Table 3Details of Included Studies

TG-MV-004TG-MV-006TG-MV-007
Designs and PopulationsStudy designDouble-mask RCTDouble-mask RCTDouble-mask RCT
LocationsBelgium and GermanyUSUS and European Union
Randomized (N)60326326
Inclusion criteria
  • Adults (≥ 18 years of age)
  • Symptomatic focal VMA (including VMT with and without FTMH)
  • BCVA ≤ 20/40 in study eye, ≥ 20/400 in non-study eye
  • Adults (≥ 18 years of age)
  • Symptomatic focal VMA
  • BCVA ≤ 20/25 in study eye, ≥ 20/800 in non-study eye
  • Adults (≥ 18 years of age)
  • Symptomatic focal VMA
  • BCVA ≤ 20/25 in study eye, ≥ 20/800 in non-study eye
Exclusion criteria
DrugsInterventionOcriplasmin, single dose 75 mcg, 125 mcg, 175 mcg, or repeat dose of 125 mcg, intravitreal injectionOcriplasmin, single dose 125 mcgOcriplasmin, single dose 125 mcg
Comparator(s)Sham injectionPlacebo (0.1 mL vehicle) intravitreal injectionPlacebo (0.1 mL vehicle) intravitreal injection
DurationPhase
Run-inNANANA
Double-blind6 months6 months6 months
Follow-upNA~ 2 years (TG-MV-012)~ 2 years (TG-MV-012)
OutcomesPrimary end pointTotal PVD at day 14Resolution of VMA at day 28, 3 months, and 6 monthsResolution of VMA at day 28, 3 months, and 6 months
Other end points
  • Resolution of VMA at day 28, 3 months, and 6 months
  • Non-surgical closure of FTMH at day 28 and 6 months
  • Avoidance of vitrectomy at day 28 and 6 months
  • Change in baseline BCVA at day 28
  • Total PVD at day 28
  • Non-surgical closure of FTMH at day 28 and 6 months
  • Avoidance of vitrectomy at day 28 and 6 months
  • Change in baseline BCVA at day 28 and 6 months
  • Change in baseline QoL (VFQ-25) at 6 months
  • Total PVD at day 28
  • Non-surgical closure of FTMH at day 28 and 6 months
  • Avoidance of vitrectomy at day 28 and 6 months
  • Change in baseline BCVA at day 28 and 6 months
  • Change in baseline QoL (VFQ-25) at 6 months
NotesPublicationsStalmans et al. (2010)35Stalmans et al. (2012)19Stalmans et al. (2012)19

BCVA = best-corrected visual acuity; FTMH = full-thickness macular hole; NA = not applicable; RCT = randomized controlled trial; PVD = posterior vitreous detachment; QoL = quality of life; VMA = vitreomacular adhesion; VMT = vitreomacular traction.

Note: Five additional reports were included: Clinical Study Reports,46 United States Food and Drug Administration Medical and Statistical Reports,36,37 Common Drug Review Submission Binder.38

From: 3, RESULTS

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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