A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)

Iveric Bio

Status and phase: Completed; Phase 3

Conditions: Macular Degeneration; Geographic Atrophy

Treatments: Drug: Sham; Drug: Avacincaptad Pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT04435366

ISEE2008

Details and patient eligibility

About

The objectives of this study was to evaluate the safety and efficacy of avacincaptad pegol intravitreal administration in participants with geographic atrophy secondary to age-related macular degeneration (AMD)

Full description

Participants were randomized in a 1:1 ratio to the following monthly treatment groups:

• Avacincaptad pegol 2 mg
• Sham

At Month 12, the participants in the avacincaptad pegol 2mg treatment group were re-randomized to receive the study drug either on a monthly basis or on an every other month basis

The participants initially randomized to sham treatment continued with monthly sham administration through Month 23

All participants had a final follow up visit at Month 24

Enrollment: 448 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects of either gender aged ≥ 50 years
• Diagnosis of Non-foveal GA secondary to dry AMD

Exclusion criteria

• Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals
• Any intraocular surgery or thermal laser within 3 months of trial entry.
• Any prior thermal laser in the macular region, regardless of indication
• Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks.
• Previous therapeutic radiation in the region of the study eye
• Any sign of diabetic retinopathy in either eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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448 participants in 3 patient groups

Avacincaptad Pegol

Experimental group

Description:

Participants received avacincaptad pegol (ACP) 2 milligram (mg)/eye via intravitreal (IVT) injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2).

Treatment:

Drug: Avacincaptad Pegol

Sham

Sham Comparator group

Description:

Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham administration from month 12 through month 23 (Year 2).

Treatment:

Drug: Sham

Avacincaptad pegol and Sham

Experimental group

Description:

Participants who received ACP 2mg monthly through Month 11 (Year 1) were re-randomized at month 12, to receive ACP 2 mg/eye via IVT injections every other month at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22.

Treatment:

Drug: Avacincaptad Pegol