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

May 25, 2025 updated by: Ophthotech Corporation

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1076
        • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
      • Budapest, Hungary, 1133
        • Budapest Retina Associates
      • Szeged, Hungary, 6702
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szemeszeti Klinika
  • Latvia
      • Riga, Latvia, LV-1002
        • Pauls Stradins Clinical University Hospital, Clinic of Ophthalmology
      • Riga, Latvia, LV-1050
        • Dr. Solomatin's eye rehabilitation and vision correction centre
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Retinal Research Institute
      • Tucson, Arizona, United States, 85704
        • Retina Centers PC
      • Tucson, Arizona, United States, 85710
        • Retina Associates SW, PC
    • California
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
      • Fullerton, California, United States, 92835
        • Retina Consultants of Orange County
      • Redlands, California, United States, 92374
        • Retina Consultants of Southern California
      • Sacramento, California, United States, 95841
        • Retinal Consultants Medical Group
      • Santa Ana, California, United States, 92705
        • Orange County Retina Medical Group
    • Colorado
      • Golden, Colorado, United States, 80214
        • Colorado Retina Associates
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Florida Eye Clinic
      • Melbourne, Florida, United States, 32901
        • Florida Eye Associates
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Illinois Eye Center
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Vitreo Retinal Consultants & Surgeons
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
        • Vitreoretinal Surgery
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Retina Consultants of Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New York
      • Syracuse, New York, United States, 13224
        • Retina Vitreous Surgeons of CNY, PC
    • Oregon
      • Portland, Oregon, United States, 97221
        • Retina Northwest PC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Charleston Neuroscience Institute
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Avacincaptad Pegol dosage 1 + Lucentis 0.5 mg
Drug: Avacincaptad Pegol
Avacincaptad Pegol in combination with Lucentis
Other Names:
  • ARC1905
  • IZERVAY
  • Zimura (previous name)
Drug: Lucentis
Avacincaptad Pegol in combination with Lucentis
Other Names:
  • ranibizumab
Experimental: Cohort 2
Avacincaptad Pegol dosage 2 + Lucentis 0.5 mg
Drug: Avacincaptad Pegol
Avacincaptad Pegol in combination with Lucentis
Other Names:
  • ARC1905
  • IZERVAY
  • Zimura (previous name)
Drug: Lucentis
Avacincaptad Pegol in combination with Lucentis
Other Names:
  • ranibizumab
Experimental: Cohort 3
Avacincaptad Pegol dosage 3 + Lucentis 0.5 mg
Drug: Avacincaptad Pegol
Avacincaptad Pegol in combination with Lucentis
Other Names:
  • ARC1905
  • IZERVAY
  • Zimura (previous name)
Drug: Lucentis
Avacincaptad Pegol in combination with Lucentis
Other Names:
  • ranibizumab
Experimental: Cohort 4
Avacincaptad Pegol dosage 4 + Lucentis 0.5 mg
Drug: Avacincaptad Pegol
Avacincaptad Pegol in combination with Lucentis
Other Names:
  • ARC1905
  • IZERVAY
  • Zimura (previous name)
Drug: Lucentis
Avacincaptad Pegol in combination with Lucentis
Other Names:
  • ranibizumab

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ophthotech Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2017

Primary Completion (Actual)

October 18, 2018

Study Completion (Actual)

October 18, 2018

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

November 29, 2017

First Posted (Actual)

December 5, 2017

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

May 25, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPH2007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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