Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion (MIVI-5)
This study has been completed.
Sponsor:
ThromboGenics
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00913744
First received: June 2, 2009
Last updated: December 2, 2014
Last verified: April 2014
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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
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 |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00913744
Show 27 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913744
Show 27 Study Locations
Sponsors and Collaborators
ThromboGenics
More Information
No publications provided
| 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 Wet Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases |
ClinicalTrials.gov processed this record on March 03, 2015