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JAMA Ophthalmol. 2019 Apr 1;137(4):372-379. doi: 10.1001/jamaophthalmol.2018.6776.

Effect of Ranibizumab and Aflibercept on Best-Corrected Visual Acuity in Treat-and-Extend for Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial.

Author information

1
Macular Research Group, Save Sight Institute, The University of Sydney, Sydney Eye Hospital, Sydney, New South Wales, Australia.
2
Retina Associates, Chatswood, New South Wales, Australia.
3
Marsden Eye Specialists, Parramatta, New South Wales, Australia.
4
Center for Eye Research Australia, Royal Victorian Eye and Ear Hospital and Ophthalmology, Department of Surgery, University of Melbourne, Victoria, Australia.
5
Department Ophthalmology, Inselspital, University Hospital, University of Bern, Bern, Switzerland.
6
Outlook Eye Specialists, Southport, Queensland, Australia.
7
Healthcare Professionals Group Pty Ltd, Sydney, New South Wales, Australia.
8
Center for Ophthalmology and Visual Science, Lions Eye Institute, The University of Western Australia, Perth, Western Australia, Australia.

Abstract

Importance:

To our knowledge, this is the first randomized clinical trial to compare visual outcomes and injection loads between ranibizumab and aflibercept using an identical treat-and-extend (TE) regimen for neovascular age-related macular degeneration (nAMD).

Objective:

To report the results of the preplanned 12-month interim analysis of 2 predefined secondary efficacy end points of a randomized clinical trial.

Design, Setting, and Participants:

The Comparison of Ranibizumab and Aflibercept for the Development of Geographic Atrophy in (Wet) AMD Patients (RIVAL) trial was conducted in 24 sites in Australia and included 281 treatment-naive eyes from 281 participants with active choroidal neovascularization secondary to nAMD and a visual acuity letter score of 23 or greater who were recruited between April 11, 2014, and October 31, 2015. A preplanned interim analysis was performed at month 12. Best-corrected visual acuity (BCVA) assessors and the central reading center, which determined treatment intervals, were masked to treatment assignments.

Interventions:

Participants were randomized (1:1) to receive intravitreal injections of 0.5 mg of ranibizumab or 2.0 mg of aflibercept. After receiving 3 initial monthly injections, participants entered the TE phase.

Main Outcomes and Measures:

Mean change in BCVA and the number of injections from baseline to month 12.

Results:

Of 281 participants, 148 (52.7%) were women and the mean (SD) age was 77.7 (8.1) years. The baseline mean BCVA letter score (approximate Snellen equivalent) was 65.3 (20/50) in the ranibizumab arm and 65.1 (20/50) in the aflibercept arm. One hundred twenty-seven ranibizumab participants (90.1%) and 121 aflibercept participants (88.3%) completed month 12 with a mean (SD [Snellen equivalent]) BCVA letter score of 72.9 (15.5 [20/32]) and 70.5 (14.6 [20/40]), respectively. The mean change in BCVA letter scores from baseline to month 12 was 7.2 (95% CI, 5.5-8.9) for ranibizumab and 4.9 (95% CI, 3.1-6.6) for aflibercept (letter score difference, 2.3; 95% CI, -0.1 to 4.7; Pā€‰=ā€‰.06). The mean number of injections from baseline to month 12 was 9.7 in both the ranibizumab (SD, 2.8) and aflibercept (SD, 2.6) arms with a rate ratio of 1.00 (95% CI, 1.0-1.1; Pā€‰=ā€‰.86).

Conclusions and Relevance:

Our findings suggest that neither aflibercept nor ranibizumab for nAMD are superior to the other regarding the average visual acuity gains and number of injections during 1 year in a TE regimen. Further follow-up to 2 years may determine if advantages of one over the other can be identified.

Trial Registration:

Clinicaltrials.Gov identifier: NCT02130024.

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