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VOLUME 4 - ISSUE 1

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New Anti-VEGF Trial Results at ARVO 2017: SCORE-2 and CLARITY

 

New feature below: highlighting the "10 Take-away" findings and messages from the Association for Research in Vision and Ophthalmology (ARVO)
 

After participating in this activity, the participant will demonstrate the ability to:
  • Evaluate how recent clinical research into anti-VEGF agents can inform treatment for proliferative diabetic retinopathy and for retinal vein occlusion.
  • Describe how newly available therapies may alter current treatment options for patients with retinal vein occlusion or proliferative diabetic retinopathy.

Guest Faculty Disclosure
Dr. Scott has disclosed that she has served as a member of the Data and Safety Monitoring Committee for a clinical trial sponsored by Thrombogenics.

Dr. Sivaprasad has disclosed that she has served as a consultant for Bayer Corporation, Novartis AG and Roche.

Unlabeled/Unapproved Uses
Dr. Scott has disclosed that her discussion will reference bevacizumab, which, although commonly used in current practice, is not currently FDA approved for treating ocular conditions.

Dr. Sivaprasad has dislcosed that her discussion will reference the unlabeled/unapproved uses of aflibercept.
 

 

MEET THE AUTHORS

 

 

 

 

Ingrid Scott, MD, MPH
Jack and Nancy Turner Professor
  of Ophthalmology
Professor of Public Health Sciences
Penn State College of Medicine
Hershey, Pennsylvania

Sobha Sivaprasad, DM, FRCOphth, FRCS
Consultant Ophthalmologist
Moorfields Eye Hospital University College London
United Kingdom, London

 

 


Release Date: Expiration Date:
June 29, 2017 June 28, 2019

 

 


10 Highlights from ARVO - 2017

Jun Kong, MD and Neil Bressler, MD

1. CLARITY: Randomized Clinical Trial – Proliferative Diabetic Retinopathy: Anti-VEGF with Aflibercept vs. PRP
Sobha Sivaprasad, A Toby Prevost, Joana C Vasconcelos, et al, for the CLARITY Study Group.

DRCR.net Symposium: Monday, May 8, 2017; 2:30-3:45pm Ballroom 2

eOphthalmology Summary: CLARITY, a multicenter, single-masked, non-inferiority trial conducted in the UK, compared 1-year outcomes of intravitreous 2.0-mg aflibercept (n=122) versus panretinal photocoagulation (PRP) (n=109) for proliferative diabetic retinopathy (PDR). Following an initial three monthly injections, a median of one additional injection was given for reactivation of neovascularization based on monthly assessments or additional PRP as needed from week 12 based on every 8-week assessments. At 1 year, the aflibercept arm was four letters (median) superior (P<10.0001) to the PRP arm, with less visual field loss, fewer eyes developing macular edema and fewer eyes undergoing vitrectomy, without safety differences identified. CLARITY, with similar outcomes to results from the DRCR.net Protocol S, confirms that anti-VEGF is a viable alternative to PRP, although compliance with follow-up, cost, and lack of long-term outcomes should be considered.

2. SCORE2: Aflibercept vs. Bevacizumab for Macular Edema due to Central or Hemi-Retinal Vein Occlusion
Ingrid U. Scott, Paul C. VanVeldhuisen, Michael S. Ip, et al, for the SCORE2 Investigator Group

SCORE2 Symposium: Tuesday, May 9, 2017; 2:30-3:45 pm Ballroom 2

eOphthalmology Summary: Given the cost differential and lack of comparative vision outcome data of different anti-VEGF agents for macular edema from retinal vein occlusions, SCORE2 compared repackaged (compounded) 1.25-mg bevacizumab to 2.0-mg aflibercept. Eyes with macular edema from central or hemi-retinal vein occlusion were assigned intravitreous bevacizumab or aflibercept every 4 weeks until the primary outcome at 6 months when the mean visual acuity letter score (approximate Snellen equivalent) improved from 50.7 (20/100) to 69.3 (20/40) in the bevacizumab group and from 50.4 (20/100) to 69.3 (20/40) in the aflibercept group. The bevacizumab group had a lower proportion of eyes with resolution of macular edema; whether this difference affects longer term outcomes may be determined from 1-year results. The SCORE2 group has provided valuable comparative data regarding 6-month visual and anatomic outcomes when using considering anti-VEGF treatment options for macular edema from retinal vein occlusions.

