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Visual results comparable for monthly vs. as-needed anti-VEGF for retinal vein occlusion
Analysis of the SHORE study finds greater OCT macular thickness in the as-needed group but no clinical ramifications.
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After attaining macular edema stability with seven monthly injections of ranibizumab, patients with retinal vein occlusion achieved equivalent visual outcomes with either continued monthly injections or as-needed dosing through month 15, according to an analysis of data from the SHORE study.
“At the 2013 American Academy of Ophthalmology meeting, we presented the top-line visual and anatomic outcomes of the SHORE study,” lead investigator Charles C. Wykoff, MD, PhD, told Ocular Surgery News. “That study was designed to advance our understanding of retinal vein occlusion management based on two previous phase 3 clinical trials: the BRAVO and CRUISE studies. Those trials led to FDA approval of Lucentis 0.5 mg (ranibizumab, Genentech) for the treatment of macular edema due to branch and central retinal vein occlusion. However, neither of these trials directly compared monthly vs. as-needed re-treatment.”
Randomization
Of the 202 patients with branch or central retinal vein occlusion with macular edema enrolled in the SHORE study, 171 patients met stability criteria after a minimum of seven ranibizumab injections; 85 were randomized to monthly dosing and 86 to as-needed dosing. As-needed patients were seen every month.
“In the as-needed arm, when there was evidence of activity of disease on spectral-domain optical coherence tomography or vision, patients were re-treated,” Wykoff said. The mean number of follow-up injections in the as-needed group was 3.7 (range: 0 to 7), compared with a maximum of seven injections over the 8-month follow-up period in the monthly treatment arm.
Despite significantly fewer subsequent injections in the as-needed group, changing from monthly to as-needed dosing resulted in SD-OCT macular thickness increasing by about 40 µm, or 14%. “But this did not seem to have an effect on visual outcomes,” Wykoff said.
At 15 months, the mean change from baseline for best corrected visual acuity was a gain of 21 letters in the as-needed arm and 18.7 letters in the monthly arm.
Analysis
The analysis, which was presented in a poster at the AAO meeting, found that both branch and central retinal vein occlusion seemed to do equally well with either dosing schedule.
There were also no differences in ocular or systemic safety events, including any dose-exposure trends.
There was one death in the nonrandomized group and one cerebrovascular accident in the monthly treatment group. “We do not believe that either of these occurrences was caused by the injections,” Wykoff said.
For patients who failed to achieve disease stability by 7 months, “the question still remains as to why their disease continued to fluctuate,” Wykoff said. “Some clinicians would consider using ultra-widefield fluorescein angiography, for example, to look for areas of peripheral retinal ischemia. If there is significant peripheral retinal ischemia, some people would think about treating those areas in an attempt to decrease the VEGF drive within the eye.”
Wykoff and colleagues are in the process of scheduling a follow-up visit for all patients to evaluate their widefield fluorescein angiogram as a predictor for treatment and outcomes.
“We are also doing subanalysis of the data to better understand the patients that never met stability criteria,” he said.
In Wykoff’s own clinical practice, he often uses a treat-and-extend dosing regimen.
“This approach was not evaluated by the SHORE study and needs to be evaluated by other prospective trials in the future,” he said. “I think it is a nice hybrid between monthly and PRN injections. There are fewer treatments over time and less treatment burden from the patient perspective because of fewer office visits.” – by Bob Kronemyer