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Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01429441
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : January 11, 2016
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
ThromboGenics

Tracking Information
First Submitted Date  ICMJE September 2, 2011
First Posted Date  ICMJE September 7, 2011
Results First Submitted Date  ICMJE October 29, 2015
Results First Posted Date  ICMJE January 11, 2016
Last Update Posted Date March 14, 2016
Study Start Date  ICMJE October 2011
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2015)
Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28 [ Time Frame: Day 28 ]
Pharmacological VMA resolution without anatomical defect, based on SD-OCT and determined by the masked central reading center (CRC), with post-resolution vitrectomy considered as a failure. Missing data were imputed using the last observation carried forward (LOCF) method.
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2011)
VMA resolution [ Time Frame: Day 28 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2015)
Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24 [ Time Frame: Month 24 ]
≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
Official Title  ICMJE A Randomized, Sham-controlled, Double-masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
Brief Summary The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.
Detailed Description The present study is designed to assess anatomical and functional outcomes following a single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic vitreomacular adhesion (VMA)/ (VMT) including macular hole.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vitreomacular Adhesion Including Macular Hole
Intervention  ICMJE
  • Drug: Ocriplasmin
    0.125 mg single intravitreal injection
  • Other: Sham injection
    Sham injection
Study Arms  ICMJE
  • Experimental: Ocriplasmin
    Intervention: Drug: Ocriplasmin
  • Sham Comparator: Sham injection
    Intervention: Other: Sham injection
Publications * Yu TM, Dugel PU, Haller JA, Kaiser PK, Arnold RJ. Budget impact analysis of ocriplasmin for the treatment of symptomatic vitreomacular adhesion in the USA. J Comp Eff Res. 2018 Dec;7(12):1195-1207. doi: 10.2217/cer-2018-0057. Epub 2018 Oct 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2012)
220
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2011)
150
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects 18 years of age or older and of either gender
  • Presence of vitreomacular adhesion
  • Best corrected visual acuity (BCVA) of 20/32 or worse in study eye
  • BCVA of 20/800 or better in the non-study eye

Exclusion Criteria:

  • History or current evidence of proliferative retinopathy, exudative age-related macular degeneration (AMD) or retinal vein occlusion in the study eye
  • Any vitreous hemorrhage or any other vitreous opacification which precludes the visualization of the posterior pole by visual inspection OR adequate assessment of the macula by spectral-domain optical coherence tomography (SD-OCT) in the study eye
  • Macular hole of > 400 µm diameter in the study eye
  • Presence of epiretinal membrane (ERM)
  • Aphakia in the study eye
  • High myopia (more than 8D) in study eye
  • History of rhegmatogenous retinal detachment in either eye
  • History of vitrectomy in the study eye
  • Previous participation in this trial or prior administration of ocriplasmin in the study eye
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01429441
Other Study ID Numbers  ICMJE TG-MV-014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ThromboGenics
Study Sponsor  ICMJE ThromboGenics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ThromboGenics
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP