prophylactic ranibizumab for exudative age-related macular degeneration

Conditions: Age-related Macular Degeneration

Summary: to evaluate ranibizumab as prophylaxis against the conversion to neovascular 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.

Eligibility criteria:
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