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)
- Conditions
- Geographic atrophy (GA) secondary to age-related macular degeneration (AMD)10010463
- Registration Number
- NL-OMON51185
- Lead Sponsor
- Ionis Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 4
A full list of the inclusion criteria can be found in section 5.1 of the
protocol. Below a list of the most important criteria:
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
A full list of the exclusion criteria can be found in section 5.2 of the
protocol. Below a list of the most important criteria:
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is the absolute change in the GA area at Week 49<br /><br>compared to baseline, as measured by FAF in study eye.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary efficacy endpoints include:<br /><br>• Percent change in levels of plasma FB from Baseline<br /><br><br /><br>The secondary efficacy endpoints include:<br /><br>• Percent change in levels of serum AH50 activity from Baseline<br /><br>• Absolute change in LLVA score from Baseline at Week 49 </p><br>