Geographic Atrophy Long-Terms Outcomes Study

NCT06499571 | Completed

• 1 other identifier: GAL-21-NIS
• Study Type: observational
• Target: 255
• Locations: 5 countries
• Sites: 5

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

Conditions

Geographic Atrophy

Keywords

GA Outcomes

Outcome Measures

Primary Outcomes (8)

• Change from baseline in GA total area size

  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

  Mean BCVA and Mean change in BCVA

  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

  Through study completion; between 4 and 11 years

• Percentage of participants with microperimetry assessment

  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

  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

  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

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

  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

  Through study completion; between 4 and 11 years

Secondary Outcomes (15)

• Proportion of GA eyes with presence of selected characteristics

  Through study completion; between 4 and 11 years

• Proportion of non-GA eyes with presence of AMD

  Through study completion; between 4 and 11 years

• Mortality rate

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

• GA-related HCRU during the observation period

  Through study completion; between 4 and 11 years

• GA-related HCRU during the observation period

  Through study completion; between 4 and 11 years

Study Arms (3)

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Apellis Pharmaceuticals, Inc.: lead
• Iqvia Pty Ltd: collaborator

Study Sites (5)

Sydney West Retina

Westmead, New South Wales, NSW 2145, Australia

Location

Centre Hospitalier de la Croix Rousse

Lyon, Rhone, 69004, France

Location

Universitaetsklinikum Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

Milan, 20157, Italy

Location

Belfast Health & SC Trust

Belfast, BT14 6AB, United Kingdom

Location

Related Publications (19)

• 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.

  PMID: 29110945 BACKGROUND

• 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.

  PMID: 28391446 BACKGROUND

• 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.

  PMID: 28905539 BACKGROUND

• Nielsen, MK. Geographic Atrophy. Eyewiki. 2021. Available from: https://eyewiki.org/Geographic_Atrophy.

  BACKGROUND

• 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.

  PMID: 28886928 BACKGROUND

• 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.

  PMID: 27902638 BACKGROUND

• 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.

  PMID: 34188442 BACKGROUND

• 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.

  PMID: 31843790 BACKGROUND

• 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.

  PMID: 26918864 BACKGROUND

• 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-.

  BACKGROUND

• 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.

  PMID: 29530781 BACKGROUND

• 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.

  PMID: 32021065 BACKGROUND

• 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.

  PMID: 30706242 BACKGROUND

• 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.

  PMID: 33284855 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 33741759 BACKGROUND

• 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.

  PMID: 34208067 BACKGROUND

• 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.

  PMID: 17270676 BACKGROUND

• 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.

  PMID: 29366564 BACKGROUND

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: July 12, 2024
• Study Start: September 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

IT (1); DE (1); GB (1); AU (1); FR (1)