Proportion of Patients in VIVID and VISTA with ≥ 2 -Step Improvement in DRSS VIVID VISTA 40% 33.8% 33.3% 35% 29.1% Laser 27.7% 30% 25% Aflibercept 2q4 20% 14.3% Aflibercept 2q8 15% 10% 7.5% 5% n=80 n=81 n=83 n=154 n=151 n=154 0% P <0.0001 Aflibercept 2q4 vs. laser P <0.0001 Aflibercept 2q4 vs. laser P =0.0006 Aflibercept 2q8 vs. laser P =0.0017 Aflibercept 2q8 vs. laser DRSS: Diabetic Retinopathy Severity Score Korobelnik JF, et al. Ophthalmology . 2014;121(11):2247-54 Compared to baseline; LOCF
Change from Baseline in ETDRS DR Severity Level at Month 24 of RISE/RIDE Trials Sham (n=239) 100 Study eyes Ranibizumab 0.3 mg (n=234) Ranibizumab 0.5 mg (n=234) 75 *P < .001 vs. Sham % of eyes ** P < .05 vs.Sham 37.2* 50 35.9* 25 14.5* 13.2* 9.6 5.4 5.0 2.1* 1.3** 1.7* 1.3 0.9** 0 ≥ 3 steps worsening ≥ 2 steps worsening ≥ 2 steps improvement ≥ 3 steps improvement Sham (n=231) 100 Fellow eyes Ranibizumab 0.3 mg (n=228) Vertical bars are 95% Ranibizumab 0.5 mg (n=222) confidence intervals 75 (unadjusted). Study eye P % of eyes values versus sham adjusted for baseline study eye visual 50 acuity ( 55, > 55 letters), baseline HbA1c ( 8%, > 8%), 25 11.7 11.8 and study eye prior treatment 8.1 8.2 7.7 5.7 6.6 5.0 4.3 for DME (yes, no) (Cochran- 2.6 0.9 0.5 Mantel-Haenszel chi-squared 0 test). Fellow eye P values ≥ 3 steps worsening ≥ 2 steps worsening ≥ 2 steps improvement ≥ 3 steps improvement versus sham are unadjusted. Ip M, et al. Archives of Ophthalmology. 2012;130:1145-52.
DRCR Protocol S Primary objective: VA at 2 years in eyes with PDR that receive anti-VEGF therapy with deferred PRP vs. standard prompt PRP therapy. Treatment + deferred: • 0.5 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria • PRP deferred until failure/futility criteria for intravitreal injection are met Standard: • Prompt Panretinal Photocoagulation Target enrollment: 316; Primary completion date targeted Feb. 2015; Study completion targeted Dec. 2017 Ip M, et al. Archives of Ophthalmology. 2012;130:1145-52.
At 5 Years: Patients Continued to Maintain Improvement in Diabetic Retinopathy with PRN Ranibizumab Improvement of ETDRS DR Severity Level 100 Sham/laser crossover to 0.5 mg RBZ 0.3 mg RBZ 0.5 mg RBZ Percent of Patients 90 80 70 60 49 50 43 40 40 33 32 30 21 20 19 20 12 11 8 10 3 0 ≥2 steps ≥3 steps ≥2 steps ≥3 steps n=83 n=33 n=62 n=18 Month 36 Month 60 Sophie R, et al. Am J Ophthalmo l. 2013;156(4):693-705.
IOP Safety Parameters in MEAD Study Eyes Overall, 36% of DEX implant 0.7-mg patients and 5.1% of sham patients had AEs related to elevated IOP or glaucoma during the study DEX Implant DEX Implant Sham Parameter 0.7 mg (n=347) 0.35 mg (n=343) (n=350) IOP at any visit during the study, % (n) IOP ≥ 25 mm Hg 32.0 (111) 27.4 (94) 4.3 (15) IOP ≥ 35 mm Hg 6.6 (23) 5.2 (18) 0.9 (3) Increase of IOP ≥ 10 mm Hg 27.7 (96) 24.8 (85) 3.7 (13) from baseline Use of IOP-lowering medication, % (n) 41.5 (144) 37.6 (129) 9.1 (32) Boyer D, et al. Ophthalmology. 2014;121(10):1904-14.
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