Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion (MIVI-5)
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| ClinicalTrials.gov Identifier: NCT00913744 |
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Recruitment Status :
Completed
First Posted : June 4, 2009
Results First Posted : May 5, 2014
Last Update Posted : December 17, 2014
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Sponsor:
ThromboGenics
Information provided by (Responsible Party):
ThromboGenics
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Exudative Age-Related Macular Degeneration Focal Vitreomacular Adhesion | Drug: Ocriplasmin Drug: Sham injection | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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) |
| Study Start Date : | January 2010 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | April 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Age-related macular degeneration
Drug Information available for:
Ocriplasmin
| Arm | Intervention/treatment |
|---|---|
| Experimental: Ocriplasmin |
Drug: Ocriplasmin
ocriplasmin intravitreal injection (125 µg) |
| Sham Comparator: Sham injection |
Drug: Sham injection
Sham injection |
Primary Outcome Measures :
- Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28 [ Time Frame: Day 28 ]The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation
Information from the National Library of Medicine
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913744
Locations
Show 27 study locations
Sponsors and Collaborators
ThromboGenics
| Responsible Party: | ThromboGenics |
| ClinicalTrials.gov Identifier: | NCT00913744 |
| Other Study ID Numbers: |
TG-MV-005 |
| First Posted: | June 4, 2009 Key Record Dates |
| Results First Posted: | May 5, 2014 |
| Last Update Posted: | December 17, 2014 |
| Last Verified: | April 2014 |
Keywords provided by ThromboGenics:
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AMD |
Additional relevant MeSH terms:
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Macular Degeneration Wet Macular Degeneration Tissue Adhesions Retinal Degeneration Retinal Diseases |
Eye Diseases Cicatrix Fibrosis Pathologic Processes |