)