Canadian Treat-and-Extend Analysis Trial with Ranibizumab in Patients with Neovascular Age-Related Macular Disease: One-Year Results of the Randomized Canadian Treat-and-Extend Analysis Trial with Ranibizumab Study.

Peter J Kertes, Ivan J Galic, Mark Greve, R Geoff Williams, Emmanouil Rampakakis, Andrea Scarino, Tom Sheidow

Journal: Ophthalmology 2020;126(6):841-848

PMID: 30677465

Free Full Text on Elsevier Science View on PubMed

Abstract

PURPOSE

To compare the efficacy of ranibizumab using a treat-and-extend (T&E) regimen with monthly dosing in treatment-naive patients with neovascular age-related macular degeneration (nAMD).

DESIGN

Prospective, randomized, open-label, multicenter, noninferiority, postauthorization study.

PARTICIPANTS

Treatment-naive patients with choroidal neovascularization secondary to AMD.

METHODS

Patients with nAMD were randomized 1:1 to receive intravitreal ranibizumab at a dose of 0.5 mg in either a T&E or monthly dosing regimen. The noninferiority of T&E compared with the monthly dosing regimen was to be shown using a margin of 5 letters in best-corrected visual acuity (BCVA) improvement.

MAIN OUTCOME MEASURES

Mean change in BCVA in Early Treatment Diabetic Retinopathy Study letters from baseline to month 12.

RESULTS

Baseline and 12-month visual acuity data are available for 526 patients (T&E, n = 268; monthly, n = 258). At baseline, mean age was 78.8 years (standard deviation [SD], 7.8 years), 60.3% were women, and 94.3% were white. No significant between-group baseline differences were observed. The primary outcome of noninferiority regarding visual acuity was met with mean BCVA improvement of 8.4 letters (SD, 11.9 letters) and 6.0 letters (SD, 11.9 letters; P = 0.017) in the T&E and monthly regimens, respectively, with a between-group mean difference of 2.38 letters (95% confidence interval, 0.32-4.45 letters). Per protocol, a secondary analysis was performed to test for superiority of number of injections received up to month 12. This analysis demonstrated significantly fewer injections with T&E versus monthly dosing (9.4 and 11.8 injections, respectively), with a mean difference of -2.46 injections (95% confidence interval, -2.68 to -2.23 injections).

CONCLUSIONS

The 12-month results of this 2-year study demonstrated that regarding visual outcomes, the T&E regimen was noninferior to a monthly dosing regimen. Similar visual outcomes in the T&E group as in the monthly dosing group were achieved with significantly fewer injections.

Address: The John and Liz Tory Eye Centre, Sunnybrook Health Sciences Center, and University of Toronto, Toronto, Canada. Electronic address: [email protected].; Montreal Retina Institute, and McGill University, Montreal, Canada.; Alberta Retina Consultants, and University of Alberta, Edmonton, Canada.; Calgary Retina Consultants, and University of Calgary, Calgary, Canada.; JSS Medical Research, Saint-Laurent, Canada.; Novartis Pharmaceuticals Canada, Dorval, Canada.; Ivey Eye Institute, and Western University, London, Canada.

DOI: 10.1016/j.ophtha.2019.01.013