The treatment, traditionally used for cancer, not only improved BVCA measurements but also resulted in the number of injections patients needed.
Mohammad Hossein Jabbarpoor Bonyadi, MD
Ziv-aflibercept (Zaltrap, Sanofi Genzyme), while normally used for the treatment of colorectal cancer, has demonstrated a stronger effect than bevacizumab (Avastin, Genentech) in improving best-corrected visual acuity (BCVA) in patients with diabetic macular edema (DME),
Additionally, the study findings, presented at the American Society of Retina Specialists (ASRS) annual meeting in Vancouver, British Columbia, revealed that there was a stronger effect in patients with an initial worse VA (≤20/50), as these patients showed the most improvement.
The study authors, led by Mohammad Hossein Jabbarpoor Bonyadi, MD, of the Shahid Beheshti University of Medical Sciences, in Tehran, Iran, noted that the improved binding properties of ziv-aflibercept in comparison to bevacizumab’s can not only reduce the number of injections, and in turn help alleviate the oft-discussed burden of multiple injection treatments on patients.
“Ziv-aflibercept seems to be a potential and cost-effective substitute for aflibercept in the same way as bevacizumab is a cost-effective substitute for ranibizumab,” Bonyadi and colleagues wrote. “Since vision improvement is the surrogate endpoint and using lower doses is presumably safer, we still suggest [a] 1.25-mg dose for treatment of DME.”
The trial consisted of 135 eyes from 93 patients, with the final analysis including 123 eyes from 83 patients. Patients were randomized 1:1:1 to either 2.5-mg (0.1 ml) intravitreal ziv-aflibercept (n = 42), 1.25-mg (0.05 ml) intravitreal ziv-aflibercept (n = 42), or 1.25-mg (0.05 ml) intravitreal bevacizumab (n = 39). In the instance that a single patient was bilaterally treated (n =40), each eye was randomized independently, with 17 patients getting the same injection in both eyes.
Eyes in the ziv-aflibercept group were treated with injections every 8 weeks, and those treated by bevacizumab were treated every 4 weeks. The authors noted that injections continued unless BCVA was measured at ≥20/30 and/or central macular thickness (CMT) reduced to ≤300 microns.
The findings revealed a significant improvement in logMAR BCVA of -0.38 ±0.34 for the 1.25-mg ziv-aflibercept group, equivalent to an improvement in Early Treatment Diabetic Retinopathy Letters Study (ETDRS) score of 18 letters, a 0.20 logMAR greater improvement than bevacizumab (P = .007). Likewise, the 2.5-mg ziv-aflibercept group saw an improvement of -0.33 ±.026 logMAR (ETDRS, 16 letters), a 0.16 logMAR greater score compared to -0.26 ±035 logMAR (ETDRS, 14 letters) with bevacizumab (P = .029).
In subgroup analysis, no difference in BCVA outcomes at 1 year was observed among eyes with baseline BCVA >20/50 in the ziv-aflibercept groups compared to the bevacizumab group. “In the eyes with baseline BCVA ≤20/50, nonetheless, the improvement was significantly better at 1 year in both ziv-aflibercept groups compared to the [bevacizumab] group (P = .002 for 2.5 mg and P = .001 for 1.25 mg),” Bonyadi and colleagues explained.
Overall, both doses of ziv-aflibercept proved to be statistically significantly favorable in comparison with bevacizumab (P = .006). A >0.2 logMAR improvement of BCVA was detected in 69.7% of the eyes treated with 2.5-mg ziv-aflibercept, 70% of those given 1.25-mg ziv-aflibercept, and 53.3% of those eyes administered bevacizumab.
“The mean number of injections for the 2.5-mg and 1.25-mg ziv-aflibercept groups were 6.71 and 6.67, respectively, in contrast with 11.56 injections for the bevacizumab group,” Bonyadi and colleagues noted.
CMT measurements revealed significant decreases compared to baseline values in all treatment arms at the 1-year mark. For the 1.25-mg ziv-aflibercept group, there was a -131 ±141µm decrease, for the 2.5-mg ziv-aflibercept group there was a -125 ±125µm decrease, and for the bevacizumab group there was a -113 ±139 µm decrease.
The study, “One-year results of RCT comparing 2 doses of intravitreal ziv-aflibercept vs bevacizumab for treatment of DME,” was presented as a poster at ASRS’s 36th annual meeting.
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