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

This study is currently recruiting participants.
Verified September 2011 by University of California, Los Angeles
Sponsor:
Collaborator:
ThromboGenics
Information provided by (Responsible Party):
Steven Schwartz, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00996684
First received: October 15, 2009
Last updated: September 26, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Macular Degeneration
 Drug: Microplasmin
Drug: Placebo control
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Resolution of Vitreomacular Adhesion (VMA) Associated With Neovascular Age Related Macular Degeneration (AMD) With Intravitreal Microplasmin

Resource links provided by NLM:

Drug Information available for: Ocriplasmin
U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total number of ranibizumab injections following microplasmin in those with PVD compared with those without PVD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in mean macular thickness [ Time Frame: Day 28 and month 12 ] [ Designated as safety issue: No ]
  • Mean change in ETDRS visual acuity [ Time Frame: Day 28 and Month 12 ] [ Designated as safety issue: No ]
  • Incidence and severity of ocular adverse events [ Time Frame: Day 28 and Month 12 ] [ Designated as safety issue: Yes ]
  • Incidence and severity of nonocular adverse events [ Time Frame: Day 28 and Month 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996684

Contacts
Contact: Rosaleen M Ostrick, MPH, MA 310-794-5595 ostrick@jsei.ucla.edu
Contact: Logan Hitchcock, B.S. 310-794-5596 hitchcock@jsei.ucla.edu

Locations
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
ThromboGenics
Investigators
Principal Investigator: Steven D Schwartz, M.D. University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Steven Schwartz, Chief, Retina Division, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00996684     History of Changes
Other Study ID Numbers: JSEI-TG-AMD-001
Study First Received: October 15, 2009
Last Updated: September 26, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
Wet age related macular degeneration (AMD)
Wet AMD
Vitreomacular adhesion (VMA)
Vitreomacular traction (VMT)
Neovascular age related macular degeneration

Additional relevant MeSH terms:
Tissue Adhesions
Macular Degeneration
Wet Macular Degeneration
Cicatrix
Fibrosis
 Pathologic Processes
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013