Recruiting
Phase 2

Intravitreal Microplasmin

Sponsor:

UCLA

Code:

NCT00996684

Conditions

Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Microplasmin

Placebo control

Study Details

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)

Conditions

Macular Degeneration

Study ID

NCT00996684

Start date

Oct, 2009

Status verified date

Sep, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Sep, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: microplasmin, intravitreal injection

Subjects will receive one intravitreal injection of microplasmin on Day 0.

placebo comparator: Placebo

Subjects will receive one intravitreal injection of the placebo on Day 0.

Interventions

Microplasmin

Microplasmin, 1.875 mg, will be given by intravitreal injection,on Day 0.

Placebo control

The placebo control will be the microplasmin vehicle without the microplasmin.

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 ]

Central Contacts and Locations

Central contacts

Rosaleen M Ostrick, MPH, MA

310-794-5595ostrick@jsei.ucla.edu

Logan Hitchcock, B.S.

310-794-5596hitchcock@jsei.ucla.edu

Locations

Jules Stein Eye Institute/UCLA

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Steven D Schwartz, M.D.

More Information

Sponsor

University of California, Los Angeles

Last update posted

Sep 27, 2011

Last verified

Sep, 2011

Keywords

  • Wet age related macular degeneration (AMD)
  • Wet AMD
  • Vitreomacular adhesion (VMA)
  • Vitreomacular traction (VMT)
  • Neovascular age related macular degeneration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2011-09-27.