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

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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

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

Condition or disease Intervention/treatment Phase
Vitreomacular Adhesion Including Macular Hole Drug: Ocriplasmin Other: Sham injection Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Sham-controlled, Double-masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
Study Start Date : October 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions
Drug Information available for: Ocriplasmin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ocriplasmin Drug: Ocriplasmin
0.125 mg single intravitreal injection
Sham Comparator: Sham injection Other: Sham injection
Sham injection


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429441


Locations
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Sponsors and Collaborators
ThromboGenics
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT01429441    
Other Study ID Numbers: TG-MV-014
First Posted: September 7, 2011    Key Record Dates
Results First Posted: January 11, 2016
Last Update Posted: March 14, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Retinal Perforations
Tissue Adhesions
Cicatrix
Fibrosis
 Pathologic Processes
Retinal Diseases
Eye Diseases