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Completed

NCT Number: NCT06499571

Geographic Atrophy Long-Terms Outcomes Study

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sydney West Retina, Westmead, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Change from baseline in BCVA

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

    Mean BCVA and Mean change in BCVA

  3. 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

  4. 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

  5. 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 retinal sensitivity.

  6. 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 fixation stability.

  7. 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.

  8. 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

Secondary outcomes

  1. Proportion of GA eyes with presence of selected characteristics

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

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

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

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

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

  3. Mortality rate

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

    Mortality rate during study follow-up

  4. GA-related HCRU during the observation period

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

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

  5. GA-related HCRU during the observation period

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

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

  6. GA-related HCRU during the observation period

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

    number of prescribed vision aids, per participant

  7. Patient-reported HRQoL

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

    Score of the EQ-5D.

  8. Patient-reported HRQoL

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

    Score of the HADS

  9. Patient-reported HRQoL

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

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

  10. Patient-reported performance

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

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

  11. Patient-reported performance

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

    Scores/answers to the GALTOS survey.

  12. Assisted-care patient journey

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

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

  13. Assisted-care patient journey

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

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

  14. Financial impact of GA on patients and caregivers

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

Apellis Pharmaceuticals, Inc.

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study 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

Acronym: GALTOS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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