Safety Study of Zimura in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD

Iveric Bio

Status and phase: Terminated; Phase 2

Conditions: Neovascular Age-Related Macular Degeneration

Treatments: Drug: Avacincaptad Pegol; Drug: Avastin; Drug: Eylea; Drug: Lucentis

Study type: Interventional

Funder types: Industry

Identifiers

NCT05571267

OPH2004

Details and patient eligibility

About

The primary objective is to assess the safety of intravitreal (IVT) Zimura® administered in combination with anti-VEGF Therapy (AVASTIN®, EYLEA®, OR LUCENTIS®) in anti-VEGF treatment experienced subjects with neovascular age-related macular degeneration (AMD)

Enrollment: 1 patient

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment experienced subjects defined as subjects with 1 prior dose of same intravitreal anti-VEGF therapy given within the past 8 weeks for neovascular age-related macular degeneration (NVAMD) in the study eye. There must be < 0 letters of improvement in Snellen (not ETDRS Snellen equivalent) visual acuity since the start of anti-VEGF treatment.
• Presence of subfoveal active choroidal neovascularization (CNV)

Exclusion criteria

• Intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication, with the exception of the 1 prior anti-VEGF injections.
• Presence of other causes of choroidal neovascularization, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
• Non-pharmacologic treatment (intraocular surgery or thermal laser) within three months of trial entry.
• Prior thermal laser in the macular region, regardless of indication.
• Ocular or periocular infection in the past twelve weeks.
• History of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery, glaucoma drainage device, or corneal transplant.
• Previous therapeutic radiation in the region of the study eye.
• Evidence of diabetic retinopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1 participants in 3 patient groups

Avacincaptad Pegol and Avastin

Experimental group

Description:

Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Avacincaptad Pegol.

Treatment:

Drug: Avastin

Drug: Avacincaptad Pegol

Avacincaptad Pegol and Lucentis

Experimental group

Description:

Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Avacincaptad Pegol.

Treatment:

Drug: Lucentis

Drug: Avacincaptad Pegol

Avacincaptad Pegol and Eylea

Experimental group

Description:

Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Avacincaptad Pegol.

Treatment:

Drug: Eylea

Drug: Avacincaptad Pegol