Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Iveric Bio

Status and phase: Completed; Phase 3; Phase 2

Conditions: Macular Degeneration; Geographic Atrophy

Treatments: Drug: Zimura; Other: Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT02686658

OPH2003

2015-003991-56 (EudraCT Number)

Details and patient eligibility

About

The objectives of this study were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

Full description

Participants will receive monthly intravitreal injections of Zimura or Sham for 18 months.

Enrollment: 286 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Evidence of Choroidal Neovascularization (CNV)
• GA secondary to any condition other than AMD
• Any prior treatment for AMD 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 three (3) months of trial entry
• Any prior thermal laser in the macular region, regardless of indication
• Any ocular or periocular infection in the twelve (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

---

286 participants in 6 patient groups

Zimura 1 mg [Part 1]

Experimental group

Description:

Participants received 1 mg of Zimura in the study eye administered via IVT injection (50 µL) on Day 1 and monthly up to 18 months.

Treatment:

Drug: Zimura

Zimura 2 mg [Part 1]

Experimental group

Description:

Participants received 2 mg of Zimura in the study eye administered via IVT injection (100 µL) on Day 1 and monthly up to 18 months.

Treatment:

Drug: Zimura

Sham [Part 1]

Sham Comparator group

Description:

Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.

Treatment:

Other: Sham

Zimura 2 mg (Zimura 2mg+Sham) [Part 2]

Experimental group

Description:

Participants received 2 mg of Zimura in the study eye administered via IVT injection (100 µL) and a subsequent Sham administration on Day 1 and monthly up to 18 months.

Treatment:

Other: Sham

Drug: Zimura

Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2]

Experimental group

Description:

Participants received 4 mg of Zimura in the study eye administered via two consecutive IVT injections (2 x 100 µL) on Day 1 and monthly up to 18 months.

Treatment:

Drug: Zimura

Sham (Sham+Sham) [Part 2]

Sham Comparator group

Description:

Participants received two consecutive Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.

Treatment:

Other: Sham