NCT00123279

Brief Summary

The purpose of this trial is to evaluate the safety and preliminary efficacy of different doses and several exposure times of intravitreal microplasmin in the setting of pars plana vitrectomy for vitreomacular traction maculopathy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2004

Typical duration for phase_2

Geographic Reach
2 countries

3 active sites

Status
completed

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

December 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

April 7, 2014

Status Verified

April 1, 2014

Enrollment Period

2.2 years

First QC Date

July 21, 2005

Last Update Submit

April 4, 2014

Conditions

Vitreomacular Traction MaculopathyEye Diseases

Keywords

diabetic macular edemamacular holevitreomacular traction syndrome

Outcome Measures

Primary Outcomes (1)

  • Grade of Posterior Vitreous Detachment (PVD) preoperatively and release of vitreomacular traction

    Baseline, 1,2 and 3hr, 1, 3, 14, 28, 90 and 180 Days

Secondary Outcomes (1)

  • The occurrence of any (serious) adverse event

    Throught-out the study

Study Arms (6)

1

EXPERIMENTAL
Drug: Microplasmin

2

EXPERIMENTAL
Drug: Microplasmin

3

EXPERIMENTAL
Drug: Microplasmin

4

EXPERIMENTAL
Drug: Microplasmin

5

EXPERIMENTAL
Drug: Microplasmin

6

EXPERIMENTAL
Drug: Microplasmin

Interventions

MicroplasminDRUG

25ug injected 1 hr prior to PPV, 24 hr and 7 days prior to PPV, 50ug injected 24 hr prior to PPV, 75ug injected 24 hr prior to PPV and 125ug injected 24 hr prior to PPV.

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Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with vitreomacular traction maculopathy for whom vitrectomy is indicated, according to the principal investigator, including:
  • Macular edema associated with vitreomacular traction (DME, VMTS);
  • Stage II-III macular hole of \< 6 months duration since symptom onset;
  • Demonstration of vitreomacular adhesion (based on preoperative optic coherence tomography \[OCT\]) in the study eye;
  • OCT - presence of posterior hyaloid membrane inserting on to the macula, but with some area of clear separation visible between the retina and the posterior hyaloid.

You may not qualify if:

  • Patients with vitreous hemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye.
  • Patients with rhegmatogenous retinal detachment, proliferative vitreoretinopathy (PVR), or retinal degenerative changes in the study eye.
  • Patients with high myopia or aphakia in the study eye
  • Patients with history of rhegmatogenous retinal detachment in the fellow eye or family history of retinal detachment
  • Patients who are considered likely to require intraocular surgery in the study eye for any reason other than vitreomacular traction maculopathy/macular edema in the coming three months.
  • Patients who have had ocular surgery in the study eye in the prior three months.
  • Patients who have had a vitrectomy in the study eye at any time.
  • Patients with a history of uveitis or significant trauma in the study eye.
  • Patients who are currently being treated for glaucoma in the study eye.
  • Patients who have had laser photocoagulation treatment in the study eye in the previous 3 months.
  • Intravitreal injection of any drug in the study eye in the previous 6 months or during the study.
  • Patients who are pregnant or of child-bearing potential not utilizing a form of contraception acceptable to the investigator.
  • Patients who, in the investigator's view, will not complete all visits and investigations, including the exit visit at 6 months.
  • Patients who have participated in an investigational drug study within the past 30 days.
  • HgA1c \> 9%.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital Gasthuisberg

Leuven, B-3000, Belgium

Location

Academic Medical Center, University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Oogziekenhuis Rotterdam

Rotterdam, 3011 BH, Netherlands

Location

MeSH Terms

Conditions

Eye DiseasesRetinal Perforations

Interventions

microplasmin

Condition Hierarchy (Ancestors)

Retinal Diseases

Study Officials

  • Marc deSmet, Prof. Dr

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 21, 2005

First Posted

July 22, 2005

Study Start

December 1, 2004

Primary Completion

February 1, 2007

Study Completion

November 1, 2008

Last Updated

April 7, 2014

Record last verified: 2014-04

Locations

BE(1)NL(2)