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CompletedNCT06499571GALTOSUpdated Jul 12, 2024

Geographic Atrophy Long-Terms Outcomes Study

An observational study in Geographic Atrophy, sponsored by Apellis Pharmaceuticals, Inc.. Completed at 5 sites in 5 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by Apellis Pharmaceuticals, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
255
Ages
60 Years and older
Sex
All
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Study 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

02

Conditions studied

  • Geographic Atrophy

Keywords

  • GA Outcomes
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In context

Geographic Atrophy

173 studies on the registry are indexed under Geographic Atrophy; 44 are open to participants now.

This study's enrollment of 255 is above the median of 123 across 36 observational studies indexed under Geographic Atrophy.

Browse Geographic Atrophy studies →

Lead sponsor

Apellis Pharmaceuticals, Inc. is the lead sponsor of 28 studies on the registry; 3 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who received a diagnosis of GA between 3 and 10 years prior to enrollment across 22 ophthalmology centers in Australia, Canada, France, Germany, Italy, and UK.

Eligibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
255 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Change from baseline in GA total area size

    Mean GA total area size and Mean change in GA total area size

    Time frame: Through study completion; between 4 and 11 years

  2. Change from baseline in BCVA

    Mean BCVA and Mean change in BCVA

    Time frame: Through study completion; between 4 and 11 years

  3. Percentage of participants with visual impairment/blindness

    Percentage of participants with moderate/severe visual impairment or blindness

    Time frame: Through study completion; between 4 and 11 years

  4. Percentage of participants with microperimetry assessment

    Percentage of participants with any microperimetry assessments since GA diagnosis

    Time frame: Through study completion; between 4 and 11 years

  5. Mean change in functional parameters in patients with microperimetry assessments

    Mean/Median and Mean change in retinal sensitivity.

    Time frame: Through study completion; between 4 and 11 years

  6. Mean change in functional parameters in patients with microperimetry assessments

    Mean/Median and Mean change in fixation stability.

    Time frame: Through study completion; between 4 and 11 years

  7. Mean change in functional parameters in patients with microperimetry assessments

    Mean/Median and Mean change in number of scotoma points.

    Time frame: Through study completion; between 4 and 11 years

  8. Percentage of eyes with disease progression

    Percentage of eyes that complete any of the protocol-defined disease progression trajectories and Mean time from GA diagnosis to disease progression

    Time frame: Through study completion; between 4 and 11 years

Secondary outcomes

  1. Proportion of GA eyes with presence of selected characteristics

    Proportion of GA eyes with presence of any of the following: nAMD, drusen, pseudodrusen, foveal involvement, unifocal/multifocal GA, hypopigmentation

    Time frame: Through study completion; between 4 and 11 years

  2. Proportion of non-GA eyes with presence of AMD

    Proportion of non-GA eyes with presence of any of the following: early/intermediate AMD, nAMD, MNV

    Time frame: Through study completion; between 4 and 11 years

  3. Mortality rate

    Mortality rate during study follow-up

    Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.

  4. GA-related HCRU during the observation period

    Number of medical visits (outpatient, low vision clinic, etc.)

    Time frame: Through study completion; between 4 and 11 years

  5. GA-related HCRU during the observation period

    number of imaging tests (F, A, FAF, CFP, OCT, OCTA, etc.)

    Time frame: Through study completion; between 4 and 11 years

  6. GA-related HCRU during the observation period

    number of prescribed vision aids, per participant

    Time frame: Through study completion; between 4 and 11 years

  7. Patient-reported HRQoL

    Score of the EQ-5D.

    Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.

  8. Patient-reported HRQoL

    Score of the HADS

    Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.

  9. Patient-reported HRQoL

    Score of the AQoL-7D for Australian sites only.

    Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.

  10. Patient-reported performance

    Scores/answers to the NEI-VFQ-25 questionnaire.

    Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.

  11. Patient-reported performance

    Scores/answers to the GALTOS survey.

    Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.

  12. Assisted-care patient journey

    Proportion of patients requiring support from an informal caregiver, receiving assisted care at home or in assisted living

    Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.

  13. Assisted-care patient journey

    mean/median time from GA diagnosis to first type of assistance

    Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.

  14. Financial impact of GA on patients and caregivers

    Selected items of the GALTOS survey (including the cost, in the past 12 months, associated to prescriptions, assistive devices, healthcare-related travel, etc.)

    Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.

  15. Associations between patient characteristics and disease progression/functional outcomes and/or clinical/anatomical/functional outcome measures

    Measures of association such as correlation coefficients, chi-square statistic, and potentially coefficients from multivariate analysis methods characterizing the relationships of interest

    Time frame: Through study completion; between 4 and 11 years

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Study locations

5 sites
  • Sydney West Retina
    Westmead, New South Wales NSW 2145, Australia
  • Centre Hospitalier de la Croix Rousse
    Lyon Cedex 04, Rhone 69004, France
  • Universitaetsklinikum Muenster
    Münster, Nordrhein Westfalen 48149, Germany
  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
    Milano, 20157, Italy
  • Belfast Health & SC Trust
    Belfast, BT14 6AB, United Kingdom
08

References and documents

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. PubMed 29110945 ↗
  • 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. PubMed 28391446 ↗
  • 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. PubMed 28905539 ↗
  • 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. PubMed 28886928 ↗
  • 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. PubMed 27902638 ↗
  • 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. PubMed 34188442 ↗
  • 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. PubMed 31843790 ↗
  • 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. PubMed 26918864 ↗
  • 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. PubMed 29530781 ↗
  • 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. PubMed 32021065 ↗
  • 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. PubMed 30706242 ↗
  • 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. PubMed 33284855 ↗
  • 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. PubMed 33741759 ↗
  • 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. PubMed 34208067 ↗
  • 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. PubMed 17270676 ↗
  • 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. PubMed 29366564 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06499571
Lead sponsor
Apellis Pharmaceuticals, Inc.
Collaborators
Iqvia Pty Ltd
Responsible party
Sponsor
First posted
Jul 12, 2024
Start date
Sep 1, 2022
Primary completion
Jul 31, 2023
Completion
Jul 31, 2023
Last update
Jul 12, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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