Alternative treatments to inhibit VEGF in age-related choroidal neovascularisation: 2-year findings of the IVAN randomised controlled trial
Open accessAbstract
BACKGROUND: Bevacizumab has been suggested to have similar effectiveness to ranibizumab for treatment of neovascular age-related macular degeneration. The Inhibition of VEGF in Age-related choroidal Neovascularisation (IVAN) trial was designed to compare these drugs and different regimens. Here, we report the findings at the prespecified 2-year timepoint. METHODS: In a multicentre, 2×2 factorial, non-inferiority randomised trial, we enrolled adults aged at least 50 years with active, previously untreated neovascular age-related macular degeneration and a best corrected distance visual acuity (BCVA) of at least 25 letters from 23 hospitals in the UK. Participants were randomly assigned (1:1:1:1) to intravitreal injections of ranibizumab (0·5 mg) or bevacizumab (1·25 mg) in continuous (every month) or discontinuous (as needed) regimens, with monthly review. Study participants and clinical assessors were masked to drug allocation. Allocation to continuous or discontinuous treatment was masked up to 3 months, at which point investigators and participants were unmasked. The primary outcome was BCVA at 2 years, with a prespecified non-inferiority limit of 3·5 letters. The primary safety outcome was arterial thrombotic event or hospital admission for heart failure. Analyses were by modified intention to treat. This trial is registered, number ISRCTN92166560. FINDINGS: Between March 27, 2008, and Oct 15, 2010, 628 patients underwent randomisation. 18 were withdrawn; 610 received study drugs (314 ranibizumab; 296 bevacizumab) and were included in analyses. 525 participants reached the visit at 2 years: 134 ranibizumab in continuous regimen, 137 ranibizumab in discontinuous regimen, 127 bevacizumab in continuous regimen, and 127 bevacizumab in discontinuous regimen. For BCVA, bevacizumab was neither non-inferior nor inferior to ranibizumab (mean difference -1·37 letters, 95% CI -3·75 to 1·01; p=0·26). Discontinuous treatment was neither non-inferior nor inferior to continuous treatment (-1·63 letters, -4·01 to 0·75; p=0·18). Frequency of arterial thrombotic events or hospital admission for heart failure did not differ between groups given ranibizumab (20 [6%] of 314 participants) and bevacizumab (12 [4%] of 296; odds ratio [OR] 1·69, 95% CI 0·80-3·57; p=0·16), or those given continuous (12 [4%] of 308) and discontinuous treatment (20 [7%] of 302; 0·56, 0·27-1·19; p=0·13). Mortality was lower with continuous than discontinuous treatment (OR 0·47, 95% CI 0·22-1·03; p=0·05), but did not differ by drug group (0·96, 0·46-2·02; p=0·91). INTERPRETATION: Ranibizumab and bevacizumab have similar efficacy. Reduction in the frequency of retreatment resulted in a small loss of efficacy irrespective of drug. Safety was worse when treatment was administered discontinuously. These findings highlight that the choice of anti-VEGF treatment strategy is less straightforward than previously thought. FUNDING: UK National Institute for Health Research Health Technology Assessment programme.
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In the IVAN study, the incidence of geographic atrophy was similar in eyes treated with ranibizumab (28%) and bevacizumab (31%; p=0.46).
“However, in the IVAN study, the incidence was similar in eyes treated with ranibizumab (28%) and with bevacizumab (31%; p=0.46)”
From Five-Year Outcomes with Anti–Vascular Endothelial Growth Factor Treatment of Neovascular Age-Related Macular Degeneration (2016) · cites this paper as [9]
In CATT and all randomized trials of anti-VEGF treatment for neovascular AMD, most improvement in mean visual acuity from baseline occurred within the first 3 to 6 months, with little erosion of benefit through 2 years when a fixed monthly or bi-monthly schedule was maintained.
“In CATT and all randomized clinical trials of anti-VEGF treatment for neovascular AMD, most of the improvement in mean visual acuity from baseline occurred within the first 3 to 6 months with little erosion of the benefit through 2 years when a fixed schedule of monthly (ranibizumab, bevacizumab, aflibercept) or bi-monthly (aflibercept) treatment was maintained.1,7,9,17,34”
From Five-Year Outcomes with Anti–Vascular Endothelial Growth Factor Treatment of Neovascular Age-Related Macular Degeneration (2016) · cites this paper as [9]
The similar incidence in IVAN decreases the likelihood of a true effect of ranibizumab on geographic atrophy development.
“decreasing the likelihood of a true effect of ranibizumab on development of geographic atrophy.”
From Five-Year Outcomes with Anti–Vascular Endothelial Growth Factor Treatment of Neovascular Age-Related Macular Degeneration (2016) · cites this paper as [9]
In the IVAN study, 34% of eyes that received continuous monthly treatment developed geographic atrophy compared with 26% in the discontinuous PRN group (p=0.03).
“In the IVAN study, 34% of eyes that received continuous (monthly) treatment developed geographic atrophy as compared with 26% in the discontinuous (PRN) group (p=0.03).9”
From Five-Year Outcomes with Anti–Vascular Endothelial Growth Factor Treatment of Neovascular Age-Related Macular Degeneration (2016) · cites this paper as [9]
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BackgroundMyopic choroidal neovascularisation: current concepts and update on clinical management
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Dual Antagonism of PDGF and VEGF in Neovascular Age-Related Macular Degeneration
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BackgroundReticular pseudodrusen: A critical phenotype in age-related macular degeneration
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“…groups at week 52 were 11.0, 13.1, 9.7, and 12.0 letters for different dosing regimens (0.5mg every 4weeks, 2mg every 4weeks, 2mg every 8weeks after 3 initial monthly doses, and 2mg as needed after 3 initial monthly doses, resp.) versus −1.3 letters for the laser group (𝑃 ≤ 0.0001 versus laser).”
BackgroundInfluentialManagement of pseudophakic cystoid macular edema
Guo, S., Patel, S. N., Baumrind, B. R., Johnson, K. S., Levinsohn, D., Marcus, E., Tannen, B. L., Roy, M. S., Bhagat, N., & Zarbin, M. A. (2014) · Survey of Ophthalmology · doi:10.1016/j.survophthal.2014.08.005 · Cited by 119 · see citing works
Age-Related Macular Degeneration
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“Psychometric evaluation was later conducted in the Inhibit VEGF in Age-related Choroidal Neovascularisation (IVAN) clinical trial (Chakravarthy et al., 2012, 2013).”
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Anatomic Clinical Trial Endpoints for Nonexudative Age-Related Macular Degeneration
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Macular Atrophy in Neovascular Age-Related Macular Degeneration
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“141 139 Yes 1 (1) 1 (1) No 8 (6) 8 (6) N/A 132 (93) 130 (93) Inner subfield, no.”
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“The frequency of arterial thrombotic events and the overall safety profile were similar in both groups [32].”
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“26).(17) The bevacizumab group had a mean gain of 4.”
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“The formation of macular atrophy after anti-VEGF therapy was confirmed in the CATT and IVAN trials after 2 years, and in these trials, the monthly dosing groups had a higher incidence of macular atrophy compared with the discontinuous treatment groups.(25,43,44) While this observation has raised questions about whethe…”
ResultRosenberg, D., Deonarain, D. M., Gould, J., Sothivannan, A., Phillips, M., Sarohia, G. S., Sivaprasad, S., Wykoff, C. C., Cheung, C. M. G., Sarraf, D., et al. (2022) · Eye · doi:10.1038/s41433-022-02020-7 · Cited by 90 · see citing works
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“At the end of 2 years, the risk of developing geographic atrophy was reported as 34% with monthly injections versus 26% with PRN administration [16].”
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Endothelial Progenitor Cells in Diabetic Retinopathy
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Dakin, H., Wordsworth, S., Rogers, C. A., Abangma, G., Raftery, J. P., Harding, S. P., Lotery, A. J., Downes, S. M., Chakravarthy, U., Reeves, B. C., et al. (2014) · BMJ Open · doi:10.1136/bmjopen-2014-005094 · Cited by 85 · see citing works
“and bevacizumab produced similar improvements in visual function, with no significant difference in arteriothrombotic events or hospital admissions for heart failure, which have previously been linked with anti-VEGF therapy.(5) IVAN also compared discontinuous (as-needed) treatment against continuous monthly injec-”
Self-citationIntravitreal injections: past trends and future projections within a UK tertiary hospital
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“Consistent with the results of CATT, IVAN and MANTA studies, the mean treatment outcome with bevacizumab showed slightly less gain in BCVA, but of a magnitude that can be regarded as clinically insignificant [4,6,7].”
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The Emerging Regulation of VEGFR-2 in Triple-Negative Breast Cancer
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AIF-independent parthanatos in the pathogenesis of dry age-related macular degeneration
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“Collectively, we report that AIF-independent PARP-1-dependent necrosis constitutes a major mechanism of RPE cell death leading to retinal degeneration in dry AMD.”
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Martin, D. F. (2018) · American Journal of Ophthalmology · doi:10.1016/j.ajo.2017.12.019 · Cited by 76 · see citing works
- Authors
- Chakravarthy, U., Harding, S. P., Rogers, C. A., Downes, S. M., Lotery, A. J., Culliford, L. A., & Reeves, B. C.
- Affiliations
- Queen's University Belfast (GB)
- Corresponding author
- Chakravarthy, Usha
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2013-10
- Volume
- 382
- Issue
- 9900
- Pages
- 1258-1267
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2154073405
- Cited by
- 748
- References
- 45
- Citations by year
- 2026: 13 · 2025: 36 · 2024: 36 · 2023: 36 · 2022: 33 · 2021: 84 · 2020: 66 · 2019: 44 · 2018: 74 · 2017: 66 · 2016: 90 · 2015: 77 · 2014: 75 · 2013: 13
- FWCI
- 84.02
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The Lancet (publishedVersion, cc-by-nc-sa)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion)
- Research Portal (Queen's University Belfast) (submittedVersion, cc-by-nc-sa)
- Bristol Research (University of Bristol) (submittedVersion, cc-by-nc-sa)
- ePrints Soton (University of Southampton) (submittedVersion, cc-by-nc-sa)
- Funders
- National Institute for Health and Care Research (07/36/01)
- Health Technology Assessment Programme (07/36/01, /36/01)
- Topics
- Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
- Health Sciences › Medicine › Ophthalmology › Ocular Diseases and Behçet’s Syndrome
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Retinal and Macular Surgery
- Keywords
- neovascular age-related macular degeneration, choroidal neovascularization, bevacizumab, ranibizumab, anti-VEGF therapy, intravitreal injection, treatment regimen comparison, best-corrected visual acuity, non-inferiority, arterial thrombotic events, long-term outcomes
- MeSH terms
- Bevacizumab, Ranibizumab, Aged, Female, Humans, Male, Middle Aged, Treatment Outcome, Choroidal Neovascularization, Angiogenesis Inhibitors, Vascular Endothelial Growth Factor A, Antibodies, Monoclonal, Humanized
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