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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
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
Trial website
https://clinicaltrials.gov/study/NCT06499571
Trial related presentations / publications
Fleckenstein M, Mitchell P, Freund KB, Sadda S, Holz FG, Brittain C, Henry EC, Ferrara D. The Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration. Ophthalmology. 2018 Mar;125(3):369-390. doi: 10.1016/j.ophtha.2017.08.038. Epub 2017 Oct 27.
Sacconi R, Corbelli E, Querques L, Bandello F, Querques G. A Review of Current and Future Management of Geographic Atrophy. Ophthalmol Ther. 2017 Jun;6(1):69-77. doi: 10.1007/s40123-017-0086-6. Epub 2017 Apr 8.
Kandasamy R, Wickremasinghe S, Guymer R. New Treatment Modalities for Geographic Atrophy. Asia Pac J Ophthalmol (Phila). 2017 Nov-Dec;6(6):508-513. doi: 10.22608/APO.2017262. Epub 2017 Sep 14.
Nielsen, MK. Geographic Atrophy. Eyewiki. 2021. Available from: https://eyewiki.org/Geographic_Atrophy.
Sastre-Ibanez M, Barreiro-Gonzalez A, Gallego-Pinazo R, Dolz-Marco R, Garcia-Armendariz B. Geographic atrophy: Etiopathogenesis and current therapies. Arch Soc Esp Oftalmol (Engl Ed). 2018 Jan;93(1):22-34. doi: 10.1016/j.oftal.2017.07.004. Epub 2017 Sep 5. English, Spanish.
Boyer DS, Schmidt-Erfurth U, van Lookeren Campagne M, Henry EC, Brittain C. THE PATHOPHYSIOLOGY OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION AND THE COMPLEMENT PATHWAY AS A THERAPEUTIC TARGET. Retina. 2017 May;37(5):819-835. doi: 10.1097/IAE.0000000000001392.
Kim A, Devine B, Campbell J, Shirneshan E, Zhao C, Bansal A. Healthcare Resource Utilization and Costs in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration. Clin Ophthalmol. 2021 Jun 23;15:2643-2651. doi: 10.2147/OPTH.S307603. eCollection 2021.
Daien V, Nguyen V, Essex RW, Guymer R, Arnold JJ, Munk M, Ceklic L, Gillies MC, Barthelmes D; Fight Retinal Blindness! investigators. Prevalence and characteristics of macular atrophy in eyes with neovascular age-related macular degeneration. A study from a long-term observational dataset: the Fight Retinal Blindness! project. Br J Ophthalmol. 2020 Aug;104(8):1064-1069. doi: 10.1136/bjophthalmol-2019-315055. Epub 2019 Dec 16.
Sakurada Y, Yoneyama S, Sugiyama A, Tanabe N, Kikushima W, Mabuchi F, Kume A, Kubota T, Iijima H. Prevalence and Genetic Characteristics of Geographic Atrophy among Elderly Japanese with Age-Related Macular Degeneration. PLoS One. 2016 Feb 26;11(2):e0149978. doi: 10.1371/journal.pone.0149978. eCollection 2016.
Patnaik J, Pecen P, Lynch A, Siringo F, Mathias M, Mandava N. The National Eye Institute Visual Function Questionnaire-25 in Patients with Age-Related Macular Degeneration and Controls. Invest Ophthalmol Vis Sci. 2019;60(9):67-.
Sivaprasad S, Tschosik E, Kapre A, Varma R, Bressler NM, Kimel M, Dolan C, Silverman D. Reliability and Construct Validity of the NEI VFQ-25 in a Subset of Patients With Geographic Atrophy From the Phase 2 Mahalo Study. Am J Ophthalmol. 2018 Jun;190:1-8. doi: 10.1016/j.ajo.2018.03.006. Epub 2018 Mar 10.
Patel PJ, Ziemssen F, Ng E, Muthutantri A, Silverman D, Tschosik EA, Cantrell RA. Burden of Illness in Geographic Atrophy: A Study of Vision-Related Quality of Life and Health Care Resource Use. Clin Ophthalmol. 2020 Jan 8;14:15-28. doi: 10.2147/OPTH.S226425. eCollection 2020.
Sivaprasad S, Tschosik EA, Guymer RH, Kapre A, Suner IJ, Joussen AM, Lanzetta P, Ferrara D. Living with Geographic Atrophy: An Ethnographic Study. Ophthalmol Ther. 2019 Mar;8(1):115-124. doi: 10.1007/s40123-019-0160-3. Epub 2019 Jan 31.
Higgins BE, Taylor DJ, Bi W, Binns AM, Crabb DP. Novel computer-based assessments of everyday visual function in people with age-related macular degeneration. PLoS One. 2020 Dec 7;15(12):e0243578. doi: 10.1371/journal.pone.0243578. eCollection 2020.
Singh RP, Patel SS, Nielsen JS, Schmier JK, Rajput Y. Patient-, caregiver-, and eye care professional-reported burden of geographic atrophy secondary to age-related macular degeneration. Am J Ophthalmic Clin Trials. 2019;2(1):1-6. Available from: https://doi.org/10.25259/AJOCT-9-2018
Richard AJ, Duker JS, Reichel E. Geographic atrophy: where we are now and where we are going. Curr Opin Ophthalmol. 2021 May 1;32(3):247-252. doi: 10.1097/ICU.0000000000000763.
Halawa OA, Lin JB, Miller JW, Vavvas DG. A Review of Completed and Ongoing Complement Inhibitor Trials for Geographic Atrophy Secondary to Age-Related Macular Degeneration. J Clin Med. 2021 Jun 11;10(12):2580. doi: 10.3390/jcm10122580.
Sunness JS, Margalit E, Srikumaran D, Applegate CA, Tian Y, Perry D, Hawkins BS, Bressler NM. The long-term natural history of geographic atrophy from age-related macular degeneration: enlargement of atrophy and implications for interventional clinical trials. Ophthalmology. 2007 Feb;114(2):271-7. doi: 10.1016/j.ophtha.2006.09.016.
Chakravarthy U, Bailey CC, Johnston RL, McKibbin M, Khan RS, Mahmood S, Downey L, Dhingra N, Brand C, Brittain CJ, Willis JR, Rabhi S, Muthutantri A, Cantrell RA. Characterizing Disease Burden and Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration. Ophthalmology. 2018 Jun;125(6):842-849. doi: 10.1016/j.ophtha.2017.11.036. Epub 2018 Feb 1.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06499571