3. SCORE2: Baseline Predictors of Visual Acuity and Retinal Thickness Outcomes in Patients with Central Retinal Vein Occlusion or Hemi-retinal Vein Occlusion
SobhIngrid U. Scott, Paul C. VanVeldhuisen, Michael S. Ip, et al, for the SCORE2 Investigator Group

SCORE2 Symposium: Tuesday, May 9, 2017; 2:30-3:45 pm Ballroom 2

eOphthalmology Summary: Following the primary results of the SCORE2 study, the study group evaluated whether there were baseline factors associated with 6-month visual acuity or retinal thickness outcomes. Younger patient age and worse baseline visual acuity were associated with a greater likelihood of a 6-month visual acuity letter gain of at least 15 (gain of approximately 3 or more lines) among eyes treated with bevacizumab or aflibercept. Aflibercept treatment, higher baseline central retinal thickness, and no prior anti-VEGF therapy were associated with higher odds of macular edema resolution over the 6-month period. These findings may be useful in assessing expected responses following six monthly injections of anti-VEGF agents for treating macular edema due to central or hemi-retinal vein occlusion. However, the analysis did not identify factors that should influence how individual eyes should be treated at this time.

4. Interim Safety Data Comparing Ranibizumab and Panretinal Photocoagulation in Patients with Proliferative Diabetic Retinopathy
Jeffrey G. Gross, Adam R. Glassman, Margaret J. Klein, et al, for the Diabetic Retinopathy Clinical Research Network
DRCR.net Symposium: Monday, May 8, 2017; 2:30-3:45pm Ballroom 2

eOphthalmology Summary: Systemic intravenous anti-VEGF therapy increases the risk of vascular events. Data through the 2-year primary outcome of Protocol S of the Diabetic Retinopathy Clinical Research (DRCR) Network, which compared intravitreous ranibizumab vs panretinal photocoagulation (PRP) for managing proliferative diabetic retinopathy, did not identify any differences in systemic safety outcomes between groups. At the ARVO 2017 Annual Meeting, 4-year interim safety data of Protocol S were reported. Among three of the four prespecified systemic safety outcomes, including all-cause death, serious adverse events and hospitalizations, no differences were found across treatment groups. However, the study noted a trend (P = .10) toward increased Antiplatelet Trialists’ Collaboration-defined arterial thromboembolic events among the bilateral treatment group (one study eye assigned to ranibizumab and one study eye assigned to PRP: 12%), the ranibizumab group (only one study eye, assigned to ranibizumab: 18%), and the prompt PRP group (only one study eye, assigned to PRP: 8%). The results were not sufficiently indicative of an increased risk to warrant discontinuing the ranibizumab treatment as the statistical analysis plan specified that P values less than .01 would be considered statistically significant (to adjust for multiple comparisons). Of note, 50% of the PRP group received ranibizumab for diabetic macular edema during the study; therefore, the prompt PRP group should not be thought of as a treatment group without any ranibizumab exposure. The DRCR Network plans a full safety report on the completion of the 5-year follow-up in 2018.

5. Change in Diabetic Retinopathy through 2 Years Secondary Analysis of a Randomized Clinical Trial Comparing Aflibercept, Bevacizumab, and Ranibizumab
Susan B. Bressler, Danni Liu, Adam R. Glassman, et al, for the Diabetic Retinopathy Clinical Research Network

DRCR.net Symposium: Monday, May 8, 2017; 2:30-3:45pm Ballroom 2

eOphthalmology Summary: The Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol T compared three commonly used anti-VEGF agents—2.0-mg aflibercept, 1.25-mg repackaged (compounded) bevacizumab, and 0.3-mg ranibizumab—for diabetic macular edema (DME). Percentages with diabetic retinopathy severity level improvement were based on centralized grading of annual fundus photographs. Cumulative probabilities for diabetic retinopathy worsening were based on fundus photograph severity level grading or other worsening events such as vitreous hemorrhage or panretinal photocoagulation, through 2 years, without adjustment for multiple outcomes. At 1 and 2 years, approximately one-fifth to one-third of eyes with non-proliferative diabetic retinopathy receiving any of the anti-VEGF agents for DME had improvement in diabetic retinopathy severity level. Less improvement was demonstrated with bevacizumab at 1 year than with aflibercept or ranibizumab, although no differences among the three anti-VEGF agents were identified at 2 years. Aflibercept was associated with more improvement in the smaller subgroup of participants with PDR at baseline. All three anti-VEGF treatments were associated with low rates of worsening of diabetic retinopathy severity levels. These data provide additional outcomes that might be considered when choosing an anti-VEGF agent to treat DME.

6. Incremental Cost-Effectiveness of Intravitreous Ranibizumab Compared with Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
David W. Hutton, Joshua D. Stein, MD, Neil M. Bressler, et al, for the Diabetic Retinopathy Clinical Research Network

DRCR.net Symposium: Monday, May 8, 2017; 2:30-3:45pm Ballroom 2

eOphthalmology Summary: The Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol S randomized clinical trial results suggest that ranibizumab is a reasonable treatment alternative to panretinal photocoagulation (PRP) when managing proliferative diabetic retinopathy (PDR). The relative cost-effectiveness was reported in this talk. Compared with PRP, ranibizumab as given in the clinical trial is within the $50,000/quality-adjusted life-year to $150,000/ quality-adjusted life-year range frequently cited as cost-effective in the United States for eyes presenting with PDR and vision-impairing DME, but not for those with PDR without vision-impairing DME. From a societal perspective, in developed countries such as the United States, ranibizumab through 2 years as an alternative therapy to PRP for PDR with vision-impairing DME at baseline provides clinically relevant benefits and is cost-effective. However, for PDR without vision-impairing DME, PRP is the more cost-effective treatment option through at least 2 years.

7. Incidence and Risk Factors for Neovascular AMD in the Fellow Eye in The Comparison Of AMD Treatment Trials (CATT) Follow-Up Study
Maureen G. Maguire, W. Pan, J. E. Grunwald, et al.

Poster B0298: Monday, May 8, 2017; 3:45-5:30 pm

eOphthalmology Summary: The Comparison of AMD Treatments Trials (CATT) investigators, comparing bevacizumab to ranibizumab for neovascular age-related macular degeneration (nAMD), conducted a prospective follow-up study to describe the incidence and risk factors of neovascular age-related macular degeneration (nAMD) through 5 years in the fellow eye of patients with unilateral nAMD. The incidence of nAMD in the fellow eye per year was approximately 10%. The risk increased with the AREDS Risk Score (1 point for larger drusen, 1 point for hyperpigmentation) in the fellow eye or presence of pseudodrusen in the fellow eye. Characteristics of the study eye including hemorrhage associated with the lesion, elevation of the retinal pigment epithelium and an occult pattern of choroidal neovascularization on fluorescein angiography, also were linked with a higher incidence of nAMD in fellow eyes. However, CHF, ARMS2 and C3 SNP risk alleles did not show any correlations with the incidence of nAMD in fellow eyes.

8. Ranibizumab versus verteporfin photodynamic therapy for myopic choroidal neovascularization: Results from RADIANCE Randomized Clinical Trial
Nathan Steinle, A. Ghanekar, C. Quezada-Ruiz.

Poster B0656: Thursday, May 11, 2017; 11:30-1:45 pm

eOphthalmology Summary: RADIANCE was a phase 3 randomized double-masked clinical trial that compared ranibizumab with verteporfin photodynamic therapy (vPDT) for the treatment of patients with visual impairment caused by myopic choroidal neovascularization (mCNV). Patients were assigned randomly to a visual acuity guided ranibizumab 0.5 mg group (RBZ-VA) or a disease activity guided ranibizumab 0.5 mg group (RBZ-DA) or a vPDT group. Both ranibizumab arms provided superior visual acuity gains compared with vPDT (12.1 letters in RBZ-VA, 12.5 letters in RBZ-DA and 1.4 letters in vPDT) at 3 months and (13.8 letters in RBZ-VA, 14.4 letters in RBZ-DA and 9.3 letters in vPDT) at 12 months after baseline. Best-corrected visual acuity gains were maintained through month 12 in both ranibizumab arms following a median of 2 to 4 injections.

9. PLANET – Randomized Clinical Trial: Aflibercept with and without PDT “Rescue” for Polypoidal Choroidal Vasculopathy
Won Ki Lee, Y. Ogura, T. Iida, et al.

