Proportion of Patients in VIVID and VISTA with 2 -Step Improvement - - PowerPoint PPT Presentation

▶

Apr 07, 2023 429 likes •520 views

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

SLIDE 1

SLIDE 2

SLIDE 3

Korobelnik JF, et al. Ophthalmology. 2014;121(11):2247-54

Proportion of Patients in VIVID and VISTA with ≥ 2-Step Improvement in DRSS

DRSS: Diabetic Retinopathy Severity Score Compared to baseline; LOCF

7.5% 14.3% 33.3% 33.8% 27.7% 29.1%

0% 5% 10% 15% 20% 25% 30% 35% 40%

Laser Aflibercept 2q4 Aflibercept 2q8

n=80 n=81 n=83 n=154 n=151 n=154

VIVID VISTA

P<0.0001 Aflibercept 2q4 vs. laser P=0.0006 Aflibercept 2q8 vs. laser P<0.0001 Aflibercept 2q4 vs. laser P=0.0017 Aflibercept 2q8 vs. laser

SLIDE 4

Change from Baseline in ETDRS DR Severity Level at Month 24 of RISE/RIDE Trials

5.0 9.6 5.4 1.3 1.3** 1.7* 37.2* 13.2* 0.9** 2.1* 35.9* 14.5* 25 50 75 100 ≥ 3 steps worsening ≥ 2 steps worsening ≥ 2 steps improvement ≥ 3 steps improvement Sham (n=239) Ranibizumab 0.3 mg (n=234) Ranibizumab 0.5 mg (n=234)

*P < .001 vs. Sham ** P < .05 vs.Sham

Sham (n=231) Ranibizumab 0.3 mg (n=228) Ranibizumab 0.5 mg (n=222) 4.3 11.7 8.2 2.6 5.7 11.8 6.6 0.9 5.0 8.1 7.7 0.5 25 50 75 100 ≥ 3 steps worsening ≥ 2 steps worsening ≥ 2 steps improvement ≥ 3 steps improvement

% of eyes Fellow eyes % of eyes Study eyes

Vertical bars are 95% confidence intervals (unadjusted). Study eye P values versus sham adjusted for baseline study eye visual acuity (55, > 55 letters), baseline HbA1c (8%, > 8%), and study eye prior treatment for DME (yes, no) (Cochran- Mantel-Haenszel chi-squared test). Fellow eye P values versus sham are unadjusted. Ip M, et al. Archives of Ophthalmology. 2012;130:1145-52.

SLIDE 5

DRCR Protocol S

Ip M, et al. Archives of Ophthalmology. 2012;130:1145-52.

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

SLIDE 6

At 5 Years: Patients Continued to Maintain Improvement in Diabetic Retinopathy with PRN Ranibizumab

33 8 20 3 49 21 40 11 43 19 32 12

10 20 30 40 50 60 70 80 90 100

≥2 steps n=83 ≥3 steps n=33 ≥2 steps n=62 ≥3 steps n=18 Sham/laser crossover to 0.5 mg RBZ 0.3 mg RBZ 0.5 mg RBZ

Percent of Patients

Improvement of ETDRS DR Severity Level Month 36 Month 60

Sophie R, et al. Am J Ophthalmol. 2013;156(4):693-705.

SLIDE 7

Boyer D, et al. Ophthalmology. 2014;121(10):1904-14.

Parameter DEX Implant 0.7 mg (n=347) DEX Implant 0.35 mg (n=343) Sham (n=350) IOP at any visit during the study, % (n) IOP ≥ 25 mm Hg IOP ≥ 35 mm Hg Increase of IOP ≥ 10 mm Hg from baseline 32.0 (111) 6.6 (23) 27.7 (96) 27.4 (94) 5.2 (18) 24.8 (85) 4.3 (15) 0.9 (3) 3.7 (13) Use of IOP-lowering medication, % (n) 41.5 (144) 37.6 (129) 9.1 (32)

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

SLIDE 8