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Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS)
This study has been completed.
Sponsor:
ThromboGenics
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT01429441
First received: September 2, 2011
Last updated: February 18, 2016
Last verified: January 2016
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
MedlinePlus related topics:
Adhesions
Drug Information available for:
Ocriplasmin
U.S. FDA Resources
Further study details as provided by ThromboGenics:
Primary Outcome Measures:
- 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:
- 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.
| Enrollment: | 220 |
| Study Start Date: | October 2011 |
| Study Completion Date: | October 2014 |
| Primary Completion Date: | October 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 (Adult, Senior) |
| 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
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
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
| Responsible Party: | ThromboGenics |
| ClinicalTrials.gov Identifier: | NCT01429441 History of Changes |
| Other Study ID Numbers: |
TG-MV-014 |
| Study First Received: | September 2, 2011 |
| Results First Received: | October 29, 2015 |
| Last Updated: | February 18, 2016 |
Additional relevant MeSH terms:
|
Tissue Adhesions Retinal Perforations Cicatrix Fibrosis |
Pathologic Processes Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on July 17, 2017