Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) MedDRA version: 20.1 Level: PT Classification code 10064930 Term: Age-related macular degeneration System Organ Class: 10015919 - Eye disorders MedDRA version: 20.1 Level: LLT Classification code 10063947 Term: Geographic atrophy System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: ISIS 696844
Product Code: ISIS 696844
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ISIS 696844
CAS Number: 2272983-11-4
Current Sponsor code: ISIS 696844
Concentratio
Sponsors
Ionis Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 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 330
Exclusion criteria
Exclusion 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 7. Other protocol-specified inclusion/exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of ISIS 696844 on the rate of change of the area of Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) measured by fundus autofluorescence (FAF);Secondary Objective: To evaluate the effect of ISIS 696844 on plasma FB levels and serum AH50 activity in AMD patients To assess the effect of ISIS 696844 to slow reduction of low luminance visual acuity (LLVA) ;Primary end point(s): The primary efficacy endpoint is the absolute change in the GA area at Week 49 compared to baseline, as measured by FAF in study eye.;Timepoint(s) of evaluation of this end point: Week 49 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints include: • Percent change in levels of plasma FB from Baseline • Percent change in levels of serum AH50 activity from Baseline • Absolute change in LLVA score from Baseline at Week 49 ;Timepoint(s) of evaluation of this end point: Please, refer to Appendix A in the protocol for a detailed schedule of procedures | — |
Countries
Australia, Austria, Canada, Czechia, Czech Republic, Hungary, Netherlands, New Zealand, Poland, Spain, United States
Contacts
Public ContactIonis Clinical Trial Information
Ionis Pharmaceuticals, Inc.
Outcome results
None listed