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. Identifier: NCT01429441
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : January 11, 2016
Last Update Posted : March 14, 2016
Information provided by (Responsible Party):

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 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

Arm Intervention/treatment
Experimental: Ocriplasmin Drug: Ocriplasmin
0.125 mg single intravitreal injection

Sham Comparator: Sham injection Other: Sham injection
Sham injection

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.

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

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

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 identifier (NCT number): NCT01429441

United States, Arizona
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Retina Consultants Medical Group
Sacramento, California, United States, 95819
West Coast Retina Group, Inc
San Francisco, California, United States, 94107
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
United States, Florida
MedEye Associates
Miami, Florida, United States, 33143
Center for Retina and Macular Disease
Winter Haven, Florida, United States, 33880
United States, Michigan
Associated Retinal Consultants
Royal Oak, Michigan, United States, 48073
United States, Missouri
Sabates Eye Center Research
Kansas City, Missouri, United States, 64108
United States, New Hampshire
Eyesite Opthalmic Services, PA
Portsmouth, New Hampshire, United States, 03801
United States, New Jersey
Retina-Vitreous Center, PA
New Brunswick, New Jersey, United States, 08901
Retina Association of NJ
Teaneck, New Jersey, United States, 07666
United States, New York
Retina Vitrous Surgeons of CNY
Syracuse, New York, United States, 13224
United States, North Carolina
Southeast Clinical Research, PA
Charlotte, North Carolina, United States, 28210
United States, Ohio
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
Retina Associates of Cleveland
Cleveland, Ohio, United States, 44130
United States, Pennsylvania
Mid Atlantic Retina
Huntingdon Valley, Pennsylvania, United States, 19006
United States, Texas
Texas Retina Associates
Arlington, Texas, United States, 76012
Retina Research Center
Austin, Texas, United States, 78705
Texas Retina Associates
Dallas, Texas, United States, 75231
Retina Consultants, PA
Fort Worth, Texas, United States, 76104
Vitroretinal Consultants
Houston, Texas, United States, 77030
Valley Retina Institute, P.A.
McAllen, Texas, United States, 78503
Retina Consultants of San Antonio
San Antonio, Texas, United States, 78240
Eye Care Associate
Tyler, Texas, United States, 75701
Sponsors and Collaborators

Responsible Party: ThromboGenics Identifier: NCT01429441     History of Changes
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:
Tissue Adhesions
Retinal Perforations
Pathologic Processes
Retinal Diseases
Eye Diseases