April 24, 2014
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COPERNICUS study: Loss of visual, anatomic improvements seen after long-term anti-VEGF use

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Patients who received intravitreal aflibercept injections as needed for macular edema due to central retinal vein occlusion showed loss of visual and anatomic improvements at 100 weeks, according to the COPERNICUS study.

The study is an ongoing investigation in which patients were evaluated at week 24, week 52 and week 100.

The phase 3 randomized, double-masked trial included 188 patients with macular edema secondary to CRVO. Initially, 114 patients received a 2-mg dose of Eylea (aflibercept, Regeneron Pharmaceuticals) and 74 patients received sham injections every 4 weeks until week 24. From week 24 to week 52, patients received aflibercept injections as needed and were evaluated monthly. From week 52 to week 100, patients received aflibercept injections as needed and were evaluated quarterly.

At week 100, 49.1% of patients in the aflibercept group and 23.3% of patients in the sham group gained 15 or more letters. This compares with 56.1% and 12.3% at week 24 and 55.3% and 30.1% at week 52 respectively. All of the differences between the groups were statistically significant (P < .001).

Also at week 100, the mean reduction in central retinal thickness was 390 µm in the aflibercept group and 343.3 µm in the sham group. This compares with 457.2 µm and 144.8 µm at week 24 and 413 µm and 381.8 µm at week 52, respectively. Only the difference at week 24 was significant (P < .001).

“The COPERNICUS study results at week 100 corroborate the loss of visual and anatomic improvements after a quarterly or more frequent PRN dosing regimen with this protocol, suggesting that more frequent monitoring may be necessary, at least in some patients, for optimal outcomes,” the study authors said. “Thus, from a practical perspective, the suitability of PRN dosing with quarterly monitoring seems to be questionable.”

Disclosure: See the study for a full list of all authors’ relevant financial disclosures.