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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06499571




Registration number
NCT06499571
Ethics application status
Date submitted
23/04/2024
Date registered
12/07/2024
Date last updated
12/07/2024

Titles & IDs
Public title
Geographic Atrophy Long-Terms Outcomes Study
Scientific 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
Secondary ID [1] 0 0
GAL-21-NIS
Universal Trial Number (UTN)
Trial acronym
GALTOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cohort 1 - Geographic Atrophy (GA ) : GA (both eyes with GA)

Cohort 2 - GA : nAMD (1 eye with GA; the other eye with nAMD, including MNV)

Cohort 3 - 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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in GA total area size
Timepoint [1] 0 0
Through study completion; between 4 and 11 years
Primary outcome [2] 0 0
Change from baseline in BCVA
Timepoint [2] 0 0
Through study completion; between 4 and 11 years
Primary outcome [3] 0 0
Percentage of participants with visual impairment/blindness
Timepoint [3] 0 0
Through study completion; between 4 and 11 years
Primary outcome [4] 0 0
Percentage of participants with microperimetry assessment
Timepoint [4] 0 0
Through study completion; between 4 and 11 years
Primary outcome [5] 0 0
Mean change in functional parameters in patients with microperimetry assessments
Timepoint [5] 0 0
Through study completion; between 4 and 11 years
Primary outcome [6] 0 0
Mean change in functional parameters in patients with microperimetry assessments
Timepoint [6] 0 0
Through study completion; between 4 and 11 years
Primary outcome [7] 0 0
Mean change in functional parameters in patients with microperimetry assessments
Timepoint [7] 0 0
Through study completion; between 4 and 11 years
Primary outcome [8] 0 0
Percentage of eyes with disease progression
Timepoint [8] 0 0
Through study completion; between 4 and 11 years
Secondary outcome [1] 0 0
Proportion of GA eyes with presence of selected characteristics
Timepoint [1] 0 0
Through study completion; between 4 and 11 years
Secondary outcome [2] 0 0
Proportion of non-GA eyes with presence of AMD
Timepoint [2] 0 0
Through study completion; between 4 and 11 years
Secondary outcome [3] 0 0
Mortality rate
Timepoint [3] 0 0
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Secondary outcome [4] 0 0
GA-related HCRU during the observation period
Timepoint [4] 0 0
Through study completion; between 4 and 11 years
Secondary outcome [5] 0 0
GA-related HCRU during the observation period
Timepoint [5] 0 0
Through study completion; between 4 and 11 years
Secondary outcome [6] 0 0
GA-related HCRU during the observation period
Timepoint [6] 0 0
Through study completion; between 4 and 11 years
Secondary outcome [7] 0 0
Patient-reported HRQoL
Timepoint [7] 0 0
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Secondary outcome [8] 0 0
Patient-reported HRQoL
Timepoint [8] 0 0
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Secondary outcome [9] 0 0
Patient-reported HRQoL
Timepoint [9] 0 0
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Secondary outcome [10] 0 0
Patient-reported performance
Timepoint [10] 0 0
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Secondary outcome [11] 0 0
Patient-reported performance
Timepoint [11] 0 0
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Secondary outcome [12] 0 0
Assisted-care patient journey
Timepoint [12] 0 0
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Secondary outcome [13] 0 0
Assisted-care patient journey
Timepoint [13] 0 0
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Secondary outcome [14] 0 0
Financial impact of GA on patients and caregivers
Timepoint [14] 0 0
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Secondary outcome [15] 0 0
Associations between patient characteristics and disease progression/functional outcomes and/or clinical/anatomical/functional outcome measures
Timepoint [15] 0 0
Through study completion; between 4 and 11 years

Eligibility
Key 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
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2023
Sample size
Target
Accrual to date
Final
255
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney West Retina - Westmead
Recruitment postcode(s) [1] 0 0
NSW 2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Rhone
Country [2] 0 0
Germany
State/province [2] 0 0
Nordrhein Westfalen
Country [3] 0 0
Italy
State/province [3] 0 0
Milano
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Belfast

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Apellis Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Iqvia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06499571