Exudative Age-Related Macular Degeneration Clinical Trial
— MIVI-5Official 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)
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).
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
ThromboGenics |
United States, Belgium, France, Germany, Italy, United Kingdom,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT01950741 -
Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy
|
Phase 4 | |
Recruiting |
NCT01608113 -
Long-term Follow-up of Subfoveal Neovascular AMD
|
N/A | |
Completed |
NCT01404845 -
Macular Pigment Density Evolution in Unilateral Wet AMD Versus Non AMD Patients With or Without Lutein and Zeaxanthine Supplementation
|
N/A | |
Completed |
NCT01213082 -
ProspectiveTrial of Proton Beam Combined With Anti-VEGF Therapy for Exudative Age-related Macular Degeneration (AMD)
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01961414 -
Treat and Extend Therapy Study Using Intravitreal Aflibercept for Patients Exited From Protocol VGFT-OD 0910
|
Phase 4 | |
Completed |
NCT01304693 -
ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients
|
Phase 1/Phase 2 | |
Completed |
NCT01810042 -
Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab
|
Phase 4 | |
Completed |
NCT04640272 -
A Multi-Center, Open Label, Extension Study Assessing the Efficacy and Safety of Additional Intravitreal Injections of RBM-007 in Subjects With Wet Age-related Macular Degeneration
|
Phase 2 | |
Active, not recruiting |
NCT02976194 -
Intraocular Cytokine in Recurrence of Polypoidal Choroidal Vasculopathy
|
Phase 4 | |
Completed |
NCT01500915 -
FUSION Regimen: Combined Pro re Nata and Fixed Regimen Ranibizumab in Exudative Age-related Macular Degeneration
|
Phase 4 | |
Enrolling by invitation |
NCT05539235 -
Efficacy and Safety of Intravitreal Conbercept With Modified Treat-and-Extend Regimens in Exudative AMD
|
Phase 2/Phase 3 | |
Completed |
NCT02355028 -
LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration
|
Phase 2 | |
Unknown status |
NCT02089503 -
Monocentric Retrospective Observational Study on Patients With Macular Degeneration
|
N/A | |
Completed |
NCT01796964 -
Efficacy and Safety Study of ESBA1008 Versus EYLEA®
|
Phase 2 | |
Completed |
NCT01127360 -
LUCAS (Lucentis Compared to Avastin Study)
|
Phase 4 | |
Terminated |
NCT02348359 -
X-82 to Treat Age-related Macular Degeneration
|
Phase 2 | |
Recruiting |
NCT02328209 -
Evaluation of the Simplified Treat And Extend Regimen Using Ranibizumab in Exudative Age Related Macular Degeneration
|
N/A | |
Completed |
NCT01849692 -
ESBA1008 Microvolume Study
|
Phase 2 | |
Completed |
NCT01157065 -
Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration
|
Phase 2 | |
Completed |
NCT04138420 -
Evaluation of Retinal and Vascular Features in Macular Degeneration After Intravitreal Injections of Bevacizumab
|