Talk: Monday, May 8, 2017; 9:30-9:45 pm Hall G

eOphthalmology Summary: PLANET was a randomized, double-masked, sham-controlled clinical trial evaluating the efficacy and safety of intravitreous 2.0-mg aflibercept injection compared with aflibercept plus “rescue” photodynamic therapy with verteporfin (vPDT) as needed in patients with polypoidal choroidal vasculopathy (PCV). Rescue therapy could be given if: (1) visual acuity change from baseline was <5 letter gain or between 5 and <1010 letters but investigator judged that PDT would be of benefit, and (2) evidence of “active polyps” on indocyanine green angiography. Following 3 consecutive monthly aflibercept injections, study participants were assigned randomly to aflibercept without or with rescue vPDT as needed. Among 318 study participants, only 5% and 7% of participants at week 12, and only an additional 12% and 14% of participants by week 52 received “rescue” therapy in the sham and vPDT groups, respectively. For the primary endpoint of mean change in visual acuity from baseline, aflibercept with sham rescue vPDT (+10.7 letters) was non-inferior to aflibercept with rescue vPDT (+10.8 letters) at week 52. Absence of any “active polyps” on indocyanine green angiography at 52 weeks was 38.9% and 44.8% in the sham rescue vPDT and rescue vPDT groups, respectively. The incidence of ocular treatment-emergent adverse events also was similar (31.2% vs 29.2%) in the sham rescue vPDT and rescue vPDT groups at week 52. The PLANET study proved that aflibercept is an effective treatment for patients with PCV, with most participants not needing rescue vPDT as defined in this study.

10. EVEREST2 Results: Randomized Clinical Trial of Ranibizumab vs. Ranibizumab Plus verteporfin Photodynamic Therapy in Polypoidal Choroidal Vasculopathy
Colin S. Tan, C. Feller, P. Margaron, T. H. Lim.

Poster A0274– Sunday, May 7, 2017; 1:30-3:15 pm
Posters A080, A085– Sunday, May 7, 2017; 3:15-5:00 pm

eOphthalmology Summary: EVEREST2 study was a 24-month phase IV, double-masked, multicenter study that recruited patients with polypoidal choroidal vasculopathy (PCV) across 42 sites in Asia. Among 322 study participants randomly assigned to 0.5-mg ranibizumab without verteporfin photodynamic therapy (vPDT) or ranibizumab with vPDT, the primary outcome was change in visual acuity from baseline to month 12. Secondary outcomes included “complete polyp regression” assessed by indocyanine green angiography at month 12. Results showed ranibizumab with sham vPDT had a 5.1 letter gain in visual acuity at 12 months, versus an 8.3 letter gain when combined with vPDT. The percentage of patients showing complete polyp regression over 12 months was 33.8% in the ranibizumab with sham vPDT group and 69.7% in the ranibizumab with vPDT group. While these results show superior visual acuity gains for the ranibizumab plus vPDT group over the ranibizumab plus sham vPDT group, additional secondary outcomes (such as percentage of eyes gaining at least 10 or at least 15 letters from baseline) can help highlight the clinical relevance of these differences in mean change from baseline.

 

 

OTHER RESOURCES

 

 

 

Download the podcast transcript

 

 

 

 


PROGRAM DIRECTOR
PROGRAM PLANNER

Neil Bressler, MD
James P. Gills Professor of Ophthalmology Chief of the Retina Division
Wilmer Eye Institute at Johns Hopkins
Baltimore, Maryland

Jun Kong, MD, PhD
Post-Doctoral Clinical Research Fellow
Wilmer Eye Institute Johns Hopkins Hospital
Baltimore, Maryland

 

 

 

 

CME/CE INFORMATION

 

 

ACCREDITATION STATEMENT
Physicians
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the Johns Hopkins University School of Medicine. The Johns Hopkins University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.
 

CREDIT DESIGNATION STATEMENT
Physicians
The Johns Hopkins University School of Medicine designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

POLICY ON SPEAKER AND PROVIDER DISCLOSURE
It is the policy of the Johns Hopkins University School of Medicine and the Institute for Johns Hopkins Nursing that the speaker and provider globally disclose conflicts of interest. The Johns Hopkins University School of Medicine OCME has established policies in place that will identify and resolve all conflicts of interest prior to this educational activity. Detailed disclosure will be made in the instructional materials.

 

INTERNET CME/CE POLICY

DISCLAIMER STATEMENT

STATEMENT OF RESPONSIBILITY

STATEMENT OF NEED
INTENDED AUDIENCE

CONFIDENTIALITY DISCLAIMER FOR CME ACTIVITY PARTICIPANTS

HARDWARE & SOFTWARE REQUIREMENTS

COMPLETE CME INFORMATION

 

 

 

All rights reserved - The Johns Hopkins University School of Medicine. Copyright 2017.

This activity was developed in collaboration with DKBmed.