Symptomatic Vitreomacular AdhesionPhase 3NCT01889251

A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion

A Phase 3 study testing Ocriplasmin in people with Symptomatic Vitreomacular Adhesion, run by Alcon Research at 1 site in Japan.

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 superiority regarding vitreomacular adhesion (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to sham-injection in subjects with symptomatic VMA. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Symptomatic Vitreomacular Adhesion
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: 251 participants
Where: 1 siteJapan
Study dates: Jul 2013to Sep 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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Symptomatic vitreomacular adhesion (VMA) which, in the opinion of the Investigator, is related to decreased visual function;
Best corrected visual acuity (BCVA) of 20/25 or worse in the study eye;
BCVA of 20/800 or better in the non-study eye;
Provide written informed consent;
Follow specified instructions during study period;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Evidence of proliferative retinopathy, exudative age-related macular degeneration, or retinal vein occlusion in the study eye;
Vitreous hemorrhage or other opacification;
High myopia in the study eye;
Ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior 3 months;
Uncontrolled glaucoma in the study eye;
History of retinal detachment in either eye;

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Active infection in either eye;
Pregnant or of child-bearing potential and not utilizing acceptable form of contraception;
Participation in another investigational drug study within 30 days prior to this study;
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Contact Alcon for Trial Locations
Tokyo

Other trials in Japan

About this study

Official title: A Phase III Study of A01016 125μg Intravitreal Injection in Subjects With Symptomatic Vitreomacular Adhesion - Comparison Study to Sham Injection

Conditions: Symptomatic Vitreomacular Adhesion
Being tested: Ocriplasmin, Sham injection
Keywords: Vitreomacular Adhesion, Vitreomacular Traction, Vitreomacular Traction Syndrome, Vitrectomy, Central Visual Field Defect, Blind Spot, Intravitreal Injection, Macula, Retina, Decreased Visual Acuity, Visual Complaint, SD-OCT, Macular Hole
Medical subject headings: Scotoma, Retinal Perforations

What participants receive

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

OcriplasminDrug
Also called A01016
Sham injectionDrug

Study groups in NCT01889251
Study group	Role	What they receive
Ocriplasmin	Experimental	Ocriplasmin administered as a single intravitreal injection to the study eye at baseline Receives: Drug: Ocriplasmin
Sham injection	Sham comparator	Single sham injection to the study eye at baseline Receives: Drug: Sham injection

What is being measured

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

Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)
VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage.
Measured: Day 28

Timeline

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

Jul 2013Sep 2014

First posted28 Jun 2013 (estimated)
Study startJul 2013
Primary completionSep 2014
Study completionSep 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.
Other trials for Symptomatic Vitreomacular AdhesionStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 251 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01889251
Sponsor's protocol ID: J-12-075
Status last verified: Nov 2015
First submitted: 26 Jun 2013
Last updated: 30 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Study of A01016 125μg Intravitreal Injection in Subjects With Symptomatic Vitreomacular Adhesion - Comparison Study to Sham Injection
ClinicalTrials.gov ID: NCT01889251
Acronym / sponsor ID: J-12-075
Conditions: Symptomatic Vitreomacular Adhesion
Keywords: Vitreomacular Adhesion, Vitreomacular Traction, Vitreomacular Traction Syndrome, Vitrectomy, Central Visual Field Defect, Blind Spot, Intravitreal Injection, Macula
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 251 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 28 Jun 2013 (estimated)
Results: Posted 29 Oct 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Ocriplasmin	Experimental	Drug: OcriplasminOcriplasmin administered as a single intravitreal injection to the study eye at baseline
Sham injection	Sham comparator	Drug: Sham injectionSingle sham injection to the study eye at baseline

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Symptomatic vitreomacular adhesion (VMA) which, in the opinion of the Investigator, is related to decreased visual function;
Best corrected visual acuity (BCVA) of 20/25 or worse in the study eye;
BCVA of 20/800 or better in the non-study eye;
Provide written informed consent;
Follow specified instructions during study period;

Key exclusion criteria (10 listed)

Evidence of proliferative retinopathy, exudative age-related macular degeneration, or retinal vein occlusion in the study eye;
Vitreous hemorrhage or other opacification;
High myopia in the study eye;
Ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior 3 months;
Uncontrolled glaucoma 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
OcriplasminAlso: A01016	Drug	Ocriplasmin
Sham injection	Drug	Sham injection

Primary outcome

Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)
Time frame: Day 28
VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage.

Results and safety

Results posted to the registry on 29 Oct 2015, 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	115	114
Sham Injection	57	57

Primary outcome: Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)

Time frame: Day 28. Number. Unit: percentage of subjects

Measure	Ocriplasmin n = 115	Sham Injection n = 57
Value	52.2	1.8

Population analysed: This analysis population includes all subjects who received study medication, completed at least 1 on-therapy study visit and had symptomatic VMA at baseline, as randomized, based on an intent to treat approach.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (1 year, 2 months). This analysis group includes all subjects who received study medication, as treated. Note: One subject randomized to Ocriplasmin was inadvertently treated with Sham.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ocriplasmin	23 of 114 (20.2%)	63 of 114 (55.3%)	Not reported
Sham Injection	4 of 58 (6.9%)	19 of 58 (32.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Group Manager, Clinical Development study director

Alcon Japan, Ltd.

1 site 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 Symptomatic Vitreomacular Adhesion, run by Alcon Research at 1 site in Japan.

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 6 inclusion and 10 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 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. 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 29 Oct 2015). 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 Non-Surgical Resolution of Vitreomacular Adhesion (VMA) (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 NCT01889251.

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 30 Nov 2015.