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OpenTrials
Completed

NCT Number: NCT03362190

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

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)

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Budapest Retina Associates, Budapest, Hungary

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avacincaptad Pegol

Drug

Avacincaptad Pegol in combination with Lucentis

Other names: Zimura (previous name), IZERVAY, ARC1905

Lucentis

Drug

Avacincaptad Pegol in combination with Lucentis

Other names: ranibizumab

Primary outcomes

  1. Systemic Adverse Events

    Time frame: 6 months

    Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)

  2. Ophthalmic Adverse Events

    Time frame: 6 months

    Number of participants with ophthalmic Adverse Events (with calculated percentage)

Other outcomes

  1. Change From Baseline - ECG

    Time frame: 6 months

    Number of patients with a change on their Month 6 ECG when compared to their baseline ECG

  2. Mean Change From Baseline - Study Eye ETDRS Visual Acuity

    Time frame: 6 months

    Mean change from Baseline to Month 6 in the number of letters read by the study eye using the ETDRS Visual Acuity charts. Higher ETDRS letters represents better vision and a larger change in ETDRS letters represents better functioning.

  3. Mean Change From Baseline - Vital Signs

    Time frame: 6 months

    Mean change from Baseline to Month 6 in blood pressure (mm Hg). A negative number indicates a decrease and a positive number indicates an increase.

Sponsors and collaborators

Lead sponsor

Ophthotech Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2017
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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