March 2012
Volume 53, Issue 14
Free
ARVO Annual Meeting Abstract  |   March 2012
The Phase III MIVI-TRUST Clinical Trial Data: Subgroup Responder Analysis of a Single Intravitreal Injection of Ocriplasmin in patients with Full Thickness Macular Hole
Author Affiliations & Notes
  • Dante J. Pieramici
    California Retina Consultants and Research Foundation, Santa Barbara, California
  • David S. Boyer
    Ophthalmology, Retina Vitreous Assoc Med Group, Los Angeles, California
  • Footnotes
    Commercial Relationships  Dante J. Pieramici, Alimera (C, R), Allergan (F), Genentech (F, C, R), Regeneron (F), Thrombogenics (F, C, R); David S. Boyer, Alcon (F, C, R), Allergan (F, C, R), Genentech (C, R), Genetech (F), iCo (F), Neurotech (C), Novartis (R), Novartis/QLT (C), Pfizer (R), Regeneron (F, C, R)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science March 2012, Vol.53, 947. doi:
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      Dante J. Pieramici, David S. Boyer; The Phase III MIVI-TRUST Clinical Trial Data: Subgroup Responder Analysis of a Single Intravitreal Injection of Ocriplasmin in patients with Full Thickness Macular Hole. Invest. Ophthalmol. Vis. Sci. 2012;53(14):947.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : The purpose of the MIVI-TRUST Phase III program was to investigate the effect of a single intravitreal injection of ocriplasmin for the resolution of symptomatic vitreomacular adhesion (VMA). An important secondary endpoint included non-surgical closure of full thickness macular hole (FTMH). The pathogenesis of which has been related to the progression of tractional forces caused by unresolved vitreomacular adhesion.

Methods: : 153 of a total 652 treated eyes had FTMH at baseline. Of these, 106 eyes were randomized to receive a single intravitreal injection of ocriplasmin 125µg (100µl) and 47 eyes received placebo (100µl). Assessments included best corrected visual acuity (ETDRS letters), optical coherence tomography and review of adverse events.

Results: : VMA resolution was achieved in 50.0% of ocriplasmin-treated eyes, compared with 25.5% of placebo-treated eyes (p=0.006). At day 28, 40.6% of the ocriplasmin-treated eyes demonstrated nonsurgical FTMH closure as compared to 10.6% (p 250 µm, was 58.3% and 24.6%, respectively. Visual acuity improvements of ≥2 and ≥3 lines in ocriplasmin-treated patients with nonsurgical FTMH-closure were 76.7% and 51.2%, respectively, at month 6. A majority of adverse events occurred within the first 7 days of treatment. For example, the incidence of floaters was 12.9% in the first week and 3.9% between one week and study end at 6 months. No cases of endophthalmitis were observed.

Conclusions: : A single intravitreal dose of 125 µg of ocriplasmin achieved FTMH closure in approximately 40% of patients. Pharmacologic resolution of this anatomic defect resulted in clinically significant visual acuity benefit in patients with FTMH. Treatment was well tolerated by patients. Ocriplasmin could provide a minimally invasive pharmacologic approach to treat patients with FTMH.

Clinical Trial: : http://www.clinicaltrials.gov NCT00798317

Keywords: vitreous • retina • vitreous substitutes 
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