Ranibizumab for Neovascular Age-Related Macular Degeneration
Open accessAbstract
BACKGROUND: Ranibizumab--a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A--has been evaluated for the treatment of neovascular age-related macular degeneration. METHODS: In this multicenter, 2-year, double-blind, sham-controlled study, we randomly assigned patients with age-related macular degeneration with either minimally classic or occult (with no classic lesions) choroidal neovascularization to receive 24 monthly intravitreal injections of ranibizumab (either 0.3 mg or 0.5 mg) or sham injections. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. RESULTS: We enrolled 716 patients in the study. At 12 months, 94.5% of the group given 0.3 mg of ranibizumab and 94.6% of those given 0.5 mg lost fewer than 15 letters, as compared with 62.2% of patients receiving sham injections (P<0.001 for both comparisons). Visual acuity improved by 15 or more letters in 24.8% of the 0.3-mg group and 33.8% of the 0.5-mg group, as compared with 5.0% of the sham-injection group (P<0.001 for both doses). Mean increases in visual acuity were 6.5 letters in the 0.3-mg group and 7.2 letters in the 0.5-mg group, as compared with a decrease of 10.4 letters in the sham-injection group (P<0.001 for both comparisons). The benefit in visual acuity was maintained at 24 months. During 24 months, presumed endophthalmitis was identified in five patients (1.0%) and serious uveitis in six patients (1.3%) given ranibizumab. CONCLUSIONS: Intravitreal administration of ranibizumab for 2 years prevented vision loss and improved mean visual acuity, with low rates of serious adverse events, in patients with minimally classic or occult (with no classic lesions) choroidal neovascularization secondary to age-related macular degeneration. (ClinicalTrials.gov number, NCT00056836 [ClinicalTrials.gov].).
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Ranibizumab anti-Fab immunoreactivity in treatment-naïve patients was between 0-0.9% in the MARINA and ANCHOR trials.
“Ranibizumab anti-Fab immunoreactivity in treatment-naïve patients was between 0–0.9% in the MARINA and ANCHOR trials [30, 31].”
From Mechanisms of sterile inflammation after intravitreal injection of antiangiogenic drugs: a narrative review (2021) · cites this paper as [30]
The Adverse Events section reports baseline anti-ranibizumab immunoreactivity of 0% and 0.9% in the two ranibizumab groups of MARINA, before study treatment. The Discussion identifies ANCHOR as a separate trial but does not give its baseline immunoreactivity rates, so this source supports the MARINA portion, not the stated range for both trials. No page numbers were supplied for these passages. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe MARINA and ANCHOR trials with ranibizumab showed an incidence of 0.05% for inflammation.
“The MARINA and ANCHOR trials with ranibizumab showed an incidence of 0.05% [30, 31], and a subsequent comparison study of ranibizumab and bevacizumab for neovascular AMD reported rates of 0.16% for ranibizumab and 0.5% for bevacizumab [32].”
From Mechanisms of sterile inflammation after intravitreal injection of antiangiogenic drugs: a narrative review (2021) · cites this paper as [30]
The Adverse Events section reports 0.05% per injection in MARINA, but that figure is for presumed endophthalmitis, not inflammation generally; Table 2 records ocular inflammation separately. The Discussion mentions ANCHOR but does not give it a 0.05% rate. Page numbers are unavailable in our copy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredRegardless of anti-VEGF agent, pre-treatment ADA titers have not been shown to have any clinically relevant difference in BCVA outcomes.
“Regardless of anti-VEGF agent, pre-treatment ADA titers have not been shown to have any clinically relevant difference in BCVA outcomes [30, 33, 41, 43].”
From Mechanisms of sterile inflammation after intravitreal injection of antiangiogenic drugs: a narrative review (2021) · cites this paper as [30]
The Adverse Events section (page unavailable) reports no clinically relevant differences in efficacy between patients with and without immunoreactivity to ranibizumab. It also reports antibody testing at baseline, but does not establish that pre-treatment ADA titers predict BCVA outcomes, and this study does not assess other anti-VEGF agents. (LLM, conf=0.88)
Experimental — accuracy not yet measuredRepeated intravitreal injections of anti-VEGF therapies effectively slow vision loss in the majority of treatment-compliant patients with wet AMD.
“Repeated intravitreal (IVT) injections of anti-VEGF therapies effectively slow vision loss in the majority of treatment-compliant patients with wet AMD. 7 – 13”
From Design and Characterization of a Novel Intravitreal Dual-Transgene Genetic Medicine for Neovascular Retinopathies (2024) · cites this paper as [12]
The Study Treatment section describes monthly intravitreal ranibizumab injections, and Primary and Secondary End Points reports that 90.0–94.6% of recipients lost fewer than 15 letters at 12 or 24 months, compared with 52.9–62.2% of sham-injection recipients. This supports slowed vision loss for most patients receiving ranibizumab, but this trial alone does not establish the result for anti-VEGF therapies generally or specifically for a treatment-compliant subgroup. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn the ANCHOR and MARINA studies, 8-14% of eyes gained at least 15 letters during months 4 to 12.
“In the ANCHOR and MARINA studies, 8-14% of eyes gained 415 letters during months 4 to 12. [22][23][24]”
From Defining response to anti-VEGF therapies in neovascular AMD (2015) · cites this paper as [22]
The Primary and Secondary End Points section reports that approximately one quarter to one third of ranibizumab-treated patients gained at least 15 letters at 12 months. It does not report an 8–14% gain during months 4 to 12, and this paper reports the MARINA study, not ANCHOR. (LLM, conf=0.83)
Experimental — accuracy not yet measured
The best outcomes with anti-VEGF therapies in n-AMD are achieved with regular dosing at specific intervals, usually monthly, as shown in pivotal ranibizumab trials, and sometimes two-monthly in the first year with aflibercept after three monthly initiation doses.
“It is now accepted that the best outcomes with anti-VEGF therapies in n-AMD are achieved with regular dosing at specific intervals, usually monthly, as demonstrated in the pivotal trials of ranibizumab, and sometimes two monthly in the first year with aflibercept after the ' three monthly initiation doses'.[22][23][24][25]”
From Defining response to anti-VEGF therapies in neovascular AMD (2015) · cites this paper as [22]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredInitial response at month 4 is not always predictive of long-term visual acuity gains, because a proportion of eyes continue to accrue gains after month 4.
“However, this initial response at month 4 is not always predictive of long-term VA gains, as a proportion of such eyes continue to accrue gains in vision even after month 4 as in the ANCHOR and MARINA studies, 22,24 HARBOR study 30 and subsequent case series.31”
From Defining response to anti-VEGF therapies in neovascular AMD (2015) · cites this paper as [22]
Figure 2 and the Primary and Secondary End Points section show that mean visual acuity in ranibizumab-treated groups improved early and remained improved at 12 and 24 months; the plotted group means indicate some further gain after the early months. The paper does not assess whether an individual eye’s month-4 response predicts its long-term gain or report the proportion of eyes that continued to gain after month 4. (LLM, conf=0.82)
Experimental — accuracy not yet measuredMajor anti-VEGF trials other than CATT did not enroll patients with neovascular AMD whose hemorrhage exceeded half of the total CNV lesion.
“Other major anti-VEGF clinical trials excluded such patients.18,19,20”
From Development and Course of Scars in the Comparison of Age-Related Macular Degeneration Treatments Trials (2018) · cites this paper as [19]
Some lesions may be difficult to categorise because delayed responders may not gain vision until well after 3 months and sometimes not until after 12 months.
“However, such lesions may be difficult to categorise as there are a group of 'delayed responders' who will not gain vision until well after 3 and sometimes not until after 12 months.22,24”
From Defining response to anti-VEGF therapies in neovascular AMD (2015) · cites this paper as [22]
The Primary and Secondary End Points section reports mean visual-acuity improvement by day 7 and outcomes at 12 and 24 months. It does not identify individual delayed responders or establish that some first gained vision after three or twelve months (searched for delayed responders and gains between 12 and 24 months). (LLM, conf=0.76)
Experimental — accuracy not yet measuredIn 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 [1]
Ranibizumab, when injected intravitreally monthly, was associated with a remarkable proportion of patients with an improvement in vision.
“was associated with a remarkable proportion of patients with an improvement in vision”
From Age-related macular degeneration (2008) · cites this paper as [164]
Ranibizumab is a fragment of a monoclonal antibody that binds to and inhibits all forms of VEGF-A.
