Vitreomacular Adhesion Including Macular HolePhase 3OASISNCT01429441

Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

A Phase 3 study testing Ocriplasmin in people with Vitreomacular Adhesion Including Macular Hole, run by ThromboGenics at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Vitreomacular Adhesion Including Macular Hole
What is being tested?: Ocriplasmin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 220 participants
Where: 25 sitesUnited States
Study dates: Oct 2011to Oct 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

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

Other trials in United States

About this study

Official title: A Randomized, Sham-controlled, Double-masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

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

Read the 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.

Conditions: Vitreomacular Adhesion Including Macular Hole
Being tested: Ocriplasmin, Sham injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OcriplasminDrug
0.125 mg single intravitreal injection
Sham injectionOther
Sham injection

Study groups in NCT01429441
Study group	Role	What they receive
Ocriplasmin	Experimental	Not described Receives: Drug: Ocriplasmin
Sham injection	Sham comparator	Not described Receives: Other: Sham injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 28

Secondary outcomes (1)

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.
Measured: Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Oct 2014

First posted7 Sep 2011 (estimated)
Study startOct 2011
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Vitreomacular Adhesion Including Macular HoleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01429441
Sponsor's protocol ID: TG-MV-014
Acronym: OASIS
Status last verified: Jan 2016
First submitted: 2 Sep 2011
Last updated: 14 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 34250257
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.
PubMed 30350717

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Sham-controlled, Double-masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
ClinicalTrials.gov ID: NCT01429441
Acronym / sponsor ID: OASIS / TG-MV-014
Conditions: Vitreomacular Adhesion Including Macular Hole
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: ThromboGenicsIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 7 Sep 2011 (estimated)
Results: Posted 11 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ocriplasmin	Experimental	Drug: Ocriplasmin
Sham injection	Sham comparator	Other: Sham injection

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ocriplasmin0.125 mg single intravitreal injection	Drug	Ocriplasmin
Sham injectionSham injection	Other	Sham injection

Primary outcome

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.

1 secondary outcome

Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24
Time frame: Month 24

Results and safety

Results posted to the registry on 11 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ocriplasmin	146	108
Sham	74	51

Primary outcome: Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28

Time frame: Day 28. Number (95% Confidence Interval). Unit: Percentage (weighted across strata)

Measure	Ocriplasmin n = 145	Sham n = 73
Value	41.7 (33.7 to 49.8)	6.2 (0.9 to 11.6)

Population analysed: Full Analysis Set (FAS): The FAS is the set of all randomized subjects who received the initial treatment, and for whom data of at least 1 post-injection efficacy assessment was present. Two (2) subjects (1 in each treatment group) were excluded from the FAS as they withdrew consent and did not attend any of the post-injection visits.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from the injection day (Day 0) up to discontinuation from the study or completion of the study (Month 24).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ocriplasmin	49 of 146 (33.6%)	132 of 146 (90.4%)	Not reported
Sham	27 of 74 (36.5%)	57 of 74 (77%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34250257Velaga 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.
Derived from this study: PubMed 30350717Yu 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ocriplasmin in people with Vitreomacular Adhesion Including Macular Hole, run by ThromboGenics at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01429441, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.