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Michaella Goldstein, Jean-Francois Korobelnik, Christiane Norenberg, Oliver Zeitz, ; Subanalysis of Visual Acuity Outcomes in the Second Year of VIEW Studies. Invest. Ophthalmol. Vis. Sci. 2013;54(15):3171.
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Assess efficacy of retreatment with intravitreal aflibercept injection (IAI) or ranibizumab in an integrated analysis of the VIEW studies.
Patients with neovascular age-related macular degeneration (n=2412) were randomized to monthly ranibizumab 0.5 mg (Rq4), monthly IAI 2 mg (2q4), monthly IAI 0.5 mg (0.5q4), or IAI 2 mg every-other-month (2q8) following 3 initial monthly doses. Primary endpoint was evaluated at Week 52. Between Weeks 52-96, injections were given at 12-week intervals, but could be given up to every 4 weeks for any of the pre-specified criteria: increased central retinal thickness (CRT) ≥100 μm compared to the lowest previous value; loss of ≥5 ETDRS letters from best previous score with recurrent fluid; new onset classic neovascularization or hemorrhage; new or persistent fluid by OCT or leak on FA. Subgroup analyses were performed post-hoc.
From Week 52-96, all groups received on average 4.1-4.7 injections and slight, overall trend of visual acuity (VA) loss was observed at Week 96 vs 52. Subgroup analysis indicated that slight loss was mainly driven by ~20% of patients in all groups that lost ≥5 letters between Week 52-96 despite an as-needed retreatment scheme with rigorous retreatment criteria based on morphological parameters. This group was stable from baseline until Week 52 but lost on average >11 letters with either drug when switched to reactive treatment; CRT did not change concomitantly. The subgroup received a similar number of injections as full study population. A separate subgroup analysis was conducted for patients who lost ≥5 letters between 2 consecutive treatments and subsequently received reactive treatment for Weeks 52-64. At 96 weeks, VA in these patients decreased from gains at Week 52 (+8.5-10.3 letters), to a VA of -2.5 to -3.8 letters below baseline, with no obvious changes in CRT. In this study, frequent ocular adverse events were conjunctival hemorrhage, eye pain, retinal hemorrhage, and reduced VA.
A subset of patients lost vision after the switch from proactive to reactive treatment with either IAI or ranibizumab. If vision is lost and reactively treated, it may not recover. In all subgroups, CRT changes neither preceded nor paralleled changes in best-corrected VA. These results suggest reactive treatment based on current retreatment criteria may be inadequate to preserve vision and proactive treatment results in better visual outcomes.
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