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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of California, Los Angeles.
Recruitment status was  Recruiting
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

October 15, 2009
September 26, 2011
October 2009
September 2011   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00996684 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Intravitreal Microplasmin in Relieving Vitreo-Macular Adhesion in Neovascular Age-related Macular Degeneration
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)

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Macular Degeneration
  • Drug: Microplasmin
    Microplasmin, 1.875 mg, will be given by intravitreal injection,on Day 0.
  • Drug: Placebo control
    The placebo control will be the microplasmin vehicle without the microplasmin.
  • Experimental: microplasmin, intravitreal injection
    Subjects will receive one intravitreal injection of microplasmin on Day 0.
    Intervention: Drug: Microplasmin
  • Placebo Comparator: Placebo
    Subjects will receive one intravitreal injection of the placebo on Day 0.
    Intervention: Drug: Placebo control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
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
United States
 
NCT00996684
JSEI-TG-AMD-001
Yes
Steven Schwartz, University of California, Los Angeles
University of California, Los Angeles
ThromboGenics
Principal Investigator: Steven D Schwartz, M.D. University of California, Los Angeles
University of California, Los Angeles
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP