Geographic AtrophyGALTOSNCT06499571
Geographic Atrophy Long-Terms Outcomes Study
An observational study of Geographic Atrophy, run by Apellis Pharmaceuticals, Inc. at 5 sites in 5 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Geographic Atrophy
- How many people
- 255 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Sep 2022to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
- 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
Who cannot join
- 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)
- 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
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Germany1 site
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, 48149
Italy1 site
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milan, 20157
About this study
Official 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
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
- Conditions
- Geographic Atrophy
- Keywords
- GA Outcomes
- Medical subject headings
- Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in GA total area size
Mean GA total area size and Mean change in GA total area size
Measured: Through study completion; between 4 and 11 years
Change from baseline in BCVA
Mean BCVA and Mean change in BCVA
Measured: Through study completion; between 4 and 11 years
Percentage of participants with visual impairment/blindness
Percentage of participants with moderate/severe visual impairment or blindness
Measured: Through study completion; between 4 and 11 years
Percentage of participants with microperimetry assessment
Percentage of participants with any microperimetry assessments since GA diagnosis
Measured: Through study completion; between 4 and 11 years
Mean change in functional parameters in patients with microperimetry assessments
Mean/Median and Mean change in retinal sensitivity.
Measured: Through study completion; between 4 and 11 years
Mean change in functional parameters in patients with microperimetry assessments
Mean/Median and Mean change in fixation stability.
Measured: Through study completion; between 4 and 11 years
Mean change in functional parameters in patients with microperimetry assessments
Mean/Median and Mean change in number of scotoma points.
Measured: Through study completion; between 4 and 11 years
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
Measured: Through study completion; between 4 and 11 years
Secondary outcomes (15)
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
Measured: Through study completion; between 4 and 11 years
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
Measured: Through study completion; between 4 and 11 years
Mortality rate
Mortality rate during study follow-up
Measured: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
GA-related HCRU during the observation period
Number of medical visits (outpatient, low vision clinic, etc.)
Measured: Through study completion; between 4 and 11 years
GA-related HCRU during the observation period
number of imaging tests (F, A, FAF, CFP, OCT, OCTA, etc.)
Measured: Through study completion; between 4 and 11 years
GA-related HCRU during the observation period
number of prescribed vision aids, per participant
Measured: Through study completion; between 4 and 11 years
Patient-reported HRQoL
Score of the EQ-5D.
Measured: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Patient-reported HRQoL
Score of the HADS
Measured: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Patient-reported HRQoL
Score of the AQoL-7D for Australian sites only.
Measured: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Patient-reported performance
Scores/answers to the NEI-VFQ-25 questionnaire.
Measured: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Patient-reported performance
Scores/answers to the GALTOS survey.
Measured: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Assisted-care patient journey
Proportion of patients requiring support from an informal caregiver, receiving assisted care at home or in assisted living
Measured: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Assisted-care patient journey
mean/median time from GA diagnosis to first type of assistance
Measured: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
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.)
Measured: 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
Measures of association such as correlation coefficients, chi-square statistic, and potentially coefficients from multivariate analysis methods characterizing the relationships of interest
Measured: Through study completion; between 4 and 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Sep 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apellis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499571
- Sponsor's protocol ID
- GAL-21-NIS
- Acronym
- GALTOS
- Status last verified
- Jul 2024
- First submitted
- 23 Apr 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 29110945Sacconi 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 28391446Kandasamy 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 28905539Nielsen, 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 28886928Boyer 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 27902638Kim 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 34188442Daien 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 31843790Sakurada 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 26918864Patnaik 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 29530781Patel 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 32021065Sivaprasad 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 30706242Higgins 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 33284855Singh 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06499571
- Acronym / sponsor ID
- GALTOS / GAL-21-NIS
- Conditions
- Geographic Atrophy
- Keywords
- GA Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Apellis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
- Aged 18 years or over at the time of consent
Key exclusion criteria (7 listed)
- 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)
- Caregivers for whom documented informed consent has not been obtained for participation in the GALTOS survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Change from baseline in BCVA
Time frame: Through study completion; between 4 and 11 years
Mean BCVA and Mean change in BCVA
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
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
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.
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.
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.
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
15 secondary outcomes
Proportion of GA eyes with presence of selected characteristics
Time frame: 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
Mortality rate
Time frame: 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
GA-related HCRU during the observation period
Time frame: 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
Patient-reported HRQoL
Time frame: 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.
Patient-reported HRQoL
Time frame: 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.
Patient-reported performance
Time frame: 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.
Assisted-care patient journey
Time frame: 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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Background: PubMed 29110945Fleckenstein 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.
- Background: PubMed 28391446Sacconi 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.
- Background: PubMed 28905539Kandasamy 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.
- BackgroundNielsen, MK. Geographic Atrophy. Eyewiki. 2021. Available from: https://eyewiki.org/Geographic_Atrophy.
- Background: PubMed 28886928Sastre-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.
- Background: PubMed 27902638Boyer 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.
- Background: PubMed 34188442Kim 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.
- Background: PubMed 31843790Daien 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.
- Background: PubMed 26918864Sakurada 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.
- BackgroundPatnaik 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-.
- Background: PubMed 29530781Sivaprasad 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.
- Background: PubMed 32021065Patel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geographic Atrophy, run by Apellis Pharmaceuticals, Inc. at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, France, Germany, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in GA total area size (time frame: Through study completion; between 4 and 11 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06499571, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.