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Avastin, Eylea, Lucentis sustain improved visual acuity gains in DME in DRCR.net protocol
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Intravitreal Avastin, Eylea and Lucentis similarly sustained visual acuity gains in patients with visually significant center-involved diabetic macular edema, according to a study.
However, in eyes with worse baseline visual acuity, Eylea (aflibercept, Regeneron) improved vision significantly more than Avastin (bevacizumab, Genentech) and Lucentis (ranibizumab, Genentech).
The multicenter, randomized clinical trial, undertaken by the Diabetic Retinopathy Clinical Research Network (DRCR.net) and sponsored by the National Institutes of Health, was designed to compare the safety and efficacy of aflibercept, bevacizumab and ranibizumab in the treatment of DME.
The study included 660 patients who were randomized to receive aflibercept 2 mg (224 patients), bevacizumab 1.25 mg (218 patients) or ranibizumab 0.3 mg (218 patients).
Injections were given as frequently as every 4 weeks. The median number of intravitreal injections was nine in the aflibercept group and 10 in both the bevacizumab group and the ranibizumab group.
The primary outcome measure was mean change in visual acuity from baseline to 1 year.
Overall, mean visual acuity letter scores improved by 13.3 in the aflibercept group, 9.7 in the bevacizumab group and 11.2 in the ranibizumab group from baseline to 1 year.
“On average, greater improvement was seen with aflibercept than with the other agents, although the magnitude of the greater effect of aflibercept lacked clinical applicability because it was dependent on initial visual acuity,” the study authors said.
In eyes with baseline Snellen-equivalent visual acuity of 20/32 to 20/40, mean improvement in visual acuity letter scores was 8 in the aflibercept group, 7.5 in the bevacizumab group and 8.3 in the ranibizumab group.
In eyes with baseline visual acuity of 20/50 or worse, mean improvement in visual acuity letter scores was 18.9 in the aflibercept group, 11.8 in the bevacizumab group and 14.2 in the ranibizumab group. In this group, there was a statistically significant difference between aflibercept and bevacizumab (P < .001) and aflibercept and ranibizumab (P < .003), but not between bevacizumab and ranibizumab.
All three groups had similar rates of serious adverse events, hospitalization, death and major cardiovascular events. – by Matt Hasson
Disclosure: Wells reports he receives grant support from Allergan, Genentech, KalVista and Regeneron outside the submitted work. Please see the full study for a list of all other authors’ relevant financial disclosures.
Perspective
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Charles C. Wykoff, MD, PhD
Extensive data have confirmed the efficacy of anti-VEGF therapy in the management of exudative retinal diseases including DME, but few trials have directly compared the efficacy and safety of these agents with each other. DRCR-T stands alone in being the only substantial, prospective trial to date to directly compare the three agents head-to-head.
Top line results indicate that treatment with either aflibercept, bevacizumab or ranibizumab resulted in clinically meaningful average visual acuity (VA) gains. Mean VA gains at 1 year were greatest with aflibercept (+13.3) compared with bevacizumab (+9.7) or ranibizumab (+11.2). In a pre-specified subgroup analysis, this medication effect on VA gains was strongly influenced by baseline VA.
Specifically, among patients with initial mild visual impairment (20/32-20/40), representing 51% of the study population, mean VA improvements were similar between arms: aflibercept +8.0, bevacizumab +7.5 and ranibizumab +8.3. In comparison, among patients with initial VA of 20/50 or worse, representing 49% of the study population, mean VA improvement was significantly increased with aflibercept +18.9 compared with bevacizumab +11.8 or ranibizumab +14.2.
Anatomically, aflibercept and ranibizumab were both significantly better retinal-drying agents than bevacizumab. Among both the subgroups of patients with mild visual impairment and patients with 20/50 or worse VA, bevacizumab was significantly worse at drying the retina.
Aflibercept treatment led to fewer median injections administered: nine compared to 10 for both bevacizumab and ranibizumab, and aflibercept treatment was associated with fewer macular laser treatments (37%) compared to bevacizumab (56%) and ranibizumab (46%).
A key limitation of the trial is that the bevacizumab used was provided in individual glass vials, as was performed in CATT. The process of compounding and storing bevacizumab in certain syringes may result in variability in the integrity and biological activity of the medication. We do not know if compounded bevacizumab stored and delivered in plastic syringes, the norm for retina practices around the world, is functionally distinct from the bevacizumab used in DRCR-T.
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