Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion - Full Text View

Purpose

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).

Condition	Intervention	Phase
Exudative Age-Related Macular Degeneration Focal Vitreomacular Adhesion	Drug: Ocriplasmin Drug: Sham injection	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, Multicenter Trial of Ocriplasmin Intravitreal Injection for Treatment of Focal Vitreomacular Adhesion in Subjects With Exudative Age-Related Macular Degeneration (AMD)

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration

MedlinePlus related topics: Adhesions Macular Degeneration

Drug Information available for: Ocriplasmin

U.S. FDA Resources

Further study details as provided by ThromboGenics:

Primary Outcome Measures:

Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation


Enrollment:	100
Study Start Date:	January 2010
Study Completion Date:	April 2013
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ocriplasmin	Drug: Ocriplasmin ocriplasmin intravitreal injection (125 µg)
Sham Comparator: Sham injection	Drug: Sham injection Sham injection

Eligibility


Ages Eligible for Study:	50 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects aged > 50
Presence of focal vitreomacular adhesion measured by Optical Coherence Tomography (OCT).
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.
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
The total lesion area must be < 12 disc areas
Subjects who have previously received at least three antiangiogenic injections(Lucentis® or Avastin®) in the study eye.
Subjects with visual acuity of 20/32 to 20/200 in the study eye
Written informed consent obtained from the subject prior to inclusion in the study

Exclusion Criteria:

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
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.
Subjects who have previously received more than 9 antiangiogenic agent injections (whether Lucentis® or Avastin® or other anti-angiogenic agent) in the study eye
Subjects with history of rhegmatogenous retinal detachment or proliferative vitreoretinopathy (PVR) in the study eye
Subjects with high myopia (> 8D) or aphakia in the study eye
Subjects who have had ocular surgery in the study eye in the prior three months
Subjects 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: NCT00913744

Show 27 Study Locations

Sponsors and Collaborators

ThromboGenics

More Information


Responsible Party:	ThromboGenics
ClinicalTrials.gov Identifier:	NCT00913744 History of Changes
Other Study ID Numbers:	TG-MV-005
Study First Received:	June 2, 2009
Results First Received:	April 2, 2014
Last Updated:	December 2, 2014
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Belgium: Federal Agency for Medicinal Products and Health Products Italy: The Italian Medicines Agency Germany: Federal Institute for Drugs and Medical Devices United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Keywords provided by ThromboGenics:


AMD

Additional relevant MeSH terms:


Macular Degeneration Tissue Adhesions Wet Macular Degeneration Retinal Degeneration Retinal Diseases	Eye Diseases Cicatrix Fibrosis Pathologic Processes

ClinicalTrials.gov processed this record on September 23, 2016

Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion (MIVI-5)