First Author: P.Dugel USA
Co Author(s): L. Feiner K. Drenser D. Miller C. Mein M. Benz M. Fineman
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The Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) study demonstrated the long-term efficacy and safety profile of ocriplasmin for the treatment of symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT), including full-thickness macular hole (FTMH). Here, for the first time, we present the results of measurements of visual function in the study including Amsler Grid, Roth 28 Hue Test, and Contrast Sensitivity in patients receiving ocriplasmin for VMT.
The OASIS study (NCT01429441) was conducted at 25 sites in the USA.
OASIS was a phase 3b, randomized, sham-controlled, double-masked, multicentre clinical study. Patients (≥18 years of age) were randomized (2:1 ratio) to receive a single intravitreal injection of ocriplasmin 0.125 mg (N=146) or sham injection (N=74). Randomization was stratified based on the presence or absence of FTMH at baseline. The study comprised 12 visits over a 24-month follow-up period: pre-injection visit (baseline), injection visit, and 10 post-injection visits. Inclusion criteria included the presence of VMA and best-corrected visual acuity (BCVA) of 20/32 or worse in the study eye. Exclusion criteria included FTMH >400 µm diameter, presence of epiretinal membrane, and aphakia in the study eye. Metamorphopsia (Amsler Grid), colour vision (Roth 28 Hue Test; not needed if the patient was aged >80 years or had a diagnosis of dyschromatopsia), and contrast sensitivity score (Pelli-Robson, CSS) were measured at every study visit, and were summarized as shifts from baseline by visit. Data are presented as percentages (calculated using n/N) with associated 95% confidence intervals (CI).
Overall, 67.3% (147/218) of patients were female, 89.5% (195/218) Caucasian and the mean (±SD) age was 69.1 (10.3) years. Demographic characteristics were similar between groups. At baseline, 25.4%, 37.0%, and 77.4% of patients with ocriplasmin and 20.6%, 44.6%, and 78.4% with sham had abnormal colour vision, CSS (<1.5 log unit), and Amsler Grid evaluation, respectively. By end of study (EOS) 5.9% (CI 2.4-11.7), 14.5% (CI 9.1-21.5), 36.6% (28.7-44.9) in the ocriplasmin and 3.6% (CI 0.4-12.3), 15.1% (7.8-25.4), 26.4% (CI 16.7-38.1) in the sham group improved from abnormal to normal for colour vision, CSS, and Amsler grid, respectively. At Day 7: 10.9% (CI 6.1–17.7) of ocriplasmin and 0% (CI 0.0–5.9) of sham patients with a normal colour vision test at baseline shifted to abnormal; all except 2 patients recovered by EOS. A shift from normal CSS at baseline to abnormal occurred in 15.3% (CI 9.8–22.2) of patients with ocriplasmin vs 1.4% (CI 0.0–7.5) with sham; all except 2 recovered to normal by EOS. Very few Amsler Grid evaluation shifted to abnormal in both ocriplasmin and sham patients [2.1% (CI 0.4–6.0) vs 1.4% (CI 0.0–7.5), respectively].
The data presented here demonstrate for the first time that a single intravitreal injection of ocriplasmin improved the Amsler Grid evaluation and Roth 28 Hue Test measures compared to baseline by EOS. Although a small number of patients with normal Amsler Grid and Roth 28 evaluations at baseline shifted to abnormal at Day 7, all of them recovered during the study, with only a few exceptions. No apparent differences between treatment groups were observed by EOS in proportions with shifts from baseline in contrast sensitivity measures. These new data suggest that treatment with ocriplasmin may improve the structure and function of photoreceptors in the retina likely due to release of traction. Study supported by ThromboGenics