A Study Investigating the Efficacy and Safety of Intravitreal Injections of ANX007 in Patients With Geographic Atrophy (ARCHER)

August 20, 2024 updated by: Annexon, Inc.

A Phase 2, Multicenter, Randomized, Parallel-Group, Double-Masked, 4-Arm, Sham-Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 Administered by Intravitreal Injection in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) - The ARCHER Study

This study is being conducted in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) to determine if intravitreal (IVT) injections of ANX007 reduce GA lesion growth rate. The results will be used to guide further development of ANX007 in participants with geographic atrophy. The total duration of participation is expected to be approximately 19 months.

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.
270

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

  • Australia
    • New South Wales
      • Bondi Junction, New South Wales, Australia, 2022
        • Site 49
      • Brookvale, New South Wales, Australia, 2100
        • Site 45
      • Chatswood, New South Wales, Australia, 2067
        • Site 46
      • Sydney, New South Wales, Australia, 2000
        • Site 44
      • Sydney, New South Wales, Australia, 2000
        • Site 47
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Site 48
  • New Zealand
      • Christchurch, New Zealand, 8014
        • Site 50
      • Wellington, New Zealand, 6011
        • Site 51
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Site 5
    • California
      • Bakersfield, California, United States, 93309
        • Site 31
      • Beverly Hills, California, United States, 90211
        • Site 2
      • Mountain View, California, United States, 94040
        • Site 19
      • Pasadena, California, United States, 91107
        • Site 23
      • Poway, California, United States, 92064
        • Site 37
      • Sacramento, California, United States, 95825
        • Site 17
      • Santa Ana, California, United States, 92705
        • Site 18
      • Walnut Creek, California, United States, 94598
        • Site 33
    • Connecticut
      • Waterford, Connecticut, United States, 06385
        • Site 39
    • Florida
      • Fort Myers, Florida, United States, 33907
        • Site 12
      • Jacksonville, Florida, United States, 32216
        • Site 53
      • Pensacola, Florida, United States, 32503
        • Site 26
      • Pinellas Park, Florida, United States, 33782
        • Site 16
      • Saint Petersburg, Florida, United States, 33711
        • Site 28
      • Sarasota, Florida, United States, 34233
        • Site 43
      • Winter Haven, Florida, United States, 33880
        • Site 6
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Site 42
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Site 11
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Site 1
      • Hagerstown, Maryland, United States, 21740
        • Site 41
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Site 36
      • Springfield, Massachusetts, United States, 01107
        • Site 3
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Site 29
    • Nevada
      • Reno, Nevada, United States, 89502
        • Site 10
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Site 38
      • Cherry Hill, New Jersey, United States, 08034
        • Site 9
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Site 30
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Site 20
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Site 52
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Site 13
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Site 40
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Site 27
    • Texas
      • Abilene, Texas, United States, 79606
        • Site 15
      • Austin, Texas, United States, 78750
        • Site 4
      • Bellaire, Texas, United States, 77401
        • Site 24
      • Burleson, Texas, United States, 76028
        • Site 34
      • Dallas, Texas, United States, 75231
        • Site 21
      • Fort Worth, Texas, United States, 76102
        • Site 32
      • Fort Worth, Texas, United States, 76104
        • Site 22
      • Katy, Texas, United States, 77494
        • Site 35
      • San Antonio, Texas, United States, 78240
        • Site 54
      • San Antonio, Texas, United States, 78240
        • Site 8
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Site 14
      • Norfolk, Virginia, United States, 23502
        • Site 25

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:

  • Diagnosis of geographic atrophy of the macula secondary to age-related macular degeneration as determined by the Investigator and confirmed by the Central Reading Center.

