Clinical trial NCT00913744: Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Exudative Age-Related Macular Degeneration
Focal Vitreomacular Adhesion
Keywords: AMD
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Winter Haven
country: United States
facility: Center for Retina and Maculla Disease
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center, PC
state: Georgia
city: Minneapolis
country: United States
facility: VitreoRetinal Surgery, PA
state: Minnesota
city: New Brunswick
country: United States
facility: Retina-Vitreous Center, PA
state: New Jersey
city: Pittsburgh
country: United States
facility: Allegheny Ophthalmic & Orbital Associates, PC
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Kingsport
country: United States
facility: Southeastern Retina Associates
state: Tennessee
city: Houston,
country: United States
facility: Retinal Consultants of Houston,
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
city: Leuven
country: Belgium
facility: U.Z. Leuven St. Rafaël Hospital
city: Lyon
country: France
facility: Rabelais Ophthalmologic Center
city: Marseilles
country: France
facility: Centre Paradis-Monticelli
city: Paris
country: France
facility: Centre Ophtalmologique d'Imagerie et de Laser
city: Paris
country: France
facility: Centre Ophtalmologique de L'Odeon
city: Bonn
country: Germany
facility: Universität Bonn Augenklinik
city: Lübeck
country: Germany
facility: Universität Lübeck Universitätsklinikum Schleswig-Holstein
city: Marburg
country: Germany
facility: Klinik für Augenheilkunde, Universitätsklinikum Gießen, Standort Marburg
city: München
country: Germany
facility: Augenklinik der Ludwig Maximilians Universität München
city: Milan
country: Italy
facility: University of Milan Department of Clinical Science "Luigi Sacco"
city: Rome
country: Italy
facility: Largo Agostino Gemelli (University Hospital) Institute of Ophthalmology
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
state: Camberley
city: Liverpool
country: United Kingdom
facility: Royal Liverpool & Broadgreen Hospital
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
city: Wolverhampton
country: United Kingdom
facility: Wolverhampton Eye Infirmary New Cross Hospital
Study officials:
References: