Table 2Inclusion Criteria for the Systematic Review

Patient PopulationAdult patients (≥ 18 years of age) with sVMA
Subpopulation:
  • Individuals with FTMH at baseline
  • ≥ 65 and < 65 years of age
  • Baseline BCVA score
InterventionOcriplasmin 125 mcg (in 0.1 mL of diluted solution) administered by intravitreal injection to the affected eye once as a single dose
Comparators
  • Placebo or sham injection
  • Vitrectomy
  • “Watchful waiting”
OutcomesKey efficacy outcomes:
  • Prevention of blindness
  • Resolution of VMA
  • HRQoL
Other efficacy outcomes:
  • Total PVD
  • Non-surgical closure of FTMH
  • Proportion of patients receiving vitrectomy (avoidance of vitrectomy)
  • Change from baseline in BCVAa
Harms outcomes:
Study DesignPublished and unpublished double-masked RCTs

AE = adverse event; BCVA = best-corrected visual acuity; FTMH = full-thickness macular hole; HRQoL = health-related quality of life; OCT = optical clearance tomography; PVD = posterior vitreous detachment; RCT = randomized controlled trial; SAE = serious adverse event; sVMA = symptomatic vitreomacular adhesion; VMA = vitreomacular adhesion; WDAE = withdrawal due to adverse event.

a

Absolute change, percentage of patients with improvement or worsening from baseline of ≥ 15 letters visual acuity, and percentage of patients with severe vision loss (loss of ≥ 30 letters visual acuity).

From: 2, OBJECTIVES AND METHODS

Cover of Ocriplasmin (Jetrea) (125 mcg Intravitreal Injection)
Ocriplasmin (Jetrea) (125 mcg Intravitreal Injection): For the Treatment of Symptomatic Vitreomacular Adhesion [Internet].
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