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A Study Investigating the Efficacy and Safety of Intravitreal Injections of ANX007 in Patients With Geographic Atrophy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT04656561•Annexon, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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).

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.

Locations (53)

Site 5

Phoenix, Arizona, United States

Site 31

Bakersfield, California, United States

Site 2

Beverly Hills, California, United States

Site 19

Mountain View, California, United States

Site 23

Pasadena, California, United States

Site 37

Poway, California, United States

Site 17

Sacramento, California, United States

Site 18

Santa Ana, California, United States

Site 33

Walnut Creek, California, United States

Site 39

Waterford, Connecticut, United States

Key Dates

Start Date

February 26, 2021

Primary Completion Date

March 28, 2023

Completion Date

September 13, 2023

Last Updated

August 21, 2024

Enrollment

270

ACTUAL participants

Conditions

Geographic Atrophy

Interventions

ANX007

DRUG

Sham comparator

OTHER

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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