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Study of Intravitreal Microplasmin in Relieving Vitreo-Macular Adhesion in Neovascular Age-related Macular Degeneration (AMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00996684
Recruitment Status : Unknown
Verified September 2011 by Steven Schwartz, University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : October 16, 2009
Last Update Posted : September 27, 2011
Information provided by (Responsible Party):
Steven Schwartz, University of California, Los Angeles

Brief 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)

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: Microplasmin Drug: Placebo control Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Resolution of Vitreomacular Adhesion (VMA) Associated With Neovascular Age Related Macular Degeneration (AMD) With Intravitreal Microplasmin
Study Start Date : October 2009
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ocriplasmin

Arm Intervention/treatment
Experimental: microplasmin, intravitreal injection
Subjects will receive one intravitreal injection of microplasmin on Day 0.
Drug: Microplasmin
Microplasmin, 1.875 mg, will be given by intravitreal injection,on Day 0.

Placebo Comparator: Placebo
Subjects will receive one intravitreal injection of the placebo on Day 0.
Drug: Placebo control
The placebo control will be the microplasmin vehicle without the microplasmin.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Total number of ranibizumab injections following microplasmin in those with PVD compared with those without PVD [ Time Frame: 12 months ]
  2. Change in mean macular thickness [ Time Frame: Day 28 and month 12 ]
  3. Mean change in ETDRS visual acuity [ Time Frame: Day 28 and Month 12 ]
  4. Incidence and severity of ocular adverse events [ Time Frame: Day 28 and Month 12 ]
  5. Incidence and severity of nonocular adverse events [ Time Frame: Day 28 and Month 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00996684

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Contact: Rosaleen M Ostrick, MPH, MA 310-794-5595
Contact: Logan Hitchcock, B.S. 310-794-5596

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United States, California
Jules Stein Eye Institute/UCLA Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Steven D Schwartz, M.D.         
Sub-Investigator: Jean-Pierre Hubschman, M.D.         
Sponsors and Collaborators
University of California, Los Angeles
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Principal Investigator: Steven D Schwartz, M.D. University of California, Los Angeles
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Responsible Party: Steven Schwartz, Chief, Retina Division, University of California, Los Angeles Identifier: NCT00996684    
Other Study ID Numbers: JSEI-TG-AMD-001
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: September 27, 2011
Last Verified: September 2011
Keywords provided by Steven Schwartz, University of California, Los Angeles:
Wet age related macular degeneration (AMD)
Vitreomacular adhesion (VMA)
Vitreomacular traction (VMT)
Neovascular age related macular degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Tissue Adhesions
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathologic Processes
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action