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Peter Kertes, Tom Sheidow, Geoff Williams, Mark Greve, Ivan Galic, Jason Baker; Canadian Treat-and-Extend Trial with Ranibizumab in nAMD Patients: CANTREAT 36 Month Anatomic Outcomes. Invest. Ophthalmol. Vis. Sci. 2020;61(7):3501.
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Few large prospective studies have assessed the efficacy of a treat-and-extend (T&E) ranibizumab regimen vs once monthly (OM) dosing for treatment of nAMD. The extension study assessed the long-term effectiveness in those initially randomized to T&E and remaining on T&E vs those initially randomized to OM and switched to T&E at Month 24 for 12 months.
This was a 24 month randomized (1:1 T&E:OM), open label, Canadian, post authorization non inferiority study. Patients completing the 24 month main study were offered a 12 month ranibizumab extension with a T&E regimen for a total of 36 months. ETDRS Best Corrected Visual Acuity (BCVA), injection frequency, OCT morphology, and central retinal thickness (CRT) data are presented for extension patients by treatment group in the main study + extension (T&E vs OM T&E).
The study was approved by ethics boards and an Institutional Review Board. 139 patients (73 T&E: 66 OM T&E) from the main study entered and 121 patients (68 [93.2%] T&E: 53 [80.3%] OM T&E) completed the extension. Demographics and baseline BCVA and CRT were comparable between groups. Mean (SD) changes from baseline in BCVA at Month 36 were 6.3 (11.61) letters for the T&E group and 3.9 (13.91) letters for the OM T&E group. After 36 months, 13.7% of T&E patients gained ≥15 letters vs 6.1% of OM T&E patients; fewer patients experienced losses of ≥15 letters in the T&E (2.7%) vs the OM T&E group (7.6%). During the extension, a mean(SD) of 7.3 (2.73) and 7.1 (2.80) injections were administered in the T&E and OM T&E groups. The percentage of patients with intra- or subretinal fluid in the macula at baseline, Months 12, 24, and 36, in the T&E group vs the OM T&E was 100.0, 24.7, 16.4, and 20.5% vs. 100.0, 25.8, 15.2, and 19.7% respectively. Mean (SD) reductions from baseline in CRT at Months 12, 24, and 36 were 111.8 (118.64), 136.0(127.89), and 127.7(131.23) µm in T&E patients, respectively, vs 107.0 (104.88), 113.3 (107.28), and 115.1 (108.33) µm in OM T&E patients.
After 36 months, mean BCVA improvements achieved at 24 months were maintained for both the patients exclusively treated with the T&E regimen and those that switched to T&E after 24 months of the OM regimen. From baseline to Months 12, 24, and 36, changes in CRT were similar for both treatment arms.
This is a 2020 ARVO Annual Meeting abstract.
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