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MVAinAMD2022
Sponsor study identifier
observational
57
1 country
1
Study Start
May 9, 2022
Actual (reported)Primary Completion
June 30, 2023
Actual (reported)Study Completion
September 30, 2023
Actual (reported)Age-related macular degeneration (AMD) is a complex eye disorder and the most common macular disease affecting millions of aged people in the developed countries, with an estimation that the number of AMD patients will be increased to 196 million in 2020, 288 million in 2040. Vision loss, central scotomas and metamorphopsia are the hallmark signs in patients with macular diseases. Metamorphopsia can be defined as a deformation of seen rectilinear lines due to photoreceptor separation/location and it is a typical but not exclusive sign of retinal disease. The most effective method of treating wet AMD is currently the anti-vascular endothelial growth factor intravitreal injections (anti-VEGF). A further concern is the enormous costs and restriction of human resources that make periodic imaging unfeasible. Therefore, in patients with AMD treated by intravitreal anti-VEGF, monitoring with sensitive psychophysical tools could advance the time for diagnosis of CNV reactivation and enhance the outcome of treatment. For assessment of the visual function, visual acuity and Amsler grid have been the gold standard. The Amsler grid is a simple and noninvasive test effortlessly understood by the patient, consisting of evenly spaced vertical and horizontal lines outlining 400 square, it has been widely adopted as a subjective test for metamorphopsia. However, it also produces high false-negative rate. Moreover, the answer to this test is dichotomous: straight or crooked lines and does not allow for quantification thus, it is problematic to monitor the visual function along the course and to evaluate the effectiveness of treatment with anti-VEGF agents. The M-chart (Inami Co., Tokyo, Japan) is a diagnostic device developed by Matsumoto to quantify the grade of metamorphopsia in patients with various types of macular diseases. The usefulness of M-charts has been already demonstrated in different retinal diseases from macular pucker to BRVO. The aim of this study is to compare the traditional Amsler grid and the M-Charts in evaluating metamorphopsia in patients suffering from wet AMD before and after Anti VEGF injection; and to match it with OCT results.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 27, 2022
Actual (reported)April 12, 2022
Actual (reported)May 9, 2022
Actual (reported)June 30, 2023
Actual (reported)September 30, 2023
Actual (reported)Change in VM
Change in values of Vertical M Charts ( from 0 to 2.0 )
baseline and after 1, 3, 6, 12 months ( 5 measurements)
Change in HM
Change in values of Horizontal M Charts ( from 0 to 2.0)
baseline and after 1, 3, 6, 12 months ( 5 measurements)
Change in Amsler Test
Change in values of this test: Positivity (+) or negativity (-)
baseline and after 1, 3, 6, 12 months ( 5 measurements)
CRT
baseline, after 1, 3, 6, 12 months
Visual Acuity
baseline, after 1, 3, 6, 12 months
OCT morphological parameters
baseline, after 1, 3, 6, 12 months
Case only study: heterogeneous group of patients diagnosed with active maculopathy
Ospedale Santa Croce
Cuneo, Piedmont, 12100, Italy
Wong WL, Su X, Li X, Cheung CM, Klein R, Cheng CY, Wong TY. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014 Feb;2(2):e106-16. doi: 10.1016/S2214-109X(13)70145-1. Epub 2014 Jan 3.
Simunovic MP. METAMORPHOPSIA AND ITS QUANTIFICATION. Retina. 2015 Jul;35(7):1285-91. doi: 10.1097/IAE.0000000000000581.
Silvia Violante, MD
OSCroceCarle, +39 0171 641571
57 participants (actual enrollment reported by the registry).
First Submitted
March 27, 2022
First Posted
April 12, 2022
Study Start
May 9, 2022
Actual (reported)Contact the study team to confirm eligibility.
Campa C, Parodi MB. Anti-Vegf Therapy for Ocular Diseases: Present and Future. Curr Drug Targets. 2020;21(12):1158. doi: 10.2174/138945012112200727153907. No abstract available.
Musa F, Muen WJ, Hancock R, Clark D. Adverse effects of fluorescein angiography in hypertensive and elderly patients. Acta Ophthalmol Scand. 2006 Dec;84(6):740-2. doi: 10.1111/j.1600-0420.2006.00728.x.
Loewenstein A, Malach R, Goldstein M, Leibovitch I, Barak A, Baruch E, Alster Y, Rafaeli O, Avni I, Yassur Y. Replacing the Amsler grid: a new method for monitoring patients with age-related macular degeneration. Ophthalmology. 2003 May;110(5):966-70. doi: 10.1016/S0161-6420(03)00074-5.
Wada I, Yoshida S, Kobayashi Y, Zhou Y, Ishikawa K, Nakao S, Hisatomi T, Ikeda Y, Ishibashi T, Sonoda KH. Quantifying metamorphopsia with M-CHARTS in patients with idiopathic macular hole. Clin Ophthalmol. 2017 Sep 20;11:1719-1726. doi: 10.2147/OPTH.S144981. eCollection 2017.
Nowomiejska K, Oleszczuk A, Brzozowska A, Grzybowski A, Ksiazek K, Maciejewski R, Ksiazek P, Juenemann A, Rejdak R. M-charts as a tool for quantifying metamorphopsia in age-related macular degeneration treated with the bevacizumab injections. BMC Ophthalmol. 2013 Apr 15;13:13. doi: 10.1186/1471-2415-13-13.
Querques G, Querques L, Rafaeli O, Canoui-Poitrine F, Bandello F, Souied EH. Preferential hyperacuity perimeter as a functional tool for monitoring exudative age-related macular degeneration in patients treated by intravitreal ranibizumab. Invest Ophthalmol Vis Sci. 2011 Sep 1;52(9):7012-8. doi: 10.1167/iovs.11-7517.
Schuchard RA. Validity and interpretation of Amsler grid reports. Arch Ophthalmol. 1993 Jun;111(6):776-80. doi: 10.1001/archopht.1993.01090060064024.
Primary Completion
June 30, 2023
Actual (reported)Study Completion
September 30, 2023
Actual (reported)Last Updated
November 2, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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