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Intravitreous injection with ranibizumab (Lucentis, Genentech) is well-tolerated, safe, and improves the functional and anatomic status in patients with visual impairment due to choroidal neovascularization (CNV) associated with rare diseases, according to findings from 6 months of follow-up in the phase III MINERVA study.
Seattle-Intravitreous injection with ranibizumab (Lucentis, Genentech) is well-tolerated, safe, and improves the functional and anatomic status in patients with visual impairment due to choroidal neovascularization (CNV) associated with rare diseases, according to findings from 6 months of follow-up in the phase III MINERVA study.
The data were presented by Timothy Lai, MD, honorary clinical associate professor of ophthalmology and visual sciences, Chinese University of Hong Kong, at ARVO 2016.
“CNV is most commonly associated with wet age-related macular degeneration and pathologic myopia, but it can also be idiopathic or occur with many other conditions including uveitis, central serous chorioretinopathy, angioid streaks, trauma, tumor, retinal or macular dystrophies,” he said.
There is currently an unmet medical need and no available approved therapy for the treatment of patients with visual impairment due to CNV associated with these rare diseases. MINERVA is designed to evaluate the efficacy and safety of ranibizumab in these patients, Dr. Lai noted.
MINERVA is a 12-month, double-masked, multicenter study that randomized 178 patients 2:1 to receive ranibizumab 0.5 mg or sham at entry. Patients received a single injection at baseline. They were followed monthly, and all patients became eligible to receive ranibizumab as needed based on the investigator’s assessment of disease activity.
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Patients enrolled in MINERVA were at least 18 years old and had BCVA between 24 and 83 ETDRS letters in the study eye. Baseline and ocular characteristics were well-balanced at entry in the ranibizumab and sham treatment groups. Idiopathic chorioretinopathy was the most common etiology for CNV (35%).
Dr. Lai reported that the primary efficacy endpoint, change from baseline BCVA at month 2, was met with ranibizumab showing a treatment effect of about +10 letters compared with sham (P<0.001).
Subgroup analyses performed with eyes divided into five categories by CNV etiology (angioid streaks, postinflammatory retinochoroidpathy, central serous chorioretinoapthy, idiopathic, and miscellaneous) showed a benefit of ranbizumab regardless of CNV etiology; across the five subgroups, the treatment effect ranged from +5 to +14.5 letters.
Compared with the control group, significantly more patients treated with ranibizumab showed BCVA gains of both 10 or more letters and 15 or more letters from baseline to month 2.
OCT evaluation of central subfield thickness showed a treatment effect of nearly 90 microns at month 2 in the ranibizumab group compared with the sham-treated controls.
In addition, significantly more patients treated with ranibizumab than sham achieved complete resolution of intraretinal or subretinal fluid.
At follow-up to 6 months, patients who were randomized to ranibizumab maintained their functional and anatomic improvements while patients in the sham group, after being allowed to receive ranibizumab, gained BCVA and showed a decrease in central subfield thickness.
No safety concerns emerging during the follow-up to 6 months.