Geographic Atrophy Long-Terms Outcomes Study (GALTOS)

July 11, 2024 updated by: Apellis Pharmaceuticals, Inc.

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

255

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion; between 4 and 11 years
Change from baseline in BCVA
Time Frame: Through study completion; between 4 and 11 years
Mean BCVA and Mean change in BCVA
Through study completion; between 4 and 11 years
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
Through study completion; between 4 and 11 years
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
Through study completion; between 4 and 11 years
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.
Through study completion; between 4 and 11 years
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.
Through study completion; between 4 and 11 years
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.
Through study completion; between 4 and 11 years
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
Through study completion; between 4 and 11 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion; between 4 and 11 years
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
Through study completion; between 4 and 11 years
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
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
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.)
Through study completion; between 4 and 11 years
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.)
Through study completion; between 4 and 11 years
GA-related HCRU during the observation period
Time Frame: Through study completion; between 4 and 11 years
number of prescribed vision aids, per participant
Through study completion; between 4 and 11 years
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.
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Patient-reported HRQoL
Time Frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Score of the HADS
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
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.
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
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.
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
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.
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
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
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
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
From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
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.)
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
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
Through study completion; between 4 and 11 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apellis Pharmaceuticals, Inc.

Collaborators

IQVIA Pty Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAL-21-NIS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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