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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion; between 4 and 11 years |
| Proportion of non-GA eyes with presence of AMD |
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Inclusion Criteria:
Inclusion criteria for patients:
Inclusion criteria for caregivers:
Exclusion Criteria:
Exclusion criteria for patients:
Exclusion criteria for caregivers:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney West Retina | Westmead | New South Wales | NSW 2145 | Australia | ||
| Centre Hospitalier de la Croix Rousse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29110945 | Background | 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. | |
| 28391446 | 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. |
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| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| 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 |
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 | 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 | Number of medical visits (outpatient, low vision clinic, etc.) | 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.) | Through study completion; between 4 and 11 years |
| GA-related HCRU during the observation period | number of prescribed vision aids, per participant | Through study completion; between 4 and 11 years |
| Patient-reported HRQoL | Score of the EQ-5D. | From enrollment until end of follow-up; 12 (+6) months after the follow-up period. |
| Patient-reported HRQoL | Score of the HADS | 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. | 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. | From enrollment until end of follow-up; 12 (+6) months after the follow-up period. |
| Patient-reported performance | 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 | 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 | 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 | 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 | 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 |
| Lyon |
| Rhone |
| 69004 |
| France |
| Universitaetsklinikum Muenster | Münster | North Rhine-Westphalia | 48149 | Germany |
| Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco) | Milan | 20157 | Italy |
| Belfast Health & SC Trust | Belfast | BT14 6AB | United Kingdom |
| 28905539 | 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. |
| Background | Nielsen, MK. Geographic Atrophy. Eyewiki. 2021. Available from: https://eyewiki.org/Geographic_Atrophy. |
| 28886928 | 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. |
| 27902638 | 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. |
| 34188442 | 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. |
| 31843790 | 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. |
| 26918864 | 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. |
| 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-. |
| 29530781 | 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. |
| 32021065 | 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. |
| 30706242 | 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. |
| 33284855 | 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. |
| 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 |
| 33741759 | 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. |
| 34208067 | 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. |
| 17270676 | 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. |
| 29366564 | 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. |