August 29, 2013
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Monthly, PRN doses of ranibizumab similarly effective in RVO

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TORONTO — As-needed and monthly ranibizumab dosing regimens yielded similar visual acuity gains in patients with retinal vein occlusion who reached a stable disease state, according to results of the SHORE study presented here.

The study compared efficacy of monthly and as-needed (PRN) dosing of intravitreal Lucentis (ranibizumab 0.5 mg, Genentech) in patients with retinal vein occlusion.

“PRN treatment with ranibizumab in vein occlusion after reaching a stable disease state provides visual acuity gains comparable to monthly dosing over a 15-month period in retinal vein occlusion,” Dennis Marcus, MD, said at the American Society of Retina Specialists meeting.

Dennis Marcus

The BRAVO and CRUISE studies did not show the appropriate time to switch from fixed monthly dosing to monthly or PRN dosing, Marcus said. Patients in the SHORE study were switched after 6 months, after stabilization of their disease state, he said.

The SHORE study included 202 patients with branch and central retinal vein occlusion with macular edema who received seven ranibizumab injections over 6 months.

Patients with stable visual acuity and anatomic signs were randomized to receive monthly or PRN injections from month 7 to 15; 171 patients were randomized: 85 to monthly dosing and 86 to PRN dosing. Thirty-one patients were not randomized.

Patients in the monthly dosing group received a mean of 7.9 injections and those in the PRN group received 3.7 injections.

Visual gains obtained during the initial 7-month dosing period were maintained up to 15 months in both groups. Patients in the monthly dosing group gained 19 letters and those in the PRN group gained 23 letters.

More than 70% of patients in each group attained BCVA of 20/40 or better.

Macular thinning was slightly greater in the monthly dosing group than in the PRN group.

No major complications or systemic adverse events were reported, Marcus said.

Disclosure: Marcus receives consulting fees, research support or honoraria from Acucela, Alcon, Allergan, Genentech, GSK, Lpath, Regeneron and ThromboGenics.