Macular DegenerationPhase 2AMDNCT00996684
Study of Intravitreal Microplasmin in Relieving Vitreo-Macular Adhesion in Neovascular Age-related Macular Degeneration
A Phase 2 study testing Microplasmin in people with Macular Degeneration, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to determine whether microplasmin given by intravitreal injection is effective and safe for the treatment of wet age-related macular degeneration (AMD) in patients who have focal vitreomacular adhesion (VMA) Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Microplasmin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2011
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 50 years or older
- Presence of focal vitreomacular adhesion as seen by OCT
- BCVA of 20/800 or better in non-study eye
- Presence of active choroidal neovascular membrane
- Written informed consent obtained from subject prior to inclusion in the trial
Who cannot join
- Subjects who have previously received microplasmin
- Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes adequate examination or investigation of study eye
- Patient with uncontrolled glaucoma including IOP >25 mm Hg
- Subjects who have had vitrectomy or retinal detachment or who are aphakic or highly myopic (>8.0 D) in the study eye
- Subjects who are pregnant or of child-bearing potential not utilizing an acceptable form of contraception. Acceptable methods include intrauterine device, oral, implanted or injected contraceptives, and barrier methods with spermicide.
- Subjects who, in the Investigator's view, will not complete all visits and investigations
- Patient who have PDT or any intravitreal injection in the last 10 days. Patients who in the examiners opinion will need intravitreal injection in the next 10 days (apart from microplasmin).
- Patients who have participated in an investigational drug trial in the past 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Jules Stein Eye Institute/UCLA
Los Angeles, California, 90095
Steven D Schwartz, M.D.
Jean-Pierre Hubschman, M.D.
About this study
Official title: Resolution of Vitreomacular Adhesion (VMA) Associated With Neovascular Age Related Macular Degeneration (AMD) With Intravitreal Microplasmin
The purpose of this study is to determine whether microplasmin given by intravitreal injection is effective and safe for the treatment of wet age-related macular degeneration (AMD) in patients who have focal vitreomacular adhesion (VMA)
Read the detailed description
The human vitreous gel undergoes progressive liquefaction with age. Concurrent with the process of vitreous liquefaction, there is a weakening of the adhesion at the vitreoretinal interface between the cortical vitreous gel and the inner limiting lamina. Posterior vitreous detachment (PVD) is a separation of the cortical vitreous get from the inner limiting lamina. PVD is usually a sudden event during which liquefied vitreous from the center of the vitreous body bursts through a hole in the posterior vitreous cortex and then dissects the residual cortex gel away from the inner limiting lamina. If there is residual vitreoretinal traction around the break, this process may induce a tear in the retina that can in turn result in rhegmatogenous retinal detachment, macular hole, or cystoid macular edema. The importance of the vitreous in the progression of diabetic retinopathy may also extend beyond tractional considerations. For example, it is believed that the vitreous serves as scaffolding for new vessel formation and may also contribute to molecular imbalances that lead to retinopathy progression. Therefore, total PVD, by releasing vitreoretinal traction as well as other potential mechanisms, may be beneficial in various vitreoretinal diseases such as neovascular AMD.
Vitreomacular adhesion (VMA) in exudative (wet) AMD may be associated with poor prognosis in patients with AMD. This trial is primarily aimed at showing that release of VMA can be induced by microplasmin, a proteolytic enzyme, in patients with wet AMD, and that microplasmin is safe in patients w/ neovascular (wet) AMD. Secondary endpoint will be assessment of improved AMD outcomes.
- Conditions
- Macular Degeneration
- Being tested
- Microplasmin, Placebo control
- Keywords
- Wet age related macular degeneration (AMD), Wet AMD, Vitreomacular adhesion (VMA), Vitreomacular traction (VMT), Neovascular age related macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroplasminDrug
Microplasmin, 1.875 mg, will be given by intravitreal injection,on Day 0.
Placebo controlDrug
The placebo control will be the microplasmin vehicle without the microplasmin.
