Status:
COMPLETED
Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion
Lead Sponsor:
ThromboGenics
Conditions:
Exudative Age-Related Macular Degeneration
Focal Vitreomacular Adhesion
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 intr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00913744
Start Date
January 1 2010
End Date
April 1 2013
Last Update
December 17 2014
Active Locations (27)
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1
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
2
Retinal Consultants Medical Group
Sacramento, California, United States, 95819
3
University of Colorado Denver
Aurora, Colorado, United States, 80045
4
Center for Retina and Maculla Disease
Winter Haven, Florida, United States, 33880