Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00435539
Other study ID # TG-MV-004
Secondary ID MIVI-IIT
Status Completed
Phase Phase 2
First received February 14, 2007
Last updated December 2, 2014
Start date February 2007
Est. completion date February 2009

Study information

Verified date April 2014
Source ThromboGenics
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHPGermany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
ocriplasmin
Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.
ocriplasmin
Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.
Sham Comparator
Intravitreal sham injection

Locations

Country Name City State
Belgium ZNA OCMW Antwerpen Antwerpen
Belgium University Hospital of Ghent Ghent
Belgium Universitaire Ziekenhuizen K.U.Leuven Leuven
Germany Augenklinik der Universitat Munchen Munchen

Sponsors (1)

Lead Sponsor Collaborator
ThromboGenics

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day 14 No
Secondary Resolution of Vitreomacular Traction (Investigator's Assessment) 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. Day 28 No
See also
  Status Clinical Trial Phase
Completed NCT06038968 - Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy Early Phase 1
Terminated NCT04300881 - Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists) Phase 2
Active, not recruiting NCT01966328 - A Safety and Efficacy Assessment of Resolvine for Treatment of Vitreomacular Attachment Phase 1
Completed NCT03647267 - Effects of Pneumatic Vitreolysis on Vitreomacular Traction Phase 3
Recruiting NCT02290795 - Vitreopapillary Interface and Optic Disc Morphology N/A
Completed NCT05287269 - Ocular Coherence Tomography During Cataract Assessment
Completed NCT02322229 - Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion Phase 4
Completed NCT05517473 - Efficacy and Safety Evaluation of MONOBLUE DUAL View and MONOBLUE ILM View Vital Stains
Completed NCT01162356 - Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) Study N/A
Recruiting NCT05588037 - Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery N/A
Recruiting NCT00892619 - Comparison of Two Techniques for Epiretinal or Internal Limiting Membrane Peel N/A
Completed NCT02035748 - Assessment of Patients Treated With JETREA® for Vitreomacular Traction Phase 4
Recruiting NCT05860985 - Zeiss RESIGHT Disposable Lenses Evaluation Study N/A