Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion

Exudative Age-Related Macular Degeneration Clinical Trial

— MIVI-5  

Official title:

A Randomized, Sham-Injection Controlled, Double-Masked, Multicenter Trial of Ocriplasmin Intravitreal Injection for Treatment of Focal Vitreomacular Adhesion in Subjects With Exudative Age-Related Macular Degeneration (AMD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913744
• Other study ID #: TG-MV-005
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2009
• Last updated: December 2, 2014
• Start date: January 2010
• Est. completion date: April 2013

Study information

• Verified date: April 2014
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicinal Products and Health ProductsItaly: The Italian Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Male or female subjects aged > 50

2. Presence of focal vitreomacular adhesion measured by Optical Coherence Tomography (OCT).

3. Diagnosis of active primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component.

4. The total area of Choroidal Neovascularization (CNV) (including both classic and occult components) encompassed within the lesion must be > 50% of the total lesion area

5. The total lesion area must be < 12 disc areas

6. Subjects who have previously received at least three antiangiogenic injections(Lucentis® or Avastin®) in the study eye.

7. Subjects with visual acuity of 20/32 to 20/200 in the study eye

8. Written informed consent obtained from the subject prior to inclusion in the study

Exclusion Criteria:

1. Evidence of complete macular Posterior Vitreous Detachment (PVD) in the study eye on biomicroscopy, B-scan ultrasound or OCT prior to planned study drug injection

2. Subjects with vitreous haemorrhage 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 angiography in the study eye or other opacities precluding visualisation of the fundus.

3. Subjects who have previously received more than 9 antiangiogenic agent injections (whether Lucentis® or Avastin® or other anti-angiogenic agent) in the study eye

4. Subjects with history of rhegmatogenous retinal detachment or proliferative vitreoretinopathy (PVR) in the study eye

5. Subjects with high myopia (> 8D) or aphakia in the study eye

6. Subjects who have had ocular surgery in the study eye in the prior three months

7. Subjects 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

• Exudative Age-Related Macular Degeneration
• Focal Vitreomacular Adhesion
• Macular Degeneration
• Tissue Adhesions
• Wet Macular Degeneration

Intervention

Drug:
• Ocriplasmin
ocriplasmin intravitreal injection (125 µg)
• Sham injection
Sham injection

Locations

Country	Name	City	State
Belgium	U.Z. Leuven St. Rafaël Hospital	Leuven
France	Rabelais Ophthalmologic Center	Lyon
France	Centre Paradis-Monticelli	Marseilles
France	Centre Ophtalmologique d'Imagerie et de Laser	Paris
France	Centre Ophtalmologique de L'Odeon	Paris
Germany	Universität Bonn Augenklinik	Bonn
Germany	Universität Lübeck Universitätsklinikum Schleswig-Holstein	Lübeck
Germany	Klinik für Augenheilkunde, Universitätsklinikum Gießen, Standort Marburg	Marburg
Germany	Augenklinik der Ludwig Maximilians Universität München	München
Italy	University of Milan Department of Clinical Science "Luigi Sacco"	Milan
Italy	Largo Agostino Gemelli (University Hospital) Institute of Ophthalmology	Rome
United Kingdom	Frimley Park Hospital	Frimley	Camberley
United Kingdom	Royal Liverpool & Broadgreen Hospital	Liverpool
United Kingdom	Moorfields Eye Hospital	London
United Kingdom	Wolverhampton Eye Infirmary New Cross Hospital	Wolverhampton
United States	Southeast Retina Center, PC	Augusta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Retinal Consultants of Houston,	Houston,	Texas
United States	Southeastern Retina Associates	Kingsport	Tennessee
United States	Valley Retina Institute	McAllen	Texas
United States	VitreoRetinal Surgery, PA	Minneapolis	Minnesota
United States	Retina-Vitreous Center, PA	New Brunswick	New Jersey
United States	Allegheny Ophthalmic & Orbital Associates, PC	Pittsburgh	Pennsylvania
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Retinal Consultants Medical Group	Sacramento	California
United States	Center for Retina and Maculla Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28	The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation	Day 28	No