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

ThromboGenics

Status and phase: Completed; Phase 2

Conditions: Exudative Age-Related Macular Degeneration; Focal Vitreomacular Adhesion

Treatments: Drug: Sham injection; Drug: Ocriplasmin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913744

TG-MV-005

Details and patient eligibility

About

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).

Enrollment: 100 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Ocriplasmin

Experimental group

Treatment:

Drug: Ocriplasmin

Sham injection

Sham Comparator group

Treatment:

Drug: Sham injection