Bevacizumab Effective for Macular Edema Due to Central Retinal Vein Occlusion

By Will Boggs MD

May 15, 2017

NEW YORK (Reuters Health) - Bevacizumab is as effective as aflibercept for improving visual acuity in patients with macular edema due to central retinal vein occlusion, according to results from the SCORE2 trial.

“Although aflibercept has been demonstrated previously to be associated with superior visual acuity outcomes compared to bevacizumab in patients whose vision is at least moderately impaired due to diabetic macular edema, the SCORE2 Investigative Group found that, among patients with vision impairment due to macular edema associated with central retinal or hemiretinal vein occlusion, bevacizumab was non-inferior to aflibercept at 6 months with respect to visual acuity after 6 months of treatment, based on a non-inferiority margin of 5 letters of vision,” said Dr. Ingrid U. Scott from Penn State College of Medicine in Hershey, Pennsylvania.

“Approximately one-third of the study population had been treated previously with anti-VEGF therapy and, interestingly, there was no difference in visual acuity outcomes at 6 months between eyes treated previously with anti-VEGF therapy and anti-VEGF therapy-naïve eyes,” she told Reuters Health by email.

Aflibercept is approved for treating macular edema due to central retinal vein occlusion, but bevacizumab is widely used off label because of its efficacy and safety in other retinal diseases and because its cost per dose (around $60) is much less than that of aflibercept ($1,850).

Dr. Scott and colleagues investigated whether bevacizumab was noninferior to aflibercept for treatment of macular edema due to central retinal or hemiretinal vein occlusion in their study of 366 patients from 66 U.S. centers.

Visual acuity letter score (VALS) improved from 50.3 at baseline to 64.1 at month 1 in the aflibercept group and from 50.4 to 62.3 in the bevacizumab group, the researchers report in JAMA, online May 9.

By six months, VALS had further improved to 69.3 in both groups, demonstrating that bevacizumab is noninferior to aflibercept.

Similar percentage of the eyes in the aflibercept group (65.1%) and bevacizumab group (61.3%) had a VALS gain of at least 15 at six months.

Patients in both groups experienced significant central subfield thickness decreases from baseline through month six, although the odds of complete resolution of macular edema was significantly lower in the bevacizumab group (28.5% of eyes) than in the aflibercept group (54.4% of eyes).

“Although the lower proportion of eyes with resolution of fluid among eyes treated with bevacizumab did not translate into poorer visual acuity outcomes at 6 months, continued follow-up of study participants will permit evaluation of the cumulative effect of the presence of fluid on vision and on the number of injections administered between months 6 and 12 of the trial (after month 6 of the trial, monthly injections are no longer mandated by the trial protocol in all study participants),” Dr. Scott said.

“Patients for whom a clinician may believe that complete resolution of the macular edema and lower retinal thickness is particularly important (such as patients who may have difficulty returning to the retina specialist’s office or who have difficulty tolerating intravitreal injections) may be specifically considered for aflibercept therapy,” she added.

Ocular adverse events were uncommon but more frequent in the bevacizumab group (6/182 eyes) than in the aflibercept group (2/180 eyes).

“The SCORE2 Investigative Group is continuing to follow patients, which will provide important additional information, such as whether the presence of residual fluid at 6 months will impact longer-term visual acuity outcomes and/or the number of treatments administered,” Dr. Scott said.

Dr. Neil M. Bressler from Johns Hopkins University School of Medicine's Wilmer Eye Institute, in Baltimore, Maryland, who wrote a linked editorial, told Reuters Health by email, "All 3 commonly available anti-VEGF agents are effective and safe for macular edema due to a central retinal or hemiretinal vein occlusion for at least 6 months, but the long-term need for anti-VEGF therapy in many of these eyes necessitates long-term data to guide choice of agent as well as retreatment and follow-up visit regimens.”

“For patients already being treated with one of these agents who are doing well, this study does not suggest a need to switch anti-VEGF agents,” he said. “For patients not doing well despite anti-VEGF treatment, SCORE2 does not provide data as to whether switching agents will result in better outcomes than continuing use of the same anti-VEGF agent.”

“For patients not previously treated, one needs to consider the SCORE2 results, accessibility of these agents (due to cost or other limitations), and recognition that data beyond 6 months of follow-up are needed when monthly dosing no longer may be performed in order to determine which agent might be the best recommendation for a particular patient,” Dr. Bressler concluded.

The authors presented these findings on May 9 at the Association for Research in Vision and Ophthalmology (ARVO) in Baltimore.

Four of the 10 authors report various relationships with Regeneron, Allergan and/or Genentech.

SOURCE: http://bit.ly/2q9h4s6 and http://bit.ly/2r9jYuQ

JAMA 2017.

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