NCT00996684

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

1.9 years

First QC Date

October 15, 2009

Last Update Submit

September 26, 2011

Conditions

Macular Degeneration

Keywords

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

Outcome Measures

Primary Outcomes (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

    Day 28

Secondary Outcomes (5)

  • Total number of ranibizumab injections following microplasmin in those with PVD compared with those without PVD

    12 months

  • Change in mean macular thickness

    Day 28 and month 12

  • Mean change in ETDRS visual acuity

    Day 28 and Month 12

  • Incidence and severity of ocular adverse events

    Day 28 and Month 12

  • Incidence and severity of nonocular adverse events

    Day 28 and Month 12

Study Arms (2)

microplasmin, intravitreal injection

EXPERIMENTAL

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

Drug: Microplasmin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo control

Interventions

MicroplasminDRUG

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

microplasmin, intravitreal injection
Placebo controlDRUG

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

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jules Stein Eye Institute/UCLA

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

microplasmin

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Steven D Schwartz, M.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosaleen M Ostrick, MPH, MA

CONTACT

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

Logan Hitchcock, B.S.

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Retina Division

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 16, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations

US(1)