Arshad M Khanani1, Jay S Duker2, Jeffrey S Heier3, Peter K Kaiser4, Brian C Joondeph5, Petra Kozma6, Daniel F Rosberger7, Mathew MacCumber8, David S Boyer9, Dante J Pieramici10. 1. Sierra Eye Associates, Reno, Nevada. Electronic address: arshad.khanani@gmail.com. 2. New England Eye Center, Boston, Massachusetts; Tufts University School of Medicine, Boston, Massachusetts. 3. Ophthalmic Consultants of Boston, Boston, Massachusetts. 4. Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio. 5. Colorado Retina Associates, PC, Denver, Colorado. 6. ThromboGenics NV, Leuven, Belgium. 7. Weill-Cornell Medical College, MaculaCare, PLLC, New York, New York. 8. Illinois Retina Associates, Chicago, Illinois; Rush University Medical Center, Chicago, Illinois. 9. Retina-Vitreous Associates Medical Group, Los Angeles, California; University of Southern California/Keck School of Medicine, Los Angeles, California. 10. California Retina Consultants, Santa Barbara, California; California Retina Research Foundation, Santa Barbara, California.
Abstract
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.
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.
Authors: Thomas Bertelmann; Lars Berndzen; Thomas Raber; Sebastian Pfeiffer; Andreas Leha; Christoph Paul; Nicolas Feltgen; Sebastian Bemme Journal: Sci Rep Date: 2021-12-16 Impact factor: 4.379
Authors: Arshad M Khanani; Ryan N Constantine; Koenraad H Blot; Benedicte Lescrauwaet; Peter Szurman Journal: Acta Ophthalmol Date: 2020-12-26 Impact factor: 3.761
Authors: David H W Steel; Niall Patton; Theodor Stappler; Niral Karia; Hans Hoerauf; Nishal Patel; Joachim Wachtlin; Thomas Raber; Petra Kozma-Wiebe Journal: Retina Date: 2021-02-01 Impact factor: 3.975
Authors: Kimberly A Drenser; Dante J Pieramici; Joseph M Gunn; Daniel F Rosberger; Petra Kozma; Mitchell S Fineman; Luc Duchateau; Arshad M Khanani Journal: Clin Ophthalmol Date: 2021-07-16