Retinal Physician

JAN-FEB 2017

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45 R E T I N A L P H Y S I C I A N | N O V E M B E R / D E C E M B E R 2 0 1 6 45 R E T I N A L P H Y S I C I A N . C O M | J A N U A R Y / F E B R U A R Y 2 0 1 7 PRN, based on pre-defined criteria. At month 48, 11.2% and 7.6% of patients in the 0.3- mg and 0.5-mg ranibizumab groups, respectively, achieved ≥3-step DRSS improvement vs only 4.8% in the sham group with ranibizumab crossover. A ≥2-step DRSS wors- ening occurred in approximately 2.5% of patients in the ranibizumab groups vs 11.3% in the sham/crossover group. Patients originally randomized to ranibizumab had a lower risk of developing a new PDR event compared with patients originally randomized to sham, and these results persisted through month 54. 9 ese data suggested that early, frequent anti-VEGF was essential to halting, and in many cases reversing, DR progression. Data Protocol I from the was a prospective, random- ized trial comparing sham plus focal laser (S+FL), triam- cinolone plus prompt focal laser (T+pFL), and anti-VEGF (ranibizumab) with either prompt (R+pFL) or deferred focal laser (R+dFL) for patients with center-involved DME. 3 Patients in the injection arms of the trial received monthly injections through week 12 and then were assigned to receive additional injections, based on strictly defined criteria. To assess DR progression, the researchers had the cohort separated into patients with and without PDR at the time of randomization. 4 For patients without PDR, at 36 months, 7%, 18%, 23%, and 37% of patients had worsening in the R+dFL, R+pFL, S+FL, and T+pFL groups, respectively. For patients with PDR at randomization, 18%, 21%, 40%, and 12% had worsening in the R+dFL, R+pFL, S+FL, and T+pFL groups, respectively. Eyes assigned to R+dFL, R+pFL, or T+pFL had decreased rates of vitreous hemorrhage and were less likely to require panretinal photocoagulation, compared to patients in the S+FL group. ese data again showed the protective effect of ranibizumab against DR progression. More recently, the group released data comparing ranibizumab to PRP for high-risk PDR. 10 With two years of follow-up, they found ranibizumab to be noninferior to PRP for the management of PDR in terms of VA change. Eyes with inactive or regressed neovascularization at two years were not significantly different between the groups, providing additional evidence that ranibizumab halts DR progression in many patients with PDR at baseline. Data presented at the 2016 Retina Society meeting Table 1. Trials Demonstrating Superiority of Anti-VEGF TRIAL OUTCOME MEASURES (PARTIAL LIST) RIDE and RISE 1 BCVA improvement of ≥15 ETDRS letters Anatomic improvement (OCT, clinical findings) DR progression assessed via the early treatment diabetic retinopathy study (ETDRS) DRSS Occurrence of a new PDR event 2 protocoI 3 BCVA improvement of ≥10 ETDRS letters Central retinal thickness (OCT) DR progression (7-field color stereoscopic images obtained at baseline and 12 months) Development of PDR, ≥2 step ETDRS DR score worsening, needing PRP, development of vitreous hemorrhage, and requiring surgery for PDR 4 VISTA and VIVID 5 Mean change in BCVA, including proportion of eyes gaining ≥15 ETDRS letters Proportion of eyes with a ≥2 step improvement in the DRSS Protocol B 6 Visual acuity assessed via ETDRS letters Central retinal thickness (OCT) MEAD 7 Percentage of patients achieving ≥15 ETDRS letters Central retinal thickness (OCT) FAME 8 Percentage of patients achieving ≥15 ETDRS letters Central retinal thickness (OCT) ≥2 step DRSS improvement

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