Healio
Healio
April 29, 2013
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Monthly ranibizumab beneficial in treatment of recalcitrant neovascular AMD

Patients with recalcitrant neovascular age-related macular degeneration achieved visual and anatomic gains out to 1 year after receiving monthly doses of 2 mg ranibizumab, according to a recent trial.

Perspective from Michael W. Stewart, MD

The phase 1-2 super-dose anti-VEGF trial, or SAVE, included 88 patients with recalcitrant neovascular AMD who were categorized into two groups after three initial monthly injections of 2 mg Lucentis (ranibizumab, Genentech): cohort A received 2 mg ranibizumab as need every 4 weeks, and cohort B received the same treatment as needed every 6 weeks.

Results were available for 79 patients, among which cohort A received a mean of 11.6 treatments, and cohort B received a mean of 8.6 treatments.

Spectral domain optical coherence tomography demonstrated similar anatomic improvements between both cohorts, including reduced intraretinal and subretinal fluid with three monthly treatments; however, cohort B showed a gradual increase in mean central retinal thickness at 10 months (P = .03).

Both cohorts achieved and maintained best corrected visual acuity with a mean gain of 4.1 letters at 1-year follow-up.

There were no ocular or systemic safety concerns associated with the 2 mg dosing, according to the study authors.

Perspective

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Michael W. Stewart, MD
Michael W. Stewart, MD
Wykoff et al have shown that high dose (2 mg) ranibizumab dries the macula and improves the vision in eyes that respond incompletely to monthly ranibizumab 0.5 mg. I believe that the higher dose prolonged the anti-VEGF effect in a group of patients for whom the 0.5 mg dose produced a measurable clinical effect that was less than 4 weeks in duration. Had these patients been examined 2 or 3 weeks after 0.5 mg injections, they would probably have shown a clinical response. However, unfavorable pharmacokinetic behavior, poor drug penetration through the retina, or relatively high levels of other (non-VEGF) inflammatory cytokines results in these eyes being not just “incomplete responders” but also “brief responders.” Genentech has decided not to further develop the 2 mg dose; therefore, physicians who are confronted with brief responders to ranibizumab or bevacizumab will need to consider administering a higher drug volume (more than 0.05 mL), increasing the frequency of administration, or switching to aflibercept.
Michael W. Stewart, MD
Associate Professor and Chairman of Ophthalmology
Mayo Clinic, Jacksonville, Fla.
Disclosures: Stewart is on the advisory board for Allergan and Regeneron and is a consultant for Boehringer-Ingelheim.
Sources/Disclosures

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Source:

Ophthalmic Surg Lasers Imaging Retina. 2013;44(2):121-126.