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In addition to data from the 2 phase III clinical trials, data from phase I/II studies were also included in the FDA review.  In an open-label, 2-center, uncontrolled, randomized, phase I clinical trial, Rosenfeld and colleagues (2006) examined if multiple intravitreal doses of up to 2 mg of ranibizumab can be tolerated and are biologically active when injected using a dose-escalating strategy in eyes of patients with neovascular AMD.  A total of 32 patients with primary or recurrent sub-foveal choroidal neovascularization secondary to AMD were enrolled.  Baseline best-corrected VA in the study eye was from 20/40 to 20/640 (Snellen equivalent).  Treatment regimens consisted of 5, 7, or 9 intravitreal injections of ranibizumab at 2- or 4-week intervals for 16 weeks, with escalating doses ranging from to mg.  Patients were evaluated through day 140, 4 weeks after their last injection.  Safety was assessed based on ocular and non-ocular adverse events, changes in VA, changes in intraocular pressure (IOP), slit-lamp ocular examination, changes in lesion characteristics based on fluorescein angiography and color fundus photography, and the presence of anti-ranibizumab antibodies.  A total of 29 patients received an injection at baseline, and 27 patients completed the study through day 140.  Results were similar across the 3 treatment groups.  All patients experienced ocular adverse events, most of which were mild.  The most common ocular adverse events were iridocyclitis (83 %), and injection-site reactions (72 %).  Inflammation did not increase with repeated injections, despite the increasing ranibizumab doses.  Transient mild IOP elevations were common after ranibizumab injection.  No serum anti-ranibizumab antibodies were detected.  In general, median and mean VAs in the study eyes improved by day 140 in all 3 groups.  Only 3 of the 27 patients lost significant vision.  There was no significant lesion growth, and a decrease in area of leakage from choroidal neovascularization was detected through day 140.  The authors concluded that multiple intravitreal injections of ranibizumab at escalating doses ranging from to mg were well-tolerated and biologically active in eyes with neovascular AMD through 20 weeks.  Mild transient ocular inflammation was the most common post-injection adverse event.

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  • Citation tools Download this article to citation manager Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE) BMJ 2017; 356 :j1285
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    Dear Sir,
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