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

Primary Purpose

Vitreomacular Adhesion Including Macular Hole

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ocriplasmin
Sham injection
Sponsored by
ThromboGenics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitreomacular Adhesion Including Macular Hole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retinal Consultants of Arizona
  • Retina-Vitreous Associates Medical Group
  • Retina Consultants Medical Group
  • West Coast Retina Group, Inc
  • Bay Area Retina Associates
  • MedEye Associates
  • Center for Retina and Macular Disease
  • Associated Retinal Consultants
  • Sabates Eye Center Research
  • Eyesite Opthalmic Services, PA
  • Retina-Vitreous Center, PA
  • Retina Association of NJ
  • Retina Vitrous Surgeons of CNY
  • Southeast Clinical Research, PA
  • Cincinnati Eye Institute
  • Retina Associates of Cleveland
  • Mid Atlantic Retina
  • Texas Retina Associates
  • Retina Research Center
  • Texas Retina Associates
  • Retina Consultants, PA
  • Vitroretinal Consultants
  • Valley Retina Institute, P.A.
  • Retina Consultants of San Antonio
  • Eye Care Associate

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ocriplasmin

Sham injection

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24
≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method.

Full Information

First Posted
September 2, 2011
Last Updated
February 18, 2016
Sponsor
ThromboGenics
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1. Study Identification

Unique Protocol Identification Number
NCT01429441
Brief Title
Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
Acronym
OASIS
Official Title
A Randomized, Sham-controlled, Double-masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ThromboGenics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreomacular Adhesion Including Macular Hole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ocriplasmin
Arm Type
Experimental
Arm Title
Sham injection
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Ocriplasmin
Intervention Description
0.125 mg single intravitreal injection
Intervention Type
Other
Intervention Name(s)
Sham injection
Intervention Description
Sham injection
Primary Outcome Measure Information:
Title
Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28
Description
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.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24
Description
≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method.
Time Frame
Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Retinal Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retina Consultants Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
West Coast Retina Group, Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
MedEye Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Associated Retinal Consultants
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Sabates Eye Center Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Eyesite Opthalmic Services, PA
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Retina-Vitreous Center, PA
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Retina Association of NJ
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Retina Vitrous Surgeons of CNY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
Country
United States
Facility Name
Southeast Clinical Research, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Retina Associates of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Mid Atlantic Retina
City
Huntingdon Valley
State/Province
Pennsylvania
ZIP/Postal Code
19006
Country
United States
Facility Name
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Retina Consultants, PA
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Vitroretinal Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Valley Retina Institute, P.A.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Retina Consultants of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Eye Care Associate
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34250257
Citation
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.
Results Reference
derived
PubMed Identifier
30350717
Citation
Yu 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.
Results Reference
derived

Learn more about this trial

Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

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