Diabetic Macular EdemaPhase 2MIVI-IINCT00412451
A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)
A Phase 2 study testing ocriplasmin in people with Diabetic Macular Edema, run by ThromboGenics at 15 sites in 6 countries.
Trial summary
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- 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
- 51 participants
- Where
- 15 sitesin 6 countries
- Study dates
- Dec 2006to Mar 2010
- 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 Diabetic Macular Edema
Who cannot join
- PVD present at baseline
- Vitreous hemorrhage
- Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
- Patients who have had a vitrectomy in the study eye at any time
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Italy4 sites
University of Milan
Milan
Azienda Ospedaliero-Universitaria Pisana
Pisa
Institute of Ophtalmology, Policlinico A: Gemelli (University Hospital),Catholic University of Sacred Heart
Rome, 00168
Ospedale di Circolo di Varese, Insubria University
Varese, 21100
Belgium3 sites
ZNA OCMW Antwerpen
Antwerp, 2020
University Hospital of Ghent
Ghent, B-9000
University Hospital Leuven
Leuven
Spain3 sites
Institut de Microcirurgia Ocular de Barcelona
Barcelona, 08022
Hospital Vall D'Hebron
Barcelona, 08035
Instituto Technologico de Oftalmologia SL.
Santiago de Compostela
Netherlands2 sites
Academic Hospital Groningen
Groningen, 9700 RB
Het Oogziekenhuis Rotterdam
Rotterdam, 3011 BH
United Kingdom2 sites
Royal Liverpool & Broadgreen Hospital
Liverpool, L7 8XP
Moorfields Eye Hospital
London, EC1V 2PD
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 DME.
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.
- Conditions
- Diabetic Macular Edema
- Being tested
- ocriplasmin, Sham injection
- Keywords
- Diabetic Macular Edema, PVD, DME, Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
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, single administration
Sham injectionOther
Sham intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Ocriplasmin 25µg | Experimental | 25µg ocriplasmin intravitreal injection versus sham injection Receives: Drug: ocriplasmin |
| Ocriplasmin 75µg | Experimental | 75µg ocriplasmin intravitreal injection versus sham injection Receives: Drug: ocriplasmin |
| Ocriplasmin 125µg | Experimental | 125µg ocriplasmin intravitreal injection versus sham injection Receives: Drug: ocriplasmin |
| sham injection | Sham comparator | Sham injection Receives: Other: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PVD Induction
The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT)
Measured: Day 14 post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionJan 2010
- Study completionMar 2010
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 Diabetic Macular EdemaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412451
- Sponsor's protocol ID
- TG-MV-002
- Acronym
- MIVI-II
- Status last verified
- Apr 2014
- First submitted
- 14 Dec 2006
- 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 DME.
- ClinicalTrials.gov ID
- NCT00412451
- Acronym / sponsor ID
- MIVI-II / TG-MV-002
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, PVD, DME, Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 18 Dec 2006 (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 DME.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ocriplasmin 25µg | Experimental | Drug: ocriplasmin25µg ocriplasmin intravitreal injection versus sham injection |
| Ocriplasmin 75µg | Experimental | Drug: ocriplasmin75µg ocriplasmin intravitreal injection versus sham injection |
| Ocriplasmin 125µg | Experimental | Drug: ocriplasmin125µg ocriplasmin intravitreal injection versus sham injection |
| sham injection | Sham comparator | Other: Sham injectionSham 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 Diabetic Macular Edema
Key exclusion criteria (4 listed)
- PVD present at baseline
- Vitreous hemorrhage
- Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
- 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, single administration | Drug | Ocriplasmin 125µg, Ocriplasmin 25µg, Ocriplasmin 75µg |
| Sham injectionSham intravitreal injection | Other | sham injection |
Primary outcome
PVD Induction
Time frame: Day 14 post-injection
The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT)
Results and safety
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.
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A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
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Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
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A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy
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.
15 sites in 6 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 Diabetic Macular Edema, run by ThromboGenics at 15 sites in 6 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 15 sites in Italy, Belgium, Spain, Netherlands, United Kingdom and 1 more country. 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?
PVD Induction (time frame: Day 14 post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 30 Oct 2026.