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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT01429441
First received: September 2, 2011
Last updated: November 6, 2014
Last verified: November 2014

September 2, 2011
November 6, 2014
October 2011
October 2014   (final data collection date for primary outcome measure)
Proportion of subjects with pharmacological VMA resolution at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
VMA resolution [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01429441 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
A Randomized, Sham-controlled, Double-masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Vitreomacular Adhesion Including Macular Hole
  • Drug: Ocriplasmin
    0.125 mg single intravitreal injection
  • Other: Sham injection
    Sham injection
  • Experimental: Ocriplasmin
    Intervention: Drug: Ocriplasmin
  • Sham Comparator: Sham injection
    Intervention: Other: Sham injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01429441
TG-MV-014
Yes
ThromboGenics
ThromboGenics
Not Provided
Not Provided
ThromboGenics
November 2014

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