ADA's Position Statement Advises on Role of Anti-VEGF Agents in DME

The American Diabetes Association recently issued a position statement on diabetic retinopathy featuring recommendations on the treatment of central-involved diabetic macular edema, or CIDME, as well as proliferative diabetic retinopathy.

In the new position statement, Sharon D. Solomon, MD, of the Wilmer Eye Institute at Johns Hopkins Medicine (pictured) along with distinguished colleagues nationwide recommend prompt referral of patients with any macular edema or with severe nonproliferative or proliferative diabetic retinopathy to an ophthalmologist experienced in the treatment of these conditions.

In addition, they advise that intravitreous injections of anti-vascular endothelial growth factor (VEGF) agents are indicated for CIDME, which may threaten reading vision. They note that CIDME is defined as edema affecting the retinal central subfield measuring 1 mm in diameter.

According to the ADA experts, intravitreous therapy with anti-VEGF agents is the current standard of care for managing CIDME. To support this statement, they cite the results of many well-designed, randomized, phase 3 clinical trials showing the superior benefits of these injections compared with those of panretinal laser photocoagulation (PRP) alone or even of PRP combined with anti-VEGF injections.

Regarding type of anti-VEGF agent, they also cite data from the Diabetic Retinopathy Clinical Research Network (DRCRN), which found that for CIDME-affected eyes with a visual acuity of 20/40 or better, each agent improved visual acuity to a similar degree. However, they note that in CIDME-affected eyes with less visual acuity (20/50 or worse), aflibercept (Eylea/Regeneron) may be the most effective of the three available agents, aflibercept, bevacizumab (Avastin/Roche), and ranibizumab (Lucentis/Roche), at improving visual acuity.

The ADA experts also note that most patients need intravitreous injections of anti-VEGF agents nearly every month during the first year of treatment, after which fewer injections are needed to maintain CIDME in remission.

They add that the U.S. Food and Drug Administration has approved intravitreous dexamethasone and fluocinolone as well as anti-VEGF agents for the treatment of CIDME. However, they cite the inferior outcomes of intravitreous corticosteroids compared with those of intravitreous anti-VEGF injections in a large DRCRN trial as one reason corticosteroids are seldom used as first-line agents for CIDME. They add that the risk of cataract and glaucoma from the use of intravitreous corticosteroids provides another reason to reserve them for special cases.

In addition, according to the ADA experts, studies indicate that anti-VEGF injections are more cost-effective than PRP alone for DME. However, they add, more studies are needed to determine the cost-effectiveness of anti-VEGF agents when used as first-line treatment for proliferative diabetic retinopathy (PDR).

According to Solomon and colleagues, the proven value of anti-VEGF injections for CIDME led some to reason that these agents may be similarly useful for treating PDR. They note that in a key DRCRN trial, average two-year outcomes in visual acuity favored the group with PDR treated with ranibizumab over the comparator group treated with PRP. Moreover, they added, a significantly greater proportion of PRP-treated eyes than of anti-VEGF-treated eyes had a loss of peripheral visual field and needed vitrectomy.

They also note that DME developed in 28% of PRP-treated eyes during the study, compared with only 9% of ranibizumab-treated eyes. Moreover, both treatments yielded similar systemic safety outcomes, and in the ranibizumab group, endophthalmitis related to intravitreal injection occurred in only one eye (0.5%). Based on these findings, the ADA experts conclude that intravitreous anti-VEGF injections may be a useful alternative or addition to laser treatment of PDR for at least the first 2 years of treatment.

The report, “Diabetic retinopathy: a position statement by the American Diabetes Association,” appears in the March, 2017, issue of Diabetes Care.

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