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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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