| Study group | Role | What they receive |
|---|---|---|
| microplasmin, intravitreal injection | Experimental | Subjects will receive one intravitreal injection of microplasmin on Day 0. Receives: Drug: Microplasmin |
| Placebo | Placebo comparator | Subjects will receive one intravitreal injection of the placebo on Day 0. Receives: Drug: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the proportion of patients in whom there is release of vitreomacular traction as assessed by ultrasonography, optical coherence tomography and physical examination
Measured: Day 28
Secondary outcomes (5)
Total number of ranibizumab injections following microplasmin in those with PVD compared with those without PVD
Measured: 12 months
Change in mean macular thickness
Measured: Day 28 and month 12
Mean change in ETDRS visual acuity
Measured: Day 28 and Month 12
Incidence and severity of ocular adverse events
Measured: Day 28 and Month 12
Incidence and severity of nonocular adverse events
Measured: Day 28 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- ThromboGenics
- Responsible party
- Principal investigator, Steven Schwartz, University of California, Los Angeles
- Investigators
- Steven D Schwartz, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996684
- Sponsor's protocol ID
- JSEI-TG-AMD-001
- Acronym
- AMD
- Status last verified
- Sep 2011
- First submitted
- 15 Oct 2009
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resolution of Vitreomacular Adhesion (VMA) Associated With Neovascular Age Related Macular Degeneration (AMD) With Intravitreal Microplasmin
- ClinicalTrials.gov ID
- NCT00996684
- Acronym / sponsor ID
- AMD / JSEI-TG-AMD-001
- Conditions
- Macular Degeneration
- Keywords
- Wet age related macular degeneration (AMD), Wet AMD, Vitreomacular adhesion (VMA), Vitreomacular traction (VMT), Neovascular age related macular degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- ThromboGenics
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 16 Oct 2009 (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 study is to determine whether microplasmin given by intravitreal injection is effective and safe for the treatment of wet age-related macular degeneration (AMD) in patients who have focal vitreomacular adhesion (VMA)
Detailed description
The human vitreous gel undergoes progressive liquefaction with age. Concurrent with the process of vitreous liquefaction, there is a weakening of the adhesion at the vitreoretinal interface between the cortical vitreous gel and the inner limiting lamina. Posterior vitreous detachment (PVD) is a separation of the cortical vitreous get from the inner limiting lamina. PVD is usually a sudden event during which liquefied vitreous from the center of the vitreous body bursts through a hole in the posterior vitreous cortex and then dissects the residual cortex gel away from the inner limiting lamina. If there is residual vitreoretinal traction around the break, this process may induce a tear in the retina that can in turn result in rhegmatogenous retinal detachment, macular hole, or cystoid macular edema. The importance of the vitreous in the progression of diabetic retinopathy may also extend beyond tractional considerations. For example, it is believed that the vitreous serves as scaffolding for new vessel formation and may also contribute to molecular imbalances that lead to retinopathy progression. Therefore, total PVD, by releasing vitreoretinal traction as well as other potential mechanisms, may be beneficial in various vitreoretinal diseases such as neovascular AMD.
Vitreomacular adhesion (VMA) in exudative (wet) AMD may be associated with poor prognosis in patients with AMD. This trial is primarily aimed at showing that release of VMA can be induced by microplasmin, a proteolytic enzyme, in patients with wet AMD, and that microplasmin is safe in patients w/ neovascular (wet) AMD. Secondary endpoint will be assessment of improved AMD outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microplasmin, intravitreal injection | Experimental | Drug: MicroplasminSubjects will receive one intravitreal injection of microplasmin on Day 0. |
| Placebo | Placebo comparator | Drug: Placebo controlSubjects will receive one intravitreal injection of the placebo on Day 0. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects aged 50 years or older
- Presence of focal vitreomacular adhesion as seen by OCT
- BCVA of 20/800 or better in non-study eye
- Presence of active choroidal neovascular membrane
- Written informed consent obtained from subject prior to inclusion in the trial
Key exclusion criteria (8 listed)
- Subjects who have previously received microplasmin
- Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes adequate examination or investigation of study eye
- Patient with uncontrolled glaucoma including IOP >25 mm Hg
- Subjects who have had vitrectomy or retinal detachment or who are aphakic or highly myopic (>8.0 D) in the study eye
- Subjects who are pregnant or of child-bearing potential not utilizing an acceptable form of contraception. Acceptable methods include intrauterine device, oral, implanted or injected contraceptives, and barrier methods with spermicide.
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 |
|---|---|---|
| MicroplasminMicroplasmin, 1.875 mg, will be given by intravitreal injection,on Day 0. | Drug | microplasmin, intravitreal injection |
| Placebo controlThe placebo control will be the microplasmin vehicle without the microplasmin. | Drug | Placebo |
Primary outcome
The primary outcome is the proportion of patients in whom there is release of vitreomacular traction as assessed by ultrasonography, optical coherence tomography and physical examination
Time frame: Day 28
5 secondary outcomes
Total number of ranibizumab injections following microplasmin in those with PVD compared with those without PVD
Time frame: 12 months
Change in mean macular thickness
Time frame: Day 28 and month 12
Mean change in ETDRS visual acuity
Time frame: Day 28 and Month 12
Incidence and severity of ocular adverse events
Time frame: Day 28 and Month 12
Incidence and severity of nonocular adverse events
Time frame: Day 28 and Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
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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.
Steven D Schwartz, M.D. principal investigator
University of California, Los Angeles
1 site in 1 country: 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 Macular Degeneration, run by University of California, Los Angeles at 1 site in United States.
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 8 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: status not confirmed, as of the sponsor's last update on 27 Sep 2011. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosaleen M Ostrick, MPH, MA (310-794-5595, ostrick@jsei.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the proportion of patients in whom there is release of vitreomacular traction as assessed by ultrasonography, optical coherence tomography and physical examination (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 27 Sep 2011; AzTrials last refreshed its copy on 7 Nov 2026.