PMID- 30935657 OWN - NLM STAT- MEDLINE DCOM- 20191217 LR - 20191217 IS - 2468-6530 (Electronic) IS - 2468-6530 (Linking) VI - 3 IP - 1 DP - 2019 Jan TI - Ocriplasmin Treatment Leads to Symptomatic Vitreomacular Adhesion/Vitreomacular Traction Resolution in the Real-World Setting: The Phase IV ORBIT Study. PG - 32-41 LID - S2468-6530(17)30672-3 [pii] LID - 10.1016/j.oret.2018.07.011 [doi] AB - PURPOSE: To evaluate clinical outcomes and safety up to 12 months after ocriplasmin injection for the treatment of patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT) in a real-world setting. DESIGN: The Phase IV Ocriplasmin Research to Better Inform Treatment (ORBIT) trial (NCT02079883) was a Phase IV multicenter, prospective, observational study. PARTICIPANTS: Patients aged >/=18 years with symptomatic VMA/VMT treated with ocriplasmin. METHODS: Patients received a single 0.125 mg intravitreal injection of ocriplasmin. All assessments and treatment decisions were at the discretion of the treating physician. Spectral-domain OCT (SD-OCT) images were analyzed by an independent central reading center (CRC). All enrolled patients were included in demographic, baseline characteristics, and safety analyses. Patients with symptomatic VMA/VMT at baseline determined by CRC were included in baseline ocular characteristics and efficacy analyses. MAIN OUTCOME MEASURES: Clinical outcomes were measured up to 12 months and included resolution of symptomatic VMA, closure of full-thickness macular hole (FTMH), mean change from baseline in best-corrected visual acuity (BCVA), incidence of vitrectomy, and time to first vitrectomy. Safety outcomes included the incidence and timing of onset of adverse drug reactions (ADRs). RESULTS: Of the 539 patients enrolled, 480 were determined to have symptomatic VMA/VMT at baseline post-CRC assessment. After treatment with ocriplasmin, the rate of VMA/VMT resolution was 45.8% (95% confidence interval [CI], 41.3-50.4) at month 1 and 59% (95% CI, 54.4-63.4) at months 10 to 12. The rate of FTMH closure was 30.5% (95% CI, 22.4-39.7) at month 1 and 32.2% (95% CI, 23.9-41.4) at months 10 to 12. Mean (standard deviation) change from baseline in BCVA was 1.5 (11.19) letters at month 1 and 5.2 (13.60) letters at months 10 to 12. Vitrectomy was performed in 28.5% of patients, with a median time to vitrectomy of 63 days. Adverse drug reactions were reported by 30.6% of patients; 5.2% experienced a serious ADR. CONCLUSIONS: Results from the ORBIT study demonstrate that treatment with ocriplasmin is effective and well tolerated in patients with symptomatic VMA/VMT in a real-world setting. The percentage of patients with VMA/VMT resolution at month 1 was higher than previously reported in well-controlled clinical trials. No new safety signals were identified. CI - Copyright (c) 2018 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. FAU - Khanani, Arshad M AU - Khanani AM AD - Sierra Eye Associates, Reno, Nevada. Electronic address: arshad.khanani@gmail.com. FAU - Duker, Jay S AU - Duker JS AD - New England Eye Center, Boston, Massachusetts; Tufts University School of Medicine, Boston, Massachusetts. FAU - Heier, Jeffrey S AU - Heier JS AD - Ophthalmic Consultants of Boston, Boston, Massachusetts. FAU - Kaiser, Peter K AU - Kaiser PK AD - Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio. FAU - Joondeph, Brian C AU - Joondeph BC AD - Colorado Retina Associates, PC, Denver, Colorado. FAU - Kozma, Petra AU - Kozma P AD - ThromboGenics NV, Leuven, Belgium. FAU - Rosberger, Daniel F AU - Rosberger DF AD - Weill-Cornell Medical College, MaculaCare, PLLC, New York, New York. FAU - MacCumber, Mathew AU - MacCumber M AD - Illinois Retina Associates, Chicago, Illinois; Rush University Medical Center, Chicago, Illinois. FAU - Boyer, David S AU - Boyer DS AD - Retina-Vitreous Associates Medical Group, Los Angeles, California; University of Southern California/Keck School of Medicine, Los Angeles, California. FAU - Pieramici, Dante J AU - Pieramici DJ AD - California Retina Consultants, Santa Barbara, California; California Retina Research Foundation, Santa Barbara, California. LA - eng SI - ClinicalTrials.gov/NCT02079883 PT - Clinical Trial, Phase IV PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20180725 PL - United States TA - Ophthalmol Retina JT - Ophthalmology. Retina JID - 101695048 RN - 0 (Peptide Fragments) RN - 7V6HE3DM5A (microplasmin) RN - EC 3.4.21.7 (Fibrinolysin) SB - IM MH - Aged MH - Female MH - Fibrinolysin/*administration & dosage MH - Follow-Up Studies MH - Humans MH - Intravitreal Injections MH - Male MH - Peptide Fragments/*administration & dosage MH - Prospective Studies MH - Retinal Perforations/complications/diagnosis/*drug therapy MH - Tomography, Optical Coherence/methods MH - Treatment Outcome MH - *Visual Acuity MH - Vitreous Body/*pathology MH - Vitreous Detachment/complications/diagnosis/*drug therapy EDAT- 2019/04/03 06:00 MHDA- 2019/12/18 06:00 CRDT- 2019/04/03 06:00 PHST- 2017/12/21 00:00 [received] PHST- 2018/07/13 00:00 [revised] PHST- 2018/07/19 00:00 [accepted] PHST- 2019/04/03 06:00 [entrez] PHST- 2019/04/03 06:00 [pubmed] PHST- 2019/12/18 06:00 [medline] AID - S2468-6530(17)30672-3 [pii] AID - 10.1016/j.oret.2018.07.011 [doi] PST - ppublish SO - Ophthalmol Retina. 2019 Jan;3(1):32-41. doi: 10.1016/j.oret.2018.07.011. Epub 2018 Jul 25.