Ciulla Thomas Visual Acuity Outcomes - The Retina Society
Transcript of Ciulla Thomas Visual Acuity Outcomes - The Retina Society
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Thomas A Ciulla, MD, MBA
Volunteer Clinical Professor, Indiana University
Retina Society 2020
Visual Acuity Outcomes and Anti-VEGF Intensity in Macular Edema due to RVO:
A “Real World” Analysis in 12,214 Eyes
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• Clearside Bio: Employment, Equity• This project was unsponsored/unfunded, and conducted in my role as
Volunteer Clinical Professor at Indiana University.
Financial Disclosure
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1. ”Real world” RVO patients experience a modest gain in VA2. Injection frequency plays a large role in VA outcomes.3. Better baseline VA increases risk of VA loss• Inverse relationship between outcomes and baseline VA• Reflects a ceiling effect
4. VA gain at 1 year worse than RCTs• For BRVO, ~8 vs ~18 letters in ranibizumab and aflibercept registration trials• For CRVO, ~7 vs ~16 letters in ranibizumab and aflibercept registration trials
5. “Real world” RVO patients experience greater 1-year gain than “real world”AMD and DME patients• However, there is a larger gap in visual gain when compared to respective RCTs
SummaryUS Real World RVO Outcomes
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Vestrum Health Retina Database
• EMR from 100s of US retina MDs• Demographically & geographically diverse• >800,000 patients, >4.5M encounters
”Real World” Experience with Anti-VEGF for RVO-ME in the US
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How Does Treatment intensity affect outcomes?
Eligibility CriteriaTreatment naïve RVO-related macular edema2013 to 2019Must have received at least 1 injectionFollow up data through 1 yearOther retinal diagnoses excluded
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BRVO CRVO
# of Patient Eyes 6,914 5,300
Female 56% 51%
Mean Age (years) 72.3 72.9Mean Baseline VA(letters, Snellen equiv) 56.6, 20/80 39.5, 20/160
Baseline FeaturesBRVO and CRVO
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BRVO CRVO
Mean # Anti-VEGF Injections 7.4 7.6Additional therapies, %
IVT corticosteroids 9% 9%
Focal laser 12% 2%
Panretinal laser 3% 6%
Mean Change VA (letters) +8.1 +7.1
P-Value < 0.001 < 0.001
95% Confidence Interval +7.6 to +8.6 +6.3 to +8.0
Top line results – 1 yearBRVO and CRVO
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Change in VA (letters) vs Injections Over 1 YearBRVO and CRVO
Mean gain at 1 year with 95% confidence interval
# Injections in First Year
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# Injections in First Year
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Patients receive similar # injections regardless of baseline VA, BRVO and CRVO
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BRVO 1 yr CRVO 1 yr
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BRVO 1 yr CRVO 6 mosMea
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Patients receive similar # injections regardless of baseline VA, but those with worse baseline VA gain more VA
BRVO and CRVO
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Real World Analysis Bravo Vibrant
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Bevacizumab Ranibizumab Aflibercept
Anti-VEGF for RVO-Related Macular Edema1-Year VA Change: Real World Analysis vs RCTs
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Real WorldAnalysis
Cruise Copernicus Galileo
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Real World Analysis Bravo Vibrant02468
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Cruise Copernicus Galileo
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CATT View 1 View 2 Anchor Marina02468
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DRCRProtocol T
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Anti-VEGF for BRVO-ME, CRVO-ME, DME, nAMD1-Year VA Change: Real World Analysis vs RCTs
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1. ”Real world” RVO patients experience a modest gain in VA2. Injection frequency plays a large role in VA outcomes.3. Better baseline VA increases risk of VA loss• Inverse relationship between outcomes and baseline VA• Reflects a ceiling effect
4. VA gain at 1 year worse than RCTs• For BRVO, ~8 vs ~18 letters in ranibizumab and aflibercept registration trials• For CRVO, ~7 vs ~16 letters in ranibizumab and aflibercept registration trials
5. “Real world” RVO patients experience greater 1-year gain than “real world”AMD and DME patients• However, there is a larger gap in visual gain when compared to respective RCTs
SummaryUS Real World RVO Outcomes