A Phase 2, Randomized, Placebo-Controlled, Double-Masked Study to Assess Safety and Efficacy of Multiple Doses of IONIS-FB-LRX, an Antisense Inhibitor of Complement Factor B, in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)

Ionis Pharmaceuticals, Inc.0 个研究点目标入组 330 人开始时间: 2021年6月22日最近更新: 2023年8月21日

试验速览

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•1. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal.
•2. Vaccination against Neisseria meningitidis and Streptococcus pneumoniae received at least 2 weeks prior to first dose of investigational product
•3. Well-demarcated geographic atrophy (GA) due to AMD
•4. Best-corrected visual acuity (BCVA) letter score of 35 letters (approx. 20/200 Snellen equivalent) or better on the ETDRS chart
•5. Must have clear ocular media and adequate pupillary dilation in the study eye to permit high-quality fundus imaging
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 305

•1.Clinically-significant abnormalities in medical history
•2. A lack of full recovery from any infection for at least 14 days prior to the Study Drug administration
•3. Chronic treatment with steroids, including topically or intravitreally administered
•4. History or presence of diabetic retinopathy or diabetic macular edema (DME)
•5. History or presence of a disease other than AMD that could affect vision or safety assessments
•6. Prior treatment with another investigational drug, biological agent, or device
•7. Other protocol-specified inclusion/exclusion criteria may apply

发起方