20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD)

The study is being done to test the safety and effectiveness of an investigational drug
20089 TA that will be used in combination with Lucentis for the treatment of CNVM. In CNVM,
tiny abnormal blood vessels grow through the retinal layers in the eye. These vessels are
very fragile and can leak or bleed. The severity of the symptoms depends on the size of the
CNVM and its proximity to the macula (the center of visual field). Symptoms may be mild
such as a blurry or distorted area of vision, or more severe, like a central blind spot.
Although Lucentis has been approved by the U.S. Food and Drug Administration (FDA) for the
treatment of CNVM, the study drug 20089 TA has not yet been approved, and therefore is
considered an investigational drug.

Triamcinolone Acetonide (TA) is a corticosteroid (an anti-inflammatory drug) that is used to
treat many eye diseases, such as: macular edema (where inflammation causes thickening of
the macula), diabetic eye disease, and age-related macular degeneration. TA has also been
shown to be effective in treating neovascular AMD (also known as "wet AMD") where there is
an abnormal growth of blood vessels in the macula.

Study drug 20089 is an experimental form of the corticosteroid, Triamcinolone Acetonide(TA).
20089 is a new slow-release formula (longer lasting) for intravitreal (into the eye)
delivery of TA. This drug releases the active agent TA over a period of approximately 6
months thereby allowing for the improvement of inflammation and/or complications following
neovascular AMD.

Although intravitreal Lucentis has been shown to prevent the loss of vision in most
neovascular AMD patients and help gain visual acuity (how well we can see), results can only
be assured if monthly injections are given. Since monthly injections are a burden on the
patient and caregiver, attempts are being made to reduce the burden by combining available
treatment options. We hope that by combining 20089 TA with Lucentis a decrease in retinal
inflammation, closure of the leaky vessels with a decrease in the number of monthly
injections could be achieved.