ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)

Ophthotech

Status and phase: Completed; Phase 2

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: Avacincaptad Pegol; Drug: Lucentis

Study type: Interventional

Funder types: Industry

Identifiers

NCT03362190

OPH2007

Details and patient eligibility

About

To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)

Enrollment: 64 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active subfoveal NVAMD

Exclusion criteria

• History or evidence of severe cardiac disease
• Any major surgical procedure within one month of trial entry
• Subjects with a clinically significant laboratory value
• Any treatment with an investigational agent in the past 60 days for any condition
• Women who are pregnant or nursing
• Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation
• Any prior treatment for AMD other than oral supplements of vitamins and minerals

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 4 patient groups

Cohort 1

Experimental group

Description:

Avacincaptad Pegol dosage 1 + Lucentis 0.5 mg

Treatment:

Drug: Lucentis

Drug: Avacincaptad Pegol

Cohort 2

Experimental group

Description:

Avacincaptad Pegol dosage 2 + Lucentis 0.5 mg

Treatment:

Drug: Lucentis

Drug: Avacincaptad Pegol

Cohort 3

Experimental group

Description:

Avacincaptad Pegol dosage 3 + Lucentis 0.5 mg

Treatment:

Drug: Lucentis

Drug: Avacincaptad Pegol

Cohort 4

Experimental group

Description:

Avacincaptad Pegol dosage 4 + Lucentis 0.5 mg

Treatment:

Drug: Lucentis

Drug: Avacincaptad Pegol