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

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: Active, not recruiting
• Conditions: Geographic Atrophy
• Intervention / Treatment: Drug: ANX007; Other: Sham comparator

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Participants with treatment-emergent adverse events (TEAEs)	Number of participants with TEAEs	Baseline to Month 18
Best corrected visual acuity (BCVA)	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)	Change from baseline in LL-BCVA	Baseline to Month 18
Low-luminance visual acuity deficit (LL-VD)	Change from baseline in LL-VD	Baseline to Month 18

Collaborators and Investigators

• Sponsor: Annexon, Inc.
• Investigators: Study Director: Clinical Trials, Annexon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Pathological Conditions, Anatomical; Macular Degeneration; Geographic Atrophy; Atrophy
• Other Study ID 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