Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
OASIS
A Randomized, Sham-controlled, Double-masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
1 other identifier
interventional
220
1 country
25
Brief Summary
The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2011
Typical duration for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2011
CompletedFirst Posted
Study publicly available on registry
September 7, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
January 11, 2016
CompletedMarch 14, 2016
January 1, 2016
3 years
September 2, 2011
October 29, 2015
February 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at 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.
Day 28
Secondary Outcomes (1)
Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24
Month 24
Study Arms (2)
Ocriplasmin
EXPERIMENTALSham injection
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ThromboGenicslead
Study Sites (25)
Retinal Consultants of Arizona
Phoenix, Arizona, 85014, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Retina Consultants Medical Group
Sacramento, California, 95819, United States
West Coast Retina Group, Inc
San Francisco, California, 94107, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
MedEye Associates
Miami, Florida, 33143, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, United States
Associated Retinal Consultants
Royal Oak, Michigan, 48073, United States
Sabates Eye Center Research
Kansas City, Missouri, 64108, United States
Eyesite Opthalmic Services, PA
Portsmouth, New Hampshire, 03801, United States
Retina-Vitreous Center, PA
New Brunswick, New Jersey, 08901, United States
Retina Association of NJ
Teaneck, New Jersey, 07666, United States
Retina Vitrous Surgeons of CNY
Syracuse, New York, 13224, United States
Southeast Clinical Research, PA
Charlotte, North Carolina, 28210, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Retina Associates of Cleveland
Cleveland, Ohio, 44130, United States
Mid Atlantic Retina
Huntingdon Valley, Pennsylvania, 19006, United States
Texas Retina Associates
Arlington, Texas, 76012, United States
Retina Research Center
Austin, Texas, 78705, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Retina Consultants, PA
Fort Worth, Texas, 76104, United States
Vitroretinal Consultants
Houston, Texas, 77030, United States
Valley Retina Institute, P.A.
McAllen, Texas, 78503, United States
Retina Consultants of San Antonio
San Antonio, Texas, 78240, United States
Eye Care Associate
Tyler, Texas, 75701, United States
Related Publications (2)
Velaga SB, Nittala MG, Ip MS, Duchateau L, Sadda SR. Post hoc analysis of ellipsoid zone changes beyond the central subfield in symptomatic vitreomacular adhesion patients from the OASIS trial. BMJ Open Ophthalmol. 2021 Jun 21;6(1):e000648. doi: 10.1136/bmjophth-2020-000648. eCollection 2021.
PMID: 34250257DERIVEDYu TM, Dugel PU, Haller JA, Kaiser PK, Arnold RJ. Budget impact analysis of ocriplasmin for the treatment of symptomatic vitreomacular adhesion in the USA. J Comp Eff Res. 2018 Dec;7(12):1195-1207. doi: 10.2217/cer-2018-0057. Epub 2018 Oct 23.
PMID: 30350717DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Dr. Petra Kozma-Wiebe
- Organization
- ThromboGenics N.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2011
First Posted
September 7, 2011
Study Start
October 1, 2011
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
March 14, 2016
Results First Posted
January 11, 2016
Record last verified: 2016-01