Abstract
BackgroundTo identify baseline patient characteristics associated with early clinically significant visual acuity (VA) improvements within 3 months of treatment initiation in ranibizumab-treated patients with retinal vein occlusion (RVO) in the SHORE study.MethodsPost hoc analysis of baseline patient characteristics in the randomized, open-label, vision examiner–masked SHORE phase 4 study that compared monthly versus pro re nata dosing of ranibizumab in patients with branch and central RVO. Patients who enrolled in SHORE fulfilled eligibility criteria per protocol (N = 202). SHORE data were retrospectively analyzed to identify baseline patient characteristics associated with early clinically significant improvements in VA, defined as improvement to a Snellen equivalent of 20/40 or better vision (≥ 69 Early Treatment Diabetic Retinopathy Study [ETDRS] letters) or an increase in best-corrected VA (BCVA) of 15 or more ETDRS letters from baseline within 3 months of treatment initiation. Main outcome measures were BCVA gain of 15 or more ETDRS letters from baseline, Snellen equivalent of 20/40 or better vision, and baseline factors associated with early clinically significant improvement in BCVA.ResultsThe median time for patients to achieve a BCVA of 20/40 or better was 59 days and the median time for patients to gain 15 or more ETDRS letters was 63 days. Better baseline BCVA (> 50 ETDRS letters/Snellen equivalent ≥ 20/100), greater baseline total macular volume (> 9.99 mm3), and presence of subretinal fluid at baseline were all associated with early improvement to 20/40 or better vision (ETDRS equivalent ≥ 69 letters; P < .0001, P = .02, and P = .03, respectively).ConclusionsThis retrospective analysis found that better BCVA, greater total macular volume, and presence of subretinal fluid at baseline were associated with more rapid vision gains. Clinicians may find these helpful when considering the likelihood of achieving early clinically significant VA improvements with ranibizumab in patients with RVO.Trial registrationClinicalTrials.gov NCT01277302.
Highlights
To identify baseline patient characteristics associated with early clinically significant visual acuity (VA) improvements within 3 months of treatment initiation in ranibizumab-treated patients with retinal vein occlusion (RVO) in the SHORE study
RVO is most prevalent in older individuals, it can occur in younger individuals [4], potentially compromising their ability to work and drive
The introduction of anti– vascular endothelial growth factor (VEGF) agents to treat macular edema secondary to RVO was an important advancement for the improvement of visual outcomes in patients with branch RVO (BRVO) and central RVO (CRVO) [5]
Summary
To identify baseline patient characteristics associated with early clinically significant visual acuity (VA) improvements within 3 months of treatment initiation in ranibizumab-treated patients with retinal vein occlusion (RVO) in the SHORE study. The introduction of anti– vascular endothelial growth factor (VEGF) agents to treat macular edema secondary to RVO was an important advancement for the improvement of visual outcomes in patients with BRVO and CRVO [5]. Despite these advances, understanding and identifying the patients who will benefit the most and experience rapid vision improvement from anti-VEGF treatment remains an open and important question. Mean best-corrected VA (BCVA) gains from baseline at month 15 were 21.0 and 18.7 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the ranibizumab PRN and monthly arms, respectively [10]
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