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Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy

Primary Purpose

Vitreomacular Traction Maculopathy, Eye Diseases

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Microplasmin
Sponsored by
ThromboGenics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitreomacular Traction Maculopathy focused on measuring diabetic macular edema, macular hole, vitreomacular traction syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Evidence of fibrocellular proliferation characterized by whitish epimacular tissue (surface wrinkling is not an exclusion criterion). 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%. Patients with hypertension (either systolic blood pressure [SBP] > 170 or diastolic blood pressure [DBP] > 100 mm Hg). Patients with a life-expectancy less than 6 months. Patients who have previously participated in this trial.

Sites / Locations

  • University Hospital Gasthuisberg
  • Academic Medical Center, University of Amsterdam
  • Oogziekenhuis Rotterdam

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

6

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The occurrence of any (serious) adverse event

Full Information

First Posted
July 21, 2005
Last Updated
April 4, 2014
Sponsor
ThromboGenics
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1. Study Identification

Unique Protocol Identification Number
NCT00123279
Brief Title
Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy
Official Title
A Dose-escalation Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy for Vitreomacular Traction Maculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ThromboGenics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Study drug will be administered in the mid-vitreous by injection. Patients will be enrolled into the cohorts in a sequential dose/time-escalating fashion. To ensure that enrolment is evenly balanced across eligible conditions, enrolment of any specific underlying disease type into any cohort will be capped at five (5) patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreomacular Traction Maculopathy, Eye Diseases
Keywords
diabetic macular edema, macular hole, vitreomacular traction syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Experimental
Arm Title
6
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Microplasmin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Grade of Posterior Vitreous Detachment (PVD) preoperatively and release of vitreomacular traction
Time Frame
Baseline, 1,2 and 3hr, 1, 3, 14, 28, 90 and 180 Days
Secondary Outcome Measure Information:
Title
The occurrence of any (serious) adverse event
Time Frame
Throught-out the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Evidence of fibrocellular proliferation characterized by whitish epimacular tissue (surface wrinkling is not an exclusion criterion). 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%. Patients with hypertension (either systolic blood pressure [SBP] > 170 or diastolic blood pressure [DBP] > 100 mm Hg). Patients with a life-expectancy less than 6 months. Patients who have previously participated in this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc deSmet, Prof. Dr
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Academic Medical Center, University of Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Oogziekenhuis Rotterdam
City
Rotterdam
ZIP/Postal Code
3011 BH
Country
Netherlands

12. IPD Sharing Statement

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Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy

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