None listed
Conditions
Interventions
The study will randomize approximately 936 patients at approximately 125 investigational sites globally. This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled st
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: a) General Inclusion Criteria • Willingness to provide signed informed consent. Additionally, at U.S. sites, patients must provide Health Insurance Portability and Accountability Act (HIPAA) authorization, and in other countries, as applicable according to national laws. • Age ≥50 years • For women who are not postmenopausal (≥12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 30 (±7) days after the last dose of study treatment Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Sexually active men will be required to use a barrier contraceptive method (condom), even if they have been surgically sterilized, for the duration of the treatment period and for at least 30 (±7) days after the last dose of study treatment. • Ability and willingness to undertake all scheduled visits and assessments. • Valid CFI profile biomarker result (i.e., CFI profile biomarker-positive or CFI profile biomarker-negative) b) Ocular Inclusion Criteria: Study Eye • BCVA of 20/100 or better (Snellen equivalent) using ETDRS charts at starting distance of 4 m • Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active CNV The total GA lesion size ≥2.54 mm2 (approximately ≥1 disc area [DA]) and ≤17.78 mm2 (approximately ≤7 DA) and must reside completely within the FAF imaging field (Field 2−30 degree image centered on the fovea) If GA is multifocal, at least 1 focal lesion must be ≥1.27 mm2 (approximately ≥0.5 DA) • Presence of hyperautofluorescence of either banded or diffuse patterns adjacent to the area of GA • Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging c) Ocular Inclusion Criteria: Non-study Eye • GA secondary to AMD with no evidence of prior or active CNV • GA lesion must reside completely within the FAF imaging field (Field 2-30 degree image centered on the fovea)
Exclusion criteria
Exclusion criteria: a) GA Characteristics Exclusion Criteria • GA in either eye due to causes other than AMD (monogenetic macular dystrophies [e.g., Stargardt disease, cone rod dystrophy] or toxic maculopathies [e.g., chloroquine/hydroxychloroquine maculopathy]) b) Ocular Exclusion Criteria: Study Eye • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD • Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy • Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy • History of prophylactic subthreshold laser treatment for AMD • Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation). A single intraoperative administration of a corticosteroid during cataract surgery for cystoid macular edema prophylaxis at least 3 months prior to screening is permitted. c) Ocular Exclusion Criteria: Both Eyes • Previous treatment with eculizumab or participation in eculizumab studies • Previous treatment of either eye with lampalizumab • Previous treatment with fenretinide or participation in fenretinide studies d) Ocular Exclusion Criteria: Concurrent Ocular Conditions • Retinal pigment epithelium (RPE) tear that involves the macula in either eye • Any concurrent ocular or intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could do either of the following: Require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition.
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Mexico, New Zealand, Poland, Russian Federation, Slovakia, Spain, Switzerland, United Kindgdom, United States
Contacts
Public ContactRoberto Carrasco
ROCHE FARMA (PERU) S.A.
Outcome results
None listed