Prophylactic Ranibizumab for Exudative Age-Related Macular Degeneration

This is an open-label, prospective, randomized study of intravitreally administered
ranibizumab 0.5 mg in subjects with unilateral neovascular AMD in which the fellow (study)
eye is at high-risk for also developing conversion to neovascular AMD.

The Study will determine the efficacy of a quarterly injection of Ranibizumab to prevent the
conversion of dry age-related macular degeneration to neovascular AMD in high risk eyes.

Inclusion Criteria:

- Adults over 50 years old

- Able to sign informed consent and comply with the study protocol for the duration of
the two years.

- Nonexudative age-related macular degeneration (AMD) in one eye (study eye) •At time of
enrollment, fellow non-study eye must have recently diagnosed (not more than 2 years
prior to enrollment), angiographically documented, previously untreated prior to
diagnosis, CNV lesion (i.e., leakage on fluorescein angiography AND subretinal,
intraretinal, or sub-RPE fluid on OCT) secondary to age-related macular degeneration.

Exclusion Criteria:

- Previous treatment with verteporfin PDT, Macugen®, Lucentis®, intravitreal Avastin®,
intravitreal Eylea®, thermal laser, external beam radiation or other AMD therapy in
the study eye.

- History of macular hole in study eye.

- History of vitrectomy in study eye.

- Lens extraction or implantation within the last 3 months.

- Capsulotomy within the last 1 month.

- Lens or other media opacity that would preclude good fundus photography or angiography
within the next 2 years.

- Nevus > 2 disc areas within 3000 microns of the foveal center or with fluid or leakage
on fluorescein angiography.

- Macular edema or signs of diabetic retinopathy more severe than 10 red dots
(microaneurysms or blot hemorrhages).

- Retinal changes related to high myopia and no myopic correction greater than 8.00
diopters spherical equivalent [sphere + ½ cylinder].

- Any progressive ocular disease that would affect visual acuity within the next 2
years.

- Previous participation in any studies of investigational drugs likely to have ocular
effects within 30 days preceding the initial study treatment.

- Concurrent use of systemic anti-VEGF agents.

- Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in
the study eye.

- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either
eye.

- For subjects who have undergone prior refractive or cataract surgery in the study eye,
the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia.

- Uncontrolled glaucoma in the study eye (defined as intraocular pressure > 25 mmHg)
despite treatment with antiglaucoma medication).

- Patients who are unable to be photographed to document CNV due to known allergy to
fluorescein dye, lack of venous access or cataract obscuring the CNV.

- Patients with other ocular diseases that can compromise the visual acuity of the study
eye such as amblyopia and anterior ischemic optic neuropathy.

- Current treatment for active systemic infection.

- Evidence of significant uncontrolled concomitant diseases such as cardiovascular
disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal
disorders.

- History of recurrent significant infections or bacterial infections.

- Inability to comply with study or follow-up procedures.

- Pregnancy (positive pregnancy test) or lactation Premenopausal women not using
adequate contraception. The following are considered effective means of contraception:
surgical sterilization or use of oral contraceptives, barrier contraception with
either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or
contraceptive hormone implant or patch.

- Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated

- Participation in another simultaneous medical investigation or trial