Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration

Age-related macular degeneration (AMD) is the leading cause of severe vision
loss in people over the age of 65 in the United States (US) and other Western
countries. Without treatment, neovascular AMD results in severe visual
impairment with an average loss of around 4 lines of visual acuity within 2
years of disease onset.

A drawback of current treatments for neovascular AMD treatments is the need to
frequently administer intravitreal injections.It would be highly desirable to
develop an agent that requires less frequent injections
.

To evaluate the safety and efficacy of abicipar (2 mg), compared to 0.5 mg
ranibizumab in treatment-naïve patients with neovascular AMD.

Structure:
Multicenter, randomized, double-masked, parallel-group, active-controlled study

Duration:
104 weeks participation for each patient following randomization

Randomization/Stratification:
Patients will be randomized by region to 3 treatment groups (2Q8, 2Q12, and
rQ4). Within each region, allocation to treatment groups will be stratified by
the following 3 factors using a ratio of 1:1:1:
* Disease characteristics of the study eye assessed by the investigator at
screening and subsequently
confirmed by the central reading center prior to baseline (D1):
o Lesion type of choroidal neovascularization (predominantly classic versus
minimally classic or occult)
o Central retinal thickness (CRT) defined as the central 1000 microns from
center of fovea (values * 400 *m versus > 400 *m) as measured from the internal
limiting membrane to the top of the retinal pigment epithelium
* Best-corrected visual acuity (BCVA) (* 55 letters versus > 55 letters)
assessed at baseline (D1)

Study Treatment Groups and Dosage/Dose Regimen:
* Treatment group 2Q8: 2 mg abicipar administered at baseline (D1) and weeks 4
and 8, followed by doses at 8-week intervals through week 96
* Treatment group 2Q12: 2 mg abicipar administered at baseline (D1), and weeks
4 and 12, followed by doses at 12-week intervals through week 96

Controls:
* Treatment group rQ4: 0.5 mg ranibizumab administered every 4 weeks through
week 96
The treating investigator will administer the masked study medication by
intravitreal injection into the study eye at the assigned visits.

There are possible side effects and discomforts associated with the procedures
and study treatment. Patients may experience some, all, or none of these
effects. The possible side effects and discomforts associated with study
procedures and study treatment are described in Addendum VI of the patient
Information Leaflet.
There may be side effects or discomforts from the study treatment that are not
yet known including worsening of the macular degeneration.

Pregnancy Risks:
If you are pregnant or become pregnant, there may be risks to the foetus which
are currently unknown.