Vitreomacular Traction MaculopathyPhase 2NCT00123279
Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy
A Phase 2 study testing Microplasmin in people with Vitreomacular Traction Maculopathy and Eye Diseases, run by ThromboGenics at 3 sites in 2 countries.
Trial summary
The purpose of this trial is to evaluate the safety and preliminary efficacy of different doses and several exposure times of intravitreal microplasmin in the setting of pars plana vitrectomy for vitreomacular traction maculopathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vitreomacular Traction Maculopathy, Eye Diseases
- What is being tested?
- Microplasmin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2004to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with vitreomacular traction maculopathy for whom vitrectomy is indicated, according to the principal investigator, including:
- Macular edema associated with vitreomacular traction (DME, VMTS);
- Stage II-III macular hole of < 6 months duration since symptom onset;
- Demonstration of vitreomacular adhesion (based on preoperative optic coherence tomography [OCT]) in the study eye;
- OCT - presence of posterior hyaloid membrane inserting on to the macula, but with some area of clear separation visible between the retina and the posterior hyaloid.
Who cannot join
- Evidence of fibrocellular proliferation characterized by whitish epimacular tissue (surface wrinkling is not an exclusion criterion).
- Patients with vitreous hemorrhage 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 angiogram in the study eye.
- Patients with rhegmatogenous retinal detachment, proliferative vitreoretinopathy (PVR), or retinal degenerative changes in the study eye.
- Patients with high myopia or aphakia in the study eye
- Patients with history of rhegmatogenous retinal detachment in the fellow eye or family history of retinal detachment
- Patients who are considered likely to require intraocular surgery in the study eye for any reason other than vitreomacular traction maculopathy/macular edema in the coming three months.
Show all 19Show fewer
- Patients who have had ocular surgery in the study eye in the prior three months.
- Patients who have had a vitrectomy in the study eye at any time.
- Patients with a history of uveitis or significant trauma in the study eye.
- Patients who are currently being treated for glaucoma in the study eye.
- Patients who have had laser photocoagulation treatment in the study eye in the previous 3 months.
- Intravitreal injection of any drug in the study eye in the previous 6 months or during the study.
- Patients who are pregnant or of child-bearing potential not utilizing a form of contraception acceptable to the investigator.
- Patients who, in the investigator's view, will not complete all visits and investigations, including the exit visit at 6 months.
- Patients who have participated in an investigational drug study within the past 30 days.
- HgA1c > 9%.
- Patients with hypertension (either systolic blood pressure [SBP] > 170 or diastolic blood pressure [DBP] > 100 mm Hg).
- Patients with a life-expectancy less than 6 months.
- Patients who have previously participated in this trial.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Netherlands2 sites
Academic Medical Center, University of Amsterdam
Amsterdam, 1105 AZ
Oogziekenhuis Rotterdam
Rotterdam, 3011 BH
About this study
Official title: A Dose-escalation Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy for Vitreomacular Traction Maculopathy
The purpose of this trial is to evaluate the safety and preliminary efficacy of different doses and several exposure times of intravitreal microplasmin in the setting of pars plana vitrectomy for vitreomacular traction maculopathy.
Read the detailed description
Study drug will be administered in the mid-vitreous by injection. Patients will be enrolled into the cohorts in a sequential dose/time-escalating fashion. To ensure that enrolment is evenly balanced across eligible conditions, enrolment of any specific underlying disease type into any cohort will be capped at five (5) patients.
- Conditions
- Vitreomacular Traction Maculopathy, Eye Diseases
- Being tested
- Microplasmin
- Keywords
- diabetic macular edema, macular hole, vitreomacular traction syndrome
- Medical subject headings
- Eye Diseases, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroplasminDrug
25ug injected 1 hr prior to PPV, 24 hr and 7 days prior to PPV, 50ug injected 24 hr prior to PPV, 75ug injected 24 hr prior to PPV and 125ug injected 24 hr prior to PPV.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Microplasmin |
| 2 | Experimental | Not described Receives: Drug: Microplasmin |
| 3 | Experimental | Not described Receives: Drug: Microplasmin |
| 4 | Experimental | Not described Receives: Drug: Microplasmin |
| 5 | Experimental | Not described Receives: Drug: Microplasmin |
| 6 | Experimental | Not described Receives: Drug: Microplasmin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of Posterior Vitreous Detachment (PVD) preoperatively and release of vitreomacular traction
Measured: Baseline, 1,2 and 3hr, 1, 3, 14, 28, 90 and 180 Days
Secondary outcomes (1)
The occurrence of any (serious) adverse event
Measured: Throught-out the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startDec 2004
- Primary completionFeb 2007
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreomacular Traction MaculopathyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marc deSmet, Prof. Dr, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123279
- Sponsor's protocol ID
- TG-MV-001
- Status last verified
- Apr 2014
- First submitted
- 21 Jul 2005
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-escalation Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy for Vitreomacular Traction Maculopathy
- ClinicalTrials.gov ID
- NCT00123279
- Acronym / sponsor ID
- TG-MV-001
- Conditions
- Vitreomacular Traction Maculopathy, Eye Diseases
- Keywords
- diabetic macular edema, macular hole, vitreomacular traction syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Feb 2007 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
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 trial is to evaluate the safety and preliminary efficacy of different doses and several exposure times of intravitreal microplasmin in the setting of pars plana vitrectomy for vitreomacular traction maculopathy.
Detailed description
Study drug will be administered in the mid-vitreous by injection. Patients will be enrolled into the cohorts in a sequential dose/time-escalating fashion. To ensure that enrolment is evenly balanced across eligible conditions, enrolment of any specific underlying disease type into any cohort will be capped at five (5) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Microplasmin |
| 2 | Experimental | Drug: Microplasmin |
| 3 | Experimental | Drug: Microplasmin |
| 4 | Experimental | Drug: Microplasmin |
| 5 | Experimental | Drug: Microplasmin |
| 6 | Experimental | Drug: Microplasmin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with vitreomacular traction maculopathy for whom vitrectomy is indicated, according to the principal investigator, including:
Key exclusion criteria (19 listed)
- Evidence of fibrocellular proliferation characterized by whitish epimacular tissue (surface wrinkling is not an exclusion criterion).
- Patients with vitreous hemorrhage 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 angiogram in the study eye.
- Patients with rhegmatogenous retinal detachment, proliferative vitreoretinopathy (PVR), or retinal degenerative changes in the study eye.
- Patients with high myopia or aphakia in the study eye
- Patients with history of rhegmatogenous retinal detachment in the fellow eye or family history of retinal detachment
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 |
|---|---|---|
| Microplasmin25ug injected 1 hr prior to PPV, 24 hr and 7 days prior to PPV, 50ug injected 24 hr prior to PPV, 75ug injected 24 hr prior to PPV and 125ug injected 24 hr prior to PPV. | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
Grade of Posterior Vitreous Detachment (PVD) preoperatively and release of vitreomacular traction
Time frame: Baseline, 1,2 and 3hr, 1, 3, 14, 28, 90 and 180 Days
1 secondary outcome
The occurrence of any (serious) adverse event
Time frame: Throught-out the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
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.
Marc deSmet, Prof. Dr principal investigator
Amsterdam UMC, location VUmc
3 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 Microplasmin in people with Vitreomacular Traction Maculopathy and Eye Diseases, run by ThromboGenics at 3 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 5 inclusion and 19 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 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Belgium. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Grade of Posterior Vitreous Detachment (PVD) preoperatively and release of vitreomacular traction (time frame: Baseline, 1,2 and 3hr, 1, 3, 14, 28, 90 and 180 Days). 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 7 Apr 2014.