Exudative Age-Related Macular DegenerationPhase 2MIVI-5NCT00913744
Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion
A Phase 2 study testing Ocriplasmin in people with Exudative Age-Related Macular Degeneration and Focal Vitreomacular Adhesion, run by ThromboGenics at 27 sites in 6 countries.
Trial summary
This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Exudative Age-Related Macular Degeneration, Focal 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
- 100 participants
- Where
- 27 sitesin 6 countries
- Study dates
- Jan 2010to Apr 2013
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged > 50
- Presence of focal vitreomacular adhesion measured by Optical Coherence Tomography (OCT).
- Diagnosis of active primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component.
- The total area of Choroidal Neovascularization (CNV) (including both classic and occult components) encompassed within the lesion must be > 50% of the total lesion area
- The total lesion area must be < 12 disc areas
- Subjects who have previously received at least three antiangiogenic injections(Lucentis® or Avastin®) in the study eye.
- Subjects with visual acuity of 20/32 to 20/200 in the study eye
- Written informed consent obtained from the subject prior to inclusion in the study
Who cannot join
- Evidence of complete macular Posterior Vitreous Detachment (PVD) in the study eye on biomicroscopy, B-scan ultrasound or OCT prior to planned study drug injection
- Subjects with vitreous haemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection or adequate assessment of the macula by either OCT and/or fluorescein angiography in the study eye or other opacities precluding visualisation of the fundus.
- Subjects who have previously received more than 9 antiangiogenic agent injections (whether Lucentis® or Avastin® or other anti-angiogenic agent) in the study eye
- Subjects with history of rhegmatogenous retinal detachment or proliferative vitreoretinopathy (PVR) in the study eye
- Subjects with high myopia (> 8D) or aphakia in the study eye
- Subjects who have had ocular surgery in the study eye in the prior three months
- Subjects who have had a vitrectomy in the study eye at any time.
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
United States12 sites
Southeast Retina Center, PC
Augusta, Georgia, 30909
University of Colorado Denver
Aurora, Colorado, 80045
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Retinal Consultants of Houston,
Houston, Texas, 78730
Southeastern Retina Associates
Kingsport, Tennessee, 37660
Valley Retina Institute
McAllen, Texas, 78503
VitreoRetinal Surgery, PA
Minneapolis, Minnesota, 55435
Retina-Vitreous Center, PA
New Brunswick, New Jersey, 08901
Allegheny Ophthalmic & Orbital Associates, PC
Pittsburgh, Pennsylvania, 15212
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Retinal Consultants Medical Group
Sacramento, California, 95819
Center for Retina and Maculla Disease
Winter Haven, Florida, 33880
France4 sites
Rabelais Ophthalmologic Center
Lyon, F-69003
Centre Paradis-Monticelli
Marseille, F-13008
Centre Ophtalmologique d'Imagerie et de Laser
Paris, 75015
Centre Ophtalmologique de L'Odeon
Paris, F75006
Germany4 sites
Universität Bonn Augenklinik
Bonn, D-53127
Universität Lübeck Universitätsklinikum Schleswig-Holstein
Lübeck, D-23538
Klinik für Augenheilkunde, Universitätsklinikum Gießen, Standort Marburg
Marburg, D-35043
Augenklinik der Ludwig Maximilians Universität München
München, 80336
United Kingdom4 sites
Frimley Park Hospital
Frimley, Camberley, GU16 7UJ
Royal Liverpool & Broadgreen Hospital
Liverpool, L7 8XP
Moorfields Eye Hospital
London, EC1V 2PD
Wolverhampton Eye Infirmary New Cross Hospital
Wolverhampton, WV10 0QP
Italy2 sites
University of Milan Department of Clinical Science "Luigi Sacco"
Milan
Largo Agostino Gemelli (University Hospital) Institute of Ophthalmology
Rome, I-00168
About this study
Official title: A Randomized, Sham-Injection Controlled, Double-Masked, Multicenter Trial of Ocriplasmin Intravitreal Injection for Treatment of Focal Vitreomacular Adhesion in Subjects With Exudative Age-Related Macular Degeneration (AMD)
This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).
- Being tested
- Ocriplasmin, Sham injection
- Keywords
- AMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcriplasminDrug
ocriplasmin intravitreal injection (125 µg)
Sham injectionDrug
Sham injection
| Study group | Role | What they receive |
|---|---|---|
| Ocriplasmin | Experimental | Not described Receives: Drug: Ocriplasmin |
| Sham injection | Sham comparator | Not described 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 Focal Vitreomacular Adhesion (VMA) Release by Day 28
The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionApr 2013
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 Exudative Age-Related Macular DegenerationStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913744
- Sponsor's protocol ID
- TG-MV-005
- Acronym
- MIVI-5
- Status last verified
- Apr 2014
- First submitted
- 2 Jun 2009
- 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, Multicenter Trial of Ocriplasmin Intravitreal Injection for Treatment of Focal Vitreomacular Adhesion in Subjects With Exudative Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT00913744
- Acronym / sponsor ID
- MIVI-5 / TG-MV-005
- Keywords
- AMD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Posted 5 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).
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: Ocriplasmin |
| Sham injection | Sham comparator | Drug: Sham injection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects aged > 50
- Presence of focal vitreomacular adhesion measured by Optical Coherence Tomography (OCT).
- Diagnosis of active primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component.
- The total area of Choroidal Neovascularization (CNV) (including both classic and occult components) encompassed within the lesion must be > 50% of the total lesion area
- The total lesion area must be < 12 disc areas
Key exclusion criteria (7 listed)
- Evidence of complete macular Posterior Vitreous Detachment (PVD) in the study eye on biomicroscopy, B-scan ultrasound or OCT prior to planned study drug injection
- Subjects with vitreous haemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection or adequate assessment of the macula by either OCT and/or fluorescein angiography in the study eye or other opacities precluding visualisation of the fundus.
- Subjects who have previously received more than 9 antiangiogenic agent injections (whether Lucentis® or Avastin® or other anti-angiogenic agent) in the study eye
- Subjects with history of rhegmatogenous retinal detachment or proliferative vitreoretinopathy (PVR) in the study eye
- Subjects with high myopia (> 8D) or 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 |
|---|---|---|
| Ocriplasminocriplasmin intravitreal injection (125 µg) | Drug | Ocriplasmin |
| Sham injectionSham injection | Drug | Sham injection |
Primary outcome
Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28
Time frame: Day 28
The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation
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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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.
27 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 Exudative Age-Related Macular Degeneration and Focal Vitreomacular Adhesion, run by ThromboGenics at 27 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 8 inclusion and 7 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 27 sites in United States, France, Germany, United Kingdom, Italy 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 5 May 2014). 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 Focal Vitreomacular Adhesion (VMA) Release by 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?
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.