Study of Intravitreal Microplasmin in Relieving Vitreo-Macular Adhesion in Neovascular Age-related Macular Degeneration

The human vitreous gel undergoes progressive liquefaction with age. Concurrent with the
process of vitreous liquefaction, there is a weakening of the adhesion at the vitreoretinal
interface between the cortical vitreous gel and the inner limiting lamina. Posterior
vitreous detachment (PVD) is a separation of the cortical vitreous get from the inner
limiting lamina. PVD is usually a sudden event during which liquefied vitreous from the
center of the vitreous body bursts through a hole in the posterior vitreous cortex and then
dissects the residual cortex gel away from the inner limiting lamina. If there is residual
vitreoretinal traction around the break, this process may induce a tear in the retina that
can in turn result in rhegmatogenous retinal detachment, macular hole, or cystoid macular
edema. The importance of the vitreous in the progression of diabetic retinopathy may also
extend beyond tractional considerations. For example, it is believed that the vitreous
serves as scaffolding for new vessel formation and may also contribute to molecular
imbalances that lead to retinopathy progression. Therefore, total PVD, by releasing
vitreoretinal traction as well as other potential mechanisms, may be beneficial in various
vitreoretinal diseases such as neovascular AMD.

Vitreomacular adhesion (VMA) in exudative (wet) AMD may be associated with poor prognosis in
patients with AMD. This trial is primarily aimed at showing that release of VMA can be
induced by microplasmin, a proteolytic enzyme, in patients with wet AMD, and that
microplasmin is safe in patients w/ neovascular (wet) AMD. Secondary endpoint will be
assessment of improved AMD outcomes.

Inclusion Criteria:

- Male or female subjects aged 50 years or older

- Presence of focal vitreomacular adhesion as seen by OCT

- BCVA of 20/800 or better in non-study eye

- Presence of active choroidal neovascular membrane

- Written informed consent obtained from subject prior to inclusion in the trial

Exclusion Criteria:

- Subjects who have previously received microplasmin

- Subjects with any vitreous hemorrhage or any other vitreous opacification which
precludes adequate examination or investigation of study eye

- Patient with uncontrolled glaucoma including IOP >25 mm Hg

- Subjects who have had vitrectomy or retinal detachment or who are aphakic or highly
myopic (>8.0 D) in the study eye

- Subjects who are pregnant or of child-bearing potential not utilizing an acceptable
form of contraception. Acceptable methods include intrauterine device, oral,
implanted or injected contraceptives, and barrier methods with spermicide.

- Subjects who, in the Investigator's view, will not complete all visits and
investigations

- Patient who have PDT or any intravitreal injection in the last 10 days. Patients who
in the examiners opinion will need intravitreal injection in the next 10 days (apart
from microplasmin).

- Patients who have participated in an investigational drug trial in the past 30 days.