Vitreomacular TractionPhase 2NCT00435539

A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt)

A Phase 2 study testing ocriplasmin in people with Vitreomacular Traction, run by ThromboGenics at 4 sites in 2 countries.

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

A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Vitreomacular Traction
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: 60 participants
Where: 4 sitesin 2 countries
Study dates: Feb 2007to Feb 2009
Phase: Phase 2
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

Patients >_ 18 years of age with vitreomacular traction

Who cannot join

PVD present at baseline
Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
Vitreous hemorrhage
Patients who have had a vitrectomy in the study eye at any time

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Belgium3 sites

ZNA OCMW Antwerpen
Antwerp, 2020
University Hospital of Ghent
Ghent, B-9000
Universitaire Ziekenhuizen K.U.Leuven
Leuven

Other trials in Belgium

Germany1 site

Augenklinik der Universitat Munchen
München, 80336

Other trials in Germany

About this study

Official title: A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical Posterior Vitreous Detachment (PVD) Induction for Treatment of Vitreomacular Traction (VMT).

A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.

Conditions: Vitreomacular Traction
Being tested: ocriplasmin, Sham Comparator
Keywords: Vitreomacular Traction, Maculopathy, VMT, PVD
Medical subject headings: Macular Degeneration

What participants receive

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

ocriplasminDrug
Also called microplasmin
Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.
ocriplasminDrug
Also called microplasmin
Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.
Sham ComparatorDrug
Also called microplasmin
Intravitreal sham injection

Study groups in NCT00435539
Study group	Role	What they receive
ocriplasmin 75µg single injection	Experimental	Ocriplasmin 75µg single injection versus sham injection Receives: Drug: ocriplasmin
ocriplasmin 125µg single injection	Experimental	Ocriplasmin 125µg single injection versus sham injection Receives: Drug: ocriplasmin
ocriplasmin 175µg single injection	Experimental	Ocriplasmin 175µg single injection versus sham injection Receives: Drug: ocriplasmin
ocriplasmin 125µg multiple injections	Experimental	Ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125µg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125µg. Receives: Drug: ocriplasmin
sham injection	Sham comparator	sham injection Receives: Drug: Sham Comparator

What is being measured

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

Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging.
Measured: Day 14

Secondary outcomes (1)

Resolution of Vitreomacular Traction (Investigator's Assessment)
Resolution of VMT was evaluated by the investigator using optical coherence tomography (OCT).Resolution of VMT was defined as a change from baseline status of Yes to post-injection status of No and was evaluated by the investigator using OCT. Subjects undergoing vitrectomy had their last observation prior to vitrectomy carried forward.
Measured: Day 28

Timeline

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

Feb 2007Feb 2009

First posted15 Feb 2007 (estimated)
Study startFeb 2007
Primary completionJan 2009
Study completionFeb 2009

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 Vitreomacular TractionStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00435539
Sponsor's protocol ID: TG-MV-004
Other IDs: MIVI-IIT
Status last verified: Apr 2014
First submitted: 14 Feb 2007
Last updated: 17 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical Posterior Vitreous Detachment (PVD) Induction for Treatment of Vitreomacular Traction (VMT).
ClinicalTrials.gov ID: NCT00435539
Acronym / sponsor ID: TG-MV-004
Conditions: Vitreomacular Traction
Keywords: Vitreomacular Traction, Maculopathy, VMT, PVD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: ThromboGenicsIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Jan 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 15 Feb 2007 (estimated)
Results: Posted 13 Sep 2013

Clinical summary

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

A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
ocriplasmin 75µg single injection	Experimental	Drug: ocriplasminOcriplasmin 75µg single injection versus sham injection
ocriplasmin 125µg single injection	Experimental	Drug: ocriplasminOcriplasmin 125µg single injection versus sham injection
ocriplasmin 175µg single injection	Experimental	Drug: ocriplasminOcriplasmin 175µg single injection versus sham injection
ocriplasmin 125µg multiple injections	Experimental	Drug: ocriplasminOcriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125µg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125µg.
sham injection	Sham comparator	Drug: Sham Comparatorsham injection

Who may qualify

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

Key inclusion criteria (1 listed)

Patients >_ 18 years of age with vitreomacular traction

Key exclusion criteria (4 listed)

PVD present at baseline
Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
Vitreous hemorrhage
Patients who have had a vitrectomy in the study eye at any time

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: microplasminIntravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.	Drug	ocriplasmin 125µg single injection, ocriplasmin 175µg single injection, ocriplasmin 75µg single injection
ocriplasminAlso: microplasminIntravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.	Drug	ocriplasmin 125µg multiple injections
Sham ComparatorAlso: microplasminIntravitreal sham injection	Drug	sham injection

Primary outcome

Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging.
Time frame: Day 14

1 secondary outcome

Resolution of Vitreomacular Traction (Investigator's Assessment)
Time frame: Day 28

Results and safety

Results posted to the registry on 13 Sep 2013, 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 75µg Single Injection	12	12
Ocriplasmin 125µg Single Injection	13	13
Ocriplasmin 175µg Single Injection	11	11
Ocriplasmin 125µg Multiple Injections	12	12
Sham Injection	12	12

Primary outcome: Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging.

Time frame: Day 14. Number. Unit: percentage of participants

Measure	Ocriplasmin 75µg Single Injection n = 11	Ocriplasmin 175µg Single Injection n = 11	Ocriplasmin 125µg Pooled n = 22	Sham Injection n = 11
Value	18.2	18.2	13.6	0

Ocriplasmin 75µg Single Injection vs Sham Injection: p = 0.4762, Fisher Exact
Ocriplasmin 175µg Single Injection vs Sham Injection: p = 0.4762, Fisher Exact
Ocriplasmin 125µg Pooled vs Sham Injection: p = 0.5343, Fisher Exact

Population analysed: Intention to Treat (ITT)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs/SAEs were collected from injection day up to 6 months after injection. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ocriplasmin 75µg	3 of 12 (25%)	10 of 12 (83.3%)	Not reported
Ocriplasmin 125µg Single Injection	2 of 13 (15.4%)	10 of 13 (76.9%)	Not reported
Ocriplasmin 175µg Single Injection	3 of 11 (27.3%)	10 of 11 (90.9%)	Not reported
Ocriplasmin 125µg Multiple Injection	4 of 12 (33.3%)	11 of 12 (91.7%)	Not reported
Sham Injection	0 of 12 (0%)	9 of 12 (75%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
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.

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

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ocriplasmin in people with Vitreomacular Traction, run by ThromboGenics at 4 sites in 2 countries.

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 1 inclusion and 4 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 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium, Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 13 Sep 2013). 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 Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging. (time frame: Day 14). 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 NCT00435539.

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 17 Dec 2014.