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Flexible Dosing of Ranibizumab Safe, Maintains Efficacy in Age-Related Macular Degeneration: Presented at AAO

By Emma Hitt, PhD

ATLANTA -- November 12, 2008 -- A flexible dosing schedule for ranibizumab maintains efficacy outcomes in treatment-naïve patients with neovascular age-related macular degeneration (AMD), according to research presented at the American Academy of Ophthalmology (AAO) annual meeting.

Frank G. Holz, MD, University of Bonn, Bonn, Germany reported findings from the phase 3b Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (SUSTAIN) here at an oral session on November 11.

SUSTAIN was designed to assess the safety and efficacy of ranibizumab in choroidal neovascularisation secondary to AMD, using a guided, individualised, as-needed, dosing schedule.

The study included 531 individuals who were either ranibizumab-naïve or had completed the Anti-VEGF (vascular endothelial growth factor) Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in AMD (ANCHOR) trial.

The current analysis was a preplanned interim analysis of 69 of the ranibizumab-naïve patients. Patients received 3 fixed monthly injections of either 0.3 or 0.5 mg ranibizumab in the initial phase and then returned every 4 weeks in the maintenance phase for a total study period of 12 months.

Criteria for retreatment in the maintenance phase included visual deterioration greater than 5 letters or a greater than 100-mcm increase in central retinal thickness.

Ocular adverse events occurred in 55.1% of study eyes and were mostly mild in nature, Dr. Holz explained during his presentation. Adverse events included reduced visual acuity, transiently increased intraocular pressure, retinal or conjunctival haemorrhage, and blepharitis. Serious adverse events included a retinal haemorrhage in one patient and retinal pigment epithelium detachment in another patient.

In ranibizumab-naïve patients, visual acuity was maintained over the course of 12 months using guided, individualised, as-needed dosing; there was a decrease from 9.2 letters to 6.7 letters from months 3 to 12, but this difference was not significant. Likewise, the decrease in central retinal thickness was maintained, with a decrease of 89.6 mcm at month 3 and 78.7 mcm at month 12.

The average number of injections given in the initial phase was 3.0 (range: 2 to 3) and 2.3 (range: 0 to 7) in the maintenance phase, indicating that only minimal doses are needed when using a flexible dosing schedule.

At month 3 and month 12, the change in visual acuity from baseline was within 15 letters for approximately 74% and 71% of patients, respectively, indicating that as-needed treatment maintained visual acuity.

"These results suggest that flexible dosing based on predefined treatment criteria with monthly monitoring results in fewer injections overall and can maintain efficacy outcomes," said Dr. Holz.

Funding for this study was provided by Novartis Pharmaceuticals Corporation.


[Presentation title: Flexibly Dosed Ranibizumab in Patients With Neovascular AMD: Twelve-Month Interim Results of the SUSTAIN Trial. Abstract PA078]

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