None listed
Conditions
Interventions
Lampalizumab
Lampalizumab Drug Product is provided as a sterile, white to off-white, lyophilized powder in a 6-cc USP/European Pharmacopoeia Type 1 glass vial and is intended for intravitreal admin
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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 Valid CFI profile biomarker result (i.e., CFI profile biomarker-positive or CFI profile biomarker-negative) 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 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 • 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: GA in either eye due to causes other than AMD (monogenetic macular dystrophies [e.g., Stargardt disease, cone rod dystrophy] or toxic maculopathies 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. 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 *Retinal pigment epithelium (RPE) tear that involves the macula in either eye • Active uveitis and/or vitritis (grade trace or above) in either eye • History of idiopathic or autoimmune-associated uveitis in either eye • Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye • Current vitreous hemorrhage in the study eye • History of retinal detachment or macular hole (Stage 3 or 4) in the study eye • Aphakia or absence of the posterior capsule in the study eye • Previous violation of the posterior capsule in the study eye unless it occurred as a result of yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation • Spherical equivalent of the refractive error in the study eye demonstrating >8 diopters of myopia • For patients who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye should not have exceeded 8 diopters of myopia. • Intraocular surgery (including cataract surgery) in the study eye within 3 months preceding Day 1
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Hungary, Italy, Mexico, Netherlands, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kindgdom, United States
Contacts
Public ContactRoberto Carrasco
ROCHE FARMA (PERU) S.A.
Outcome results
None listed