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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT01429441
First received: September 2, 2011
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Vitreomacular Adhesion Including Macular Hole
Drug: Ocriplasmin
Other: Sham injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by ThromboGenics:

Primary Outcome Measures:
  • Proportion of subjects with pharmacological VMA resolution at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: October 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ocriplasmin Drug: Ocriplasmin
0.125 mg single intravitreal injection
Sham Comparator: Sham injection Other: Sham injection
Sham injection

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429441

Locations
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
ThromboGenics
  More Information

No publications provided

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT01429441     History of Changes
Other Study ID Numbers: TG-MV-014
Study First Received: September 2, 2011
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tissue Adhesions
Retinal Perforations
Cicatrix
Fibrosis
Pathologic Processes
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014