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

Study Overview
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Brief Summary
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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)

Official Title
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A Phase 2A Open-label Trial to Assess the Safety of ZIMURA™ (Anti-C5) Administered in Combination With LUCENTIS® 0.5 mg in Treatment Naive Subjects With Neovascular Age Related Macular Degeneration

Conditions
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Wet Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Zimura
* Drug: Lucentis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Zimura dosage 1 + Lucentis 0.5 mg | Drug: Zimura<br>* Zimura in combination with Lucentis<br>* Other names: avacincaptad pegol;Drug: Lucentis<br>* Zimura in combination with Lucentis<br>* Other names: ranibizumab;|
| Experimental: Cohort 2<br>Zimura dosage 2 + Lucentis 0.5 mg | Drug: Zimura<br>* Zimura in combination with Lucentis<br>* Other names: avacincaptad pegol;Drug: Lucentis<br>* Zimura in combination with Lucentis<br>* Other names: ranibizumab;|
| Experimental: Cohort 3<br>Zimura dosage 3 + Lucentis 0.5 mg | Drug: Zimura<br>* Zimura in combination with Lucentis<br>* Other names: avacincaptad pegol;Drug: Lucentis<br>* Zimura in combination with Lucentis<br>* Other names: ranibizumab;|
| Experimental: Cohort 4<br>Zimura dosage 4 + Lucentis 0.5 mg | Drug: Zimura<br>* Zimura in combination with Lucentis<br>* Other names: avacincaptad pegol;Drug: Lucentis<br>* Zimura in combination with Lucentis<br>* Other names: ranibizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic Adverse Events | Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage) | 6 months | 
| Ophthalmic Adverse Events | Number of participants with ophthalmic Adverse Events (with calculated percentage) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zimura, ARC1905, Lucentis, ranibizumab, Wet AMD, avacincaptad pegol, complement factor C5 inhibitor