  • GA lesion must have the following characteristics as determined by the independent Central Reading Center based on assessment of FAF imaging at screening:

    1. Well-demarcated GA with a total area (baseline lesion size) ≥2.5 millimeter squared (mm^2) and ≤17.5 mm^2.
    2. If GA is multifocal, at least 1 focal lesion must measure ≥1.25 mm^2 with the overall aggregate area of GA as specified above.
    3. Presence of hyper autofluorescence, any pattern, in the junctional zone of the GA. Absence of hyper autofluorescence (that is, pattern = none) is exclusionary.
    4. The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any peripapillary atrophy.
  • Normal luminance BCVA of 24 to 83 letters, inclusive, using ETDRS charts (20/25 to 20/320 Snellen equivalent, inclusive).
  • A female participant is eligible if she is not pregnant or breastfeeding and is a woman of non-childbearing potential or is using a contraceptive method that is highly effective, with a failure rate of <1% during the study intervention period and for at least 30 days after the last dose of study intervention.

Exclusion Criteria:

  • Geographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopathies (for example, plaquenil maculopathy) in either eye.

  • Any evidence of choroidal neovascularization (CNV) in the study eye:

    1. Any history of CNV of any cause based on medical history.
    2. Evidence of prior or active CNV or related findings (for example, retinal pigment epithelial rips or tears) based on FAF, Spectral Domain Optical Coherence Tomography (SD-OCT) imaging, intravenous fluorescein angiography (IVFA) and color fundus photo as assessed by the Central Reading Center.
  • Spherical equivalent of -8.00 diopters (D) myopia or higher in the study eye.
  • Uncontrolled glaucoma in the study eye (Intraocular pressure [IOP] >25 mmHg despite treatment with anti- glaucoma medication) or history of neovascular glaucoma.
  • History of glaucoma filtration surgery, minimally-invasive glaucoma surgery involving an implant, or vitrectomy surgery, or other procedure in the study eye that could affect drug distribution and/or clearance.
  • Any current or prior ocular disease, other than geographic atrophy, that in the opinion of the Investigator could interfere with the conduct of the study including, but not limited to, insufficient pupil dilation, retinal or optic nerve disease, media opacity, or aphakia in the study eye.
  • History of any prior IVT treatment for any indication in the study eye.
  • Any prior treatment for AMD in the study eye (for example, surgical, radiation, thermotherapeutic, or laser intervention), except oral supplements or 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: Quadruple

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: ANX007 Group 1
ANX007 administered every month
Drug: ANX007
Form: solution for injection; Route of Administration: IVT
Experimental: ANX007 Group 2
ANX007 administered every other month
Drug: ANX007
Form: solution for injection; Route of Administration: IVT
Sham Comparator: Sham Group 3
Sham injection administered every month
Other: Sham comparator
Form and Route of Administration: pressure to mimic IVT injection
Sham Comparator: Sham Group 4
Sham injection administered every other month
Other: Sham comparator
Form and Route of Administration: pressure to mimic IVT injection

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
GA lesion growth rate
Time Frame: Baseline to Month 12
Change in GA lesion area as assessed by fundus autofluorescence (FAF)
Baseline to Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety: Participants with treatment-emergent adverse events (TEAEs)
Time Frame: Baseline to Month 18
Number of participants with TEAEs
Baseline to Month 18
Best corrected visual acuity (BCVA)
Time Frame: Baseline to Month 18
Change from baseline in BCVA as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) test chart
Baseline to Month 18
Low-luminance BCVA (LL-BCVA)
Time Frame: Baseline to Month 18
Change from baseline in LL-BCVA
Baseline to Month 18
Low-luminance visual acuity deficit (LL-VD)
Time Frame: Baseline to Month 18
Change from baseline in LL-VD
Baseline to Month 18

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.
Annexon, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Annexon, Inc.

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.
February 26, 2021

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.
March 28, 2023

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.
September 13, 2023

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).
December 1, 2020

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.
December 1, 2020

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 7, 2020

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.
August 21, 2024

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.
August 20, 2024

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.
August 1, 2024

More Information

Terms related to this study

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.
  • ANX007-GA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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