Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion
Condition: Exudative Age-Related Macular Degeneration; Focal Vitreomacular Adhesion
MeSH terms: Macular Degeneration; Wet Macular Degeneration; Tissue Adhesions
Intervention: Ocriplasmin; Sham injection
Intervention description: ocriplasmin intravitreal injection (125 µg); Sham injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD

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).
    

Eligibility criteria:

        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.