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

NCT04656561 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ANX007-GA-01
• Study Type: interventional
• Target: 270
• Locations: 3 countries
• Sites: 53

Brief 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.

Conditions

Geographic Atrophy

Outcome Measures

Primary Outcomes (1)

• GA lesion growth rate

  Change in GA lesion area as assessed by fundus autofluorescence (FAF)

  Baseline to Month 12

Secondary Outcomes (4)

• Safety: Participants with treatment-emergent adverse events (TEAEs)

  Baseline to Month 18

• Best corrected visual acuity (BCVA)

  Baseline to Month 18

• Low-luminance BCVA (LL-BCVA)

  Baseline to Month 18

• Low-luminance visual acuity deficit (LL-VD)

  Baseline to Month 18

Study Arms (4)

ANX007 Group 1

EXPERIMENTAL

ANX007 administered every month

Drug: ANX007

ANX007 Group 2

EXPERIMENTAL

ANX007 administered every other month

Drug: ANX007

Sham Group 3

SHAM COMPARATOR

Sham injection administered every month

Other: Sham comparator

Sham Group 4

SHAM COMPARATOR

Sham injection administered every other month

Other: Sham comparator

Interventions

ANX007 DRUG

Form: solution for injection; Route of Administration: IVT

ANX007 Group 1; ANX007 Group 2

Sham comparator OTHER

Form and Route of Administration: pressure to mimic IVT injection

Sham Group 3; Sham Group 4

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Well-demarcated GA with a total area (baseline lesion size) ≥2.5 millimeter squared (mm\^2) and ≤17.5 mm\^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.
• 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.

You may not qualify if:

• 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:
• Any history of CNV of any cause based on medical history.
• 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.

Sponsors & Collaborators

• Annexon, Inc.: lead

Study Sites (53)

Site 5

Phoenix, Arizona, 85053, United States

Location

Site 31

Bakersfield, California, 93309, United States

Location

Site 2

Beverly Hills, California, 90211, United States

Location

Site 19

Mountain View, California, 94040, United States

Location

Site 23

Pasadena, California, 91107, United States

Location

Site 37

Poway, California, 92064, United States

Location

Site 17

Sacramento, California, 95825, United States

Location

Site 18

Santa Ana, California, 92705, United States

Location

Site 33

Walnut Creek, California, 94598, United States

Location

Site 39

Waterford, Connecticut, 06385, United States

Location

Site 12

Fort Myers, Florida, 33907, United States

Location

Site 53

Jