Phase
Condition
Myopic Macular Degeneration
Macular Degeneration
Aging
Treatment
N/AClinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed Informed Consent Form
Age ≥ 50 years
Subfoveal CNV secondary to AMD, with evidence of recent disease progression, asdefined by any of the following (lesion is eligible if it meets any one of thefollowing criteria): ≥ 5 letters (or ≥ 1 Snellen line) of BCVA lost within 6 monthspreceding Day 0; ≥ 10% increase in lesion area, as determined by comparing a FAperformed within 1 month preceding Day 0 to a FA performed within 6 months precedingDay 0; Subretinal hemorrhage associated with CNV within 1 month preceding Day 0;Classic CNV comprising > 50% of CNV lesion area
BCVA, using ETDRS charts for Cohort 1 and Snellen charts for Cohort 2, of 20/40 to 20/320 (Snellen equivalent) in the study eye
Exclusion
Exclusion Criteria:
Treatment with verteporfin PDT, pegaptanib sodium, or other AMD therapy in the studyeye < 30 days preceding Day 0
History of submacular surgery or other surgical intervention for AMD in the study eye
Previous participation in any studies of investigational drugs within 30 dayspreceding Day 0 (excluding vitamins and minerals)
Prior participation in a Genentech ranibizumab clinical trial
Treatment with intravitreally administered (in either eye) Avastin(R) (bevacizumab)within 30 days preceding Day 0
Concurrent use of systemic anti-VEGF agents
Fibrosis or atrophy involving the center of the fovea in the study eye, in the absenceof a new lesion
CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, orpathologic myopia
Retinal pigment epithelial tear involving the macula in the study eye
Any concurrent intraocular condition in the study eye (e.g., cataract or diabeticretinopathy) that, in the opinion of the investigator, could either require medical orsurgical intervention during the 12-month study period to prevent or treat visual lossthat might result from that condition, or, if allowed to progress untreated, couldlikely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period
Active intraocular inflammation (grade trace or above) in the study eye
Current vitreous hemorrhage in the study eye
History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in thestudy eye
History of idiopathic or autoimmune-associated uveitis in either eye
Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in eithereye
Aphakia or pseudophakia with absence of the posterior capsule (unless it occurred as aresult of a yttrium aluminum garnet [YAG] posterior capsulotomy)
Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia
Intraocular surgery (including cataract surgery) in the study eye within 2 monthspreceding Day 0
Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHgdespite treatment with antiglaucoma medication)
Concurrent use of more than one therapy for glaucoma
History of glaucoma filtering surgery in the study eye
History of corneal transplant in the study eye
Premenopausal women not using adequate contraception
Pregnancy or lactation
History of other disease, metabolic dysfunction, physical examination finding, orclinical laboratory finding giving reasonable suspicion of a disease or condition thatcontraindicates the use an investigational drug or that might affect interpretation ofthe results of the study or render the subject at high risk for treatmentcomplications
Current treatment for a significant active systemic infection
Evidence of significant uncontrolled concomitant diseases such as cardiovasculardisease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinaldisorders
History of recurrent significant infections or bacterial infections
Inability to comply with study or follow-up procedures