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Anti-VEGF improves vision up to 1 year in patients with macular edema due to CRVO
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Monthly intravitreal aflibercept injections significantly improved visual acuity in patients with macular edema secondary to central retinal vein occlusion at 24 weeks, according to a study. As-needed dosing then extended the improvement through 52 weeks.
The COPERNICUS study, a phase 3 randomized multicenter trial, included 189 patients with macular edema secondary to CRVO. For 24 weeks, 115 patients underwent six monthly intravitreal injections of 2-mg Eylea (aflibercept, Regeneron), and 74 patients underwent sham treatment under the same protocol.
From 24 weeks to 52 weeks, patients in both groups underwent monthly evaluation and received aflibercept injections as needed or sham injections if no treatment was needed.
Study results showed that at 24 weeks, 56.1% of patients in the aflibercept group and 12.3% of patients in the sham treatment group gained at least 15 letters. At 52 weeks, 55.3% of patients in the aflibercept group and 30.1% of patients in the sham treatment group gained 15 or more letters. Both differences were statistically significant (P < .001).
The most frequent adverse events in both groups were conjunctival hemorrhage, eye pain, diminished visual acuity and elevated IOP, the authors said.
Perspective
Back to TopGlenn J. Jaffe, MD
This treatment was very effective to improve visual acuity and to decrease central retinal vein occlusion-associated macular edema during 1-year follow-up. The gains that were seen at 6 months held after 1 year.
The new thing that this study adds, compared to the original report, are the results of the second 6 months of treatment. The treatment group was given monthly treatment for 6 months and after the second 6 months, they were then given aflibercept as needed. The other group, the sham group, which had not been treated for the first 6 months, was then treated according to that same regimen, the as-needed regimen. The bottom line was that the visual gains that were made during the first 6 months in the treated group were maintained nearly identically at 1 year. Between 6 months and 1 year, there really was not much decline.
One question would be, “Well, why not just continue to treat patients every month for a year, instead of switching to an as-needed strategy?” The switch to an as-needed strategy during the second 6 months affords a more real-world type of therapy because physicians are not likely to give treatment every month indefinitely, just as they have proven with anti-VEGF therapy for macular degeneration. Furthermore, by treating the sham group with as-needed therapy during the second 6 months, it gave the previously untreated patients a chance to improve with anti-VEGF injections.
Another question would be, “How many injections can you save by not injecting every month, by doing that PRN treatment?” Approximately three treatments were given, on average, in the second 6 months. Had they been treated every month, they would have received six injections during this time period. So, you essentially cut in half the number of treatments they would need and still maintain the visual acuity results out to a year. Again, it remains to be seen whether that will continue for the subsequent year but at least it is quite encouraging.
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