Ranibizumab, Aflibercept Both Effective for Diabetic Macular Edema in Real World

By Marilynn Larkin

December 11, 2019

NEW YORK (Reuters Health) - Both ranibizumab and aflibercept effectively treat diabetic macular edema (DME), one-year data from a registry study reveal.

Dr. Sanjeeb Bhandari of the University of Sydney and colleagues analyzed macular disease treatment outcomes in routine clinical practice to see "whether they are consistent with the promising results observed in the pivotal clinical trials and identify areas of improvement where they are not," he said.

"Previous clinical trials that compared aflibercept and ranibizumab for neovascular age-related macular degeneration reported that the visual outcomes were similar after two years of treatment, but with fewer aflibercept treatments," he noted.

"A clinical trial that compared the two for DME reported both drugs improved vision and reduced macular thickness after 12 months of treatment, but aflibercept was more effective in vision improvement in eyes that presented with visual acuity of 20/50 or worse," he said. "The difference was not observed after two years of treatment."

The present study analyzed data on treatment-naive eyes starting monthly intravitreal injections of either ranibizumab 0.5mg (166 eyes) or aflibercept 2mg (217 eyes) from 2013-2018.

As reported in Ophthalmology, eyes with severe non-proliferative diabetic retinopathy (DR) and proliferative DR were more likely to receive aflibercept. Eyes receiving ranibizumab tended to have better mean vision (67.8 letters vs. 64.7) and somewhat lower mean central subfield thickness (407 micrometers vs. 433). However, the differences were not significantly different.

In addition, at the start, patients on ranibizumab were older (mean age, 65.4 years vs. 62.7), with a longer duration of diabetes (mean, 16 years vs. 15).

After 12 months of treatment, in eyes with an initial visual acuity of at least 20/40 (at least 69 letters), the adjusted mean difference in visual acuity change and central subfield thickness reduction were +1 letter (1.4 for aflibercept versus 0.4 for ranibizumab) and -30 microns (-85 versus -55). Corresponding differences for eyes with a visual acuity of 20/50 or less (68 letters or less) were +3 letters (10.6 versus 7.6) and -46 microns (-148 versus -102).

Eyes in the aflibercept group received more injections over 12 months - i.e., a median of 8 compared with 6 for the ranibizumab group - but the difference was not significant.

Treatment switches were low, but more frequent from ranibizumab to aflibercept than vice versa.

Further, significantly more eyes in the aflibercept group were lost to follow-up within 12 months (21% versus 9%).

Summing up, the authors state, "Both drugs were beneficial for DME. Aflibercept-treated eyes, which had borderline worse vision and thicker maculae at baseline, had larger reductions in CST after 12 months of treatment. Larger gains in VA (were) observed with aflibercept treatment when the initial VA was less than 20/50."

Dr. Bhandari said additional observational studies are needed to determine whether the findings hold over the long term.

Dr. Shriji Patel of the Vanderbilt Eye Institute in Nashville, Tennessee, commented by email, "While we know both of these medications work, this is the first comparison of the two in daily clinical practice. The anatomic and vision changes are below what we typically see in rigorously conducted randomized clinical trials."

"The authors should be commended for attempting to better understand how these medications benefit our patients in daily practice," he told Reuters Health. "However, these types of 'real-world' studies are inherently limited. A heterogenous pool of patients and providers makes interpretation of the results difficult. All treatment decisions are based on practitioner discretion rather than predefined guidelines or reading center assessments."

"The ranibizumab and aflibercept groups were not evenly matched, with different baseline visions and optical coherence tomography central subfield thicknesses," he added. "Understanding how these medications work in daily practice is important, but more importantly, we must focus on why we are not achieving the results we see in well-conducted randomized controlled trials."

The Fight Retinal Blindness! Project is supported by a grant from the Macular Disease Foundation Australia and unrestricted educational grants from Bayer and Novartis.

SOURCE: http://bit.ly/2rl5I7x Ophthalmology, online November 26, 2019.