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ASSESSMENT OF ANATOMICAL AND FUNCTIONAL OUTCOMES WITH OCRIPLASMIN TREATMENT IN PATIENTS WITH VITREOMACULAR TRACTION WITH OR WITHOUT MACULAR HOLES: Results of OVIID-1 Trial

Tadayoni, Ramin, MD, PhD*; Holz, Frank G., MD; Zech, Christophe, MD, PhD; Liu, Xin, MD§; Spera, Claudio, MD§; Stalmans, Peter, MD, PhD

doi: 10.1097/IAE.0000000000002332
Original Study: PDF Only

Purpose: To evaluate the anatomical and functional outcomes with ocriplasmin in patients with vitreomacular traction (VMT) with or without macular hole (MH).

Methods: 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.

Results: 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.

Conclusion: Ocriplasmin is effective for resolution of VMT without or with MH (≤400 μm); treatment outcomes can be optimized with patient selection.

This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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: ramin.tadayoni@aphp.fr

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.

© 2018 by Ophthalmic Communications Society, Inc.