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Efficacy and safety of a fixed bimonthly ranibizumab treatment regimen in eyes with neovascular age-related macular degeneration: results from the RABIMO trial

  • Retinal Disorders
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Abstract

Purpose

To evaluate prospectively the efficacy and safety of a fixed bimonthly ranibizumab treatment regimen (RABIMO) in eyes with neovascular age-related macular degeneration (nAMD) and to compare these results with a pro re nata (PRN) treatment scheme.

Methods

This was a 12-month, phase IV, single center, randomised, non-inferiority study. Following three initial monthly injections, patients were randomised to receive either ranibizumab bimonthly (RABIMO group) or ranibizumab PRN (PRN group) (n = 20 each). Main outcome measures were best-corrected visual acuity (BCVA), central retinal thickness (CRT), number of injections, and adverse events (AEs).

Results

BCVA [median (interquartile range, IQR)] increased significantly in both groups after 12 months [RABIMO group +8.5 (14); PRN group +6.5 (16) ETDRS letters] when compared to baseline (p < 0.0001; p = 0.0085). At month 12, the RABIMO treatment regimen was non-inferior to the PRN scheme (∆BCVA = 3.5 ETDRS letters; p < 0.0001). CRT was significantly reduced in both groups after the 12-month study period (p < 0.0001 each), with no significant difference between groups (p = 0.6772). Number of overall injections [median (IQR)] was 8 (0) in the RABIMO versus 4 (5) in the PRN group (p = 0.0037). Three patients in the RABIMO group received one additional unscheduled injection. We observed no significant differences between groups in the number of patients with reported SAEs/AEs (RABIMO group n = 6/15; PRN group n = 7/13) (p = 0.7357/p = 0.4902).

Conclusions

We found no evidence of significant functional or anatomical differences between the RABIMO and PRN treatment regimens. However, the RABIMO group’s number of injections was twice as high as the PRN group’s (protocol-driven). In light of potential side effects, the fixed bimonthly treatment regimen might not be advisable for routine clinical care, but it might be a worthwhile treatment option if monthly monitoring is not possible. Eudra-CT number: 2009-017324-11.

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Acknowledgements

This research project was sponsored by Novartis Pharma GmbH, Nuremberg, Germany. All authors have full control of all primary data and they agree to allow Graefes Archive for Clinical and Experimental Ophthalmology to review their data upon request.

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Correspondence to Nicolas Feltgen.

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Funding

The study was funded by Novartis Pharma GmbH, Germany and is registered with Eudra-CT number: 2009-017324-11. The sponsor or funding organization did not participate in the design of the study, data management, data analysis and interpretation, or preparation, review and, approval of the manuscript.

Financial disclosures

Nicolas Feltgen has received funds from Novartis (Switzerland), Allergan (Ireland), Bayer HealthCare (Germany), and Heidelberg Engineering (Germany).

Thomas Bertelmann has received funding for research and clinical trials from Alcon (USA), Alimera Sciences (USA), Allergan (Ireland), Bayer HealthCare (Germany), and Novartis (Switzerland), as well as consulting fees, honoraria and travel reimbursement from Alcon (USA), Alimera Sciences (USA), Allergan (Ireland), Bayer HealthCare (Germany), and Novartis (Switzerland). He is a scientific staff member of Georg-August-University Goettingen, Germany and was a Medical Advisor for Novartis Pharma GmbH, Nuremberg, Germany from April 2015 till August 2016.

Mirko Bretag, Sebastian Pfeiffer, Reinhard Hilgers, Josep Callizo and Lena Goldammer declare that they have no conflict of interest.

Sebastian Bemme has received funds from Novartis (Switzerland).

Hans Hoerauf has received funds from Alcon (USA), Alimera Sciences (USA), Allergan (Ireland), Bayer HealthCare (Germany), Heidelberg Engineering (Germany) and Novartis (Switzerland).

Ethical approval

“All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.”

Informed consent

“Informed consent was obtained from all individual participants included in the study.”

Additional information

Nicolas Feltgen and Thomas Bertelmann contributed equally to this work.

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Feltgen, N., Bertelmann, T., Bretag, M. et al. Efficacy and safety of a fixed bimonthly ranibizumab treatment regimen in eyes with neovascular age-related macular degeneration: results from the RABIMO trial. Graefes Arch Clin Exp Ophthalmol 255, 923–934 (2017). https://doi.org/10.1007/s00417-017-3589-x

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  • DOI: https://doi.org/10.1007/s00417-017-3589-x

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