“Ranibizumab is a fragment of a monoclonal antibody that binds to and inhibits all forms of VEGF-A.164,165”
From Age-related macular degeneration (2008) · cites this paper as [164]
Ranibizumab, when injected intravitreally monthly, prevented vision loss in patients with neovascular age-related macular degeneration.
“This drug, when injected intravitreally on a monthly basis, prevented vision loss”
From Age-related macular degeneration (2008) · cites this paper as [164]
The benefits of ranibizumab on visual acuity persisted through 24 months of follow-up.
“These benefits persisted through 24 months of follow-up.”
From Age-related macular degeneration (2008) · cites this paper as [164]
Mean visual acuity score increased by seven letters in the ranibizumab-treated group compared with a mean decrease of 10 letters in the placebo group (p<0.001).
“Mean differences in visual acuity score in the treated and control groups were also impressive, with a mean increase of seven letters in the treated group compared with a mean decrease of 10 letters in the placebo group (p<0·001).”
From Age-related macular degeneration (2008) · cites this paper as [164]
At 12 months, 95% of patients given ranibizumab 0.5 mg lost fewer than 15 letters compared with 62% of the placebo group (p<0.001).
“At 12 months, 95% of patients given ranibizumab 0·5 mg lost fewer than 15 letters (three lines of vision) compared with 62% of the placebo group (p<0·001).”
From Age-related macular degeneration (2008) · cites this paper as [164]
Ranibizumab was the first treatment for age-related macular degeneration associated with a remarkable proportion of patients with an improvement in vision.
“for the first time with any treatment for age-related macular degeneration, was associated with a remarkable proportion of patients with an improvement in vision”
From Age-related macular degeneration (2008) · cites this paper as [164]
At 12 months, 34% of patients given ranibizumab 0.5 mg improved by 15 or more letters compared with 5% of the placebo group (p<0.001).
“Additionally, 34% of this group improved by 15 or more letters of vision compared with the 5% in the placebo group (p<0·001).”
From Age-related macular degeneration (2008) · cites this paper as [164]
Adverse effects of ranibizumab included endophthalmitis (1%) and serious uveitis (1%).
“The adverse effects included endophthalmitis (1%) and serious uveitis (1%).”
From Age-related macular degeneration (2008) · cites this paper as [164]
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- Authors
- Rosenfeld, P. J., Brown, D. M., Heier, J. S., Boyer, D. S., Kaiser, P. K., Chung, C. Y., & Kim, R. Y.
- Affiliations
- University of Miami (US)
- Houston Methodist (US)
- Ophthalmic Consultants of Boston (US)
- Retina Vitreous Associates Medical Group (US)
- Cleveland Clinic (US)
- Genentech (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2006-10-05
- Volume
- 355
- Issue
- 14
- Pages
- 1419-1431
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2124415048
- Cited by
- 5,886
- References
- 25
- Citations by year
- 2026: 179 · 2025: 231 · 2024: 207 · 2023: 198 · 2022: 242 · 2021: 324 · 2020: 311 · 2019: 259 · 2018: 286 · 2017: 325 · 2016: 313 · 2015: 356 · 2014: 358 · 2013: 371 · 2012: 371
- FWCI
- 240.91
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- University of Pennsylvania
- Pennsylvania State University
- University of South Florida
- Towson University
- Genentech
- Topics
- Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Retinal and Macular Surgery
- Health Sciences › Medicine › Ophthalmology › Ocular Diseases and Behçet’s Syndrome
- Keywords
- ranibizumab, neovascular age-related macular degeneration, choroidal neovascularization, intravitreal injection, anti-VEGF therapy, VEGF-A, visual acuity, blindness prevention, endophthalmitis, uveitis, adverse events, long-term follow-up, dose comparison, occult choroidal neovascularization, anti-angiogenic therapy, VEGF inhibitors
- MeSH terms
- Ranibizumab, Aged, Aged, 80 and over, Antibodies, Monoclonal, Double-Blind Method, Female, Humans, Injections, Macular Degeneration, Male, Middle Aged, Optic Disk, Visual Acuity, Choroidal Neovascularization, Angiogenesis Inhibitors, Antibodies, Monoclonal, Humanized
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