A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00435539
First received: February 14, 2007
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.


Condition Intervention Phase
Vitreomacular Traction
Drug: ocriplasmin
Drug: Sham Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical Posterior Vitreous Detachment (PVD) Induction for Treatment of Vitreomacular Traction (VMT).

Resource links provided by NLM:


Further study details as provided by ThromboGenics:

Primary Outcome Measures:
  • Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Resolution of Vitreomacular Traction (Investigator's Assessment) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Resolution of VMT was evaluated by the investigator using optical coherence tomography (OCT).Resolution of VMT was defined as a change from baseline status of Yes to post-injection status of No and was evaluated by the investigator using OCT. Subjects undergoing vitrectomy had their last observation prior to vitrectomy carried forward.


Enrollment: 60
Study Start Date: February 2007
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ocriplasmin 75µg single injection
Ocriplasmin 75µg single injection versus sham injection
Drug: ocriplasmin
Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.
Other Name: microplasmin
Experimental: ocriplasmin 125µg single injection
Ocriplasmin 125µg single injection versus sham injection
Drug: ocriplasmin
Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.
Other Name: microplasmin
Experimental: ocriplasmin 175µg single injection
Ocriplasmin 175µg single injection versus sham injection
Drug: ocriplasmin
Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.
Other Name: microplasmin
Experimental: ocriplasmin 125µg multiple injections
Ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125µg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125µg.
Drug: ocriplasmin
Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.
Other Name: microplasmin
Sham Comparator: sham injection
sham injection
Drug: Sham Comparator
Intravitreal sham injection
Other Name: microplasmin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients >_ 18 years of age with vitreomacular traction

Exclusion Criteria:

  • PVD present at baseline
  • Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
  • Vitreous hemorrhage
  • Patients who have had a vitrectomy in the study eye at any time
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435539

Locations
Belgium
ZNA OCMW Antwerpen
Antwerpen, Belgium, 2020
University Hospital of Ghent
Ghent, Belgium, B-9000
Universitaire Ziekenhuizen K.U.Leuven
Leuven, Belgium
Germany
Augenklinik der Universitat Munchen
Munchen, Germany, 80336
Sponsors and Collaborators
ThromboGenics
  More Information

No publications provided

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00435539     History of Changes
Other Study ID Numbers: TG-MV-004, MIVI-IIT
Study First Received: February 14, 2007
Results First Received: July 4, 2013
Last Updated: April 4, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ThromboGenics:
Vitreomacular Traction
Maculopathy
VMT
PVD

Additional relevant MeSH terms:
Vitreous Detachment
Eye Diseases

ClinicalTrials.gov processed this record on July 20, 2014