To evaluate the anatomical and functional outcomes with ocriplasmin in patients with vitreomacular traction (VMT) with or without macular hole (MH).
In a Phase 4, multicenter, single-arm, open-label study, eligible patients (VMT with focal adhesion, without epiretinal membrane, and with MH ≤400 µm [if present]) received a single intravitreal injection of ocriplasmin. Nonsurgical resolution of VMT (Day 28 [primary endpoint]), best-corrected visual acuity, MH closure, vitrectomy rate, and safety were assessed through Day 180.
Overall, 466 patients were included in the full analysis set, of whom 47.4% had VMT resolution by Day 28; resolution rates in patients with VMT without MH, VMT with MH ≤250 µm, and VMT with MH >250 to ≤400 µm were 43.4%, 68.6%, and 62.7%, respectively. Macular hole closure was higher in eyes with VMT and MH ≤250 µm (57.1%) than in eyes with VMT and MH >250 to ≤400 µm (27.5%) at Day 28. Overall, 30.8% of patients with VMT resolution gained ≥10 letters in best-corrected visual acuity at Day 180. Adverse events were consistent with the known safety profile of ocriplasmin.
Ocriplasmin is effective for resolution of VMT without or with MH (≤400 μm); treatment outcomes can be optimized with patient selection.
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Enzymatic vitreolysis with ocriplasmin is more effective in patients with focal vitreomacular adhesion without epiretinal membrane and macular hole ≤400 µm (if present) at baseline. This study shows that the treatment outcomes are related to patient selection.
*Department of Ophthalmology, Hôpital Lariboisière (AP-HP), Université Paris 7 (Sorbonne Paris Cité), Paris, France;
†Department of Ophthalmology, University of Bonn, Bonn, Germany;
‡Centre Ophtalmologique Kléber, Lyon, France;
§Novartis Pharma AG, Basel, Switzerland; and
¶Department of Ophthalmology, University Hospitals Leuven (UZ Leuven), Leuven, Belgium.
Reprint requests: Ramin Tadayoni, MD, PhD, Department of Ophthalmology, Hôpital Lariboisière (AP-HP), Université Paris 7 (Sorbonne Paris Cité), 2, rue Ambroise Paré, 75010 Paris, France; e-mail: firstname.lastname@example.org
Supported by Alcon Research Ltd, Fort Worth, TX (a Novartis company).
Presented at: 15th European Society of Retina Specialists (EURETINA) Congress 2015, Nice, France, September 17–20, 2015; 16th European Society of Retina Specialists (EURETINA) Congress 2016, Copenhagen, Denmark, September 8–11, 2016; 47th Annual Scientific Congress of the Royal Australian and New Zealand College of Ophthalmologists (RANZCO), Wellington, New Zealand, October 31–November 4, 2015; 9th Asia Pacific Vitreo-Retina Society (APVRS) Congress, Sydney, Australia, July 31–August 2, 2015; Canadian Ophthalmological Society, Annual Meeting, Victoria, Canada, June 18–21, 2015; FLOREtina 2015, Florence, Italy, December 10–13, 2015; 121st French Society of Ophthalmology Congress, Paris, France, May 9–12, 2015; European Society of Ophthalmology Congress, Vienna, Austria, June 6–9, 2015; Oxford Ophthalmological Congress, Oxford, United Kingdom, July 5–8, 2015; 15th European School for Advanced Studies in Ophthalmology (ESASO) Retina Academy, Barcelona, Spain, October 22–24, 2015; 16th European School for Advanced Studies in Ophthalmology (ESASO) Retina Academy, Estoril, Portugal, June 23–25, 2016; 2015 Annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), Denver, Colorado, May 3–7, 2015; 2016 Annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), Seattle, Washington, May 1–5, 2016; and 113th Congress of German Ophthalmological Society (DOG), Berlin, Germany, October 1–4, 2015.
R. Tadayoni is a consultant for Alcon, Thrombogenics, Bausch + Lomb, Zeiss, Novartis, Bayer, Allergan, Alimera, Roche, Genentech, FCI, and Thea. F. G. Holz reports grants and personal fees from Alcon, Allergan, Novartis, Bayer Healthcare, Genentech/Roche, Heidelberg Engineering, and Acucela; grants from Zeiss, Optos, and Alimera; and personal fees from Boehringer Ingelheim. C. Zech is a consultant for Alcon and FCI. X. Liu and C. Spera are Novartis employees. P. Stalmans has received a research grant from Thrombogenics and is a consultant for Bausch + Lomb, DORC, Nano-Retina, Ophtec, ReNeuron, Vitreq, and Zeiss.