PMID- 26398685
OWN - NLM
STAT- MEDLINE
DCOM- 20160923
LR  - 20161126
IS  - 1539-2864 (Electronic)
IS  - 0275-004X (Linking)
VI  - 36
IP  - 3
DP  - 2016 Mar
TI  - A RANDOMIZED, PLACEBO-CONTROLLED STUDY OF INTRAVITREAL OCRIPLASMIN IN PEDIATRIC 
      PATIENTS SCHEDULED FOR VITRECTOMY.
PG  - 565-75
LID - 10.1097/IAE.0000000000000771 [doi]
AB  - PURPOSE: To evaluate safety and preliminary efficacy of 175 mug of intravitreal 
      ocriplasmin in pediatric patients scheduled for vitrectomy. METHODS: Based on a 
      single-center, prospective, randomized, placebo-controlled, and double-masked 
      Phase 2 study, 22 pediatric patients scheduled for vitrectomy were randomized 2:1 
      to 175-mug ocriplasmin injection or placebo. Treatment was administered 
      midvitreous 30 minutes to 60 minutes before vitrectomy. Safety was assessed by 
      reported adverse events (AEs), ophthalmologic examinations, fundus photography, 
      and fluorescein angiography. The primary efficacy endpoint was the proportion of 
      eyes with total macular posterior vitreous detachment before vitrectomy or after 
      application of suction. Secondary endpoints included vitreous liquefaction 
      assessment before vitrectomy and immediate postoperative retinal reattachment. 
      RESULTS: All patients experienced at least 1 AE. Most AEs were ocular and 
      occurred in the study eye. Serious AEs were reported for 2 of 16 eyes (3.4%) in 
      the ocriplasmin group and 2 of 8 eyes (11.1%) in the placebo group. One case of 
      lens subluxation due to zonular disruption was observed in the ocriplasmin group. 
      A clear efficacy signal was not observed. CONCLUSION: Intravitreal injection of 
      175 mug of ocriplasmin was tolerated in pediatric patients before vitrectomy; 
      however, the small sample size in this study precluded adequate efficacy 
      comparisons. AEs reported were consistent with those anticipated in pediatric 
      patients.
FAU - Drenser, Kimberly
AU  - Drenser K
AD  - *Associated Retinal Consultants, Royal Oak, Michigan; daggerNightstaRx Ltd, London, 
      United Kingdom (formerly of ThromboGenics NV, Leuven, Belgium).
FAU - Girach, Aniz
AU  - Girach A
FAU - Capone, Antonio Jr
AU  - Capone A Jr
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Retina
JT  - Retina (Philadelphia, Pa.)
JID - 8309919
RN  - 0 (Fibrinolytic Agents)
RN  - 0 (Peptide Fragments)
RN  - 7V6HE3DM5A (microplasmin)
RN  - EC 3.4.21.7 (Fibrinolysin)
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Child, Preschool
MH  - Double-Blind Method
MH  - Female
MH  - Fibrinolysin/*administration & dosage/adverse effects
MH  - Fibrinolytic Agents/*administration & dosage/adverse effects
MH  - Fluorescein Angiography
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Intravitreal Injections
MH  - Male
MH  - Peptide Fragments/*administration & dosage/adverse effects
MH  - Prospective Studies
MH  - Retinal Diseases/physiopathology/*surgery
MH  - Visual Acuity/physiology
MH  - *Vitrectomy
MH  - Vitreous Body/drug effects
MH  - Vitreous Detachment/etiology/physiopathology
EDAT- 2015/09/24 06:00
MHDA- 2016/09/24 06:00
CRDT- 2015/09/24 06:00
PHST- 2015/09/24 06:00 [entrez]
PHST- 2015/09/24 06:00 [pubmed]
PHST- 2016/09/24 06:00 [medline]
AID - 10.1097/IAE.0000000000000771 [doi]
PST - ppublish
SO  - Retina. 2016 Mar;36(3):565-75. doi: 10.1097/IAE.0000000000000771.