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  • 2-Year Results From the OASIS Randomized Trial

    By Marianne Doran and edited by Susan M. MacDonald, MD
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    Journal Highlights

    Ophthalmology, October 2016

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    Dugel et al.     reported the 2-year results from the Ocriplasmin for Treatment of Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) trial. This trial evaluated the long-term efficacy and safety of intravitreal ocri­plasmin for the treatment of symptom­atic vitreomacular adhesion (VMA), including full-thickness macular hole (FTMH). They found that ocriplas­min yielded a higher success rate of resolution of VMA and macular hole compared with sham.

    This phase 3b randomized con­trolled double-masked clinical trial included 220 participants (146 as­signed to ocriplasmin and 74 to sham), who were assessed at 12 visits over 24 months. Among the inclusion criteria were the presence of symptomatic VMA and best-cor­rected visual acuity (BCVA) of 20/32 or worse in the study eye. Patients with FTMH >400 μm, presence of epiret­inal membrane, or aphakia in the study eye were excluded.

    The primary efficacy end point was the proportion of subjects with VMA resolution at day 28. Secondary efficacy end points were assessed at month 24 and included the proportion of subjects with BCVA improvement from baseline, nonsurgical FTMH clo­sure, vitrectomy, and Visual Function Questionnaire 25 (VFQ-25) outcomes.

    The researchers found that the rate of VMA resolution at day 28 was significantly higher in the ocriplasmin group (41.7%) compared with the sham group (6.2%) and that the treat­ment effect was maintained until the end of the study.

    BCVA improvement of ≥2 lines from baseline was seen in 50.5% of the ocriplasmin group versus 39.1% of subjects in the sham group. The nonsurgical FTMH closure rate was 30.0% for the ocriplasmin group com­pared with 15.4% for the sham group. All other secondary end points also favored ocriplasmin over sham treat­ment. Regarding safety, most adverse events were mild to moderate, had a short onset time, and were transient, with no new safety signals identified.

    The authors stated that the OASIS trial provides the largest sample size to date for the analysis of the long-term effects of ocriplasmin assessed in a prospective, standardized manner over a 2-year period. They concluded that this trial demonstrates the long-term efficacy and safety of ocriplasmin and shows a higher rate of pharmacological resolution of symptomatic VMA com­pared with previous phase 3 trials.

    The original article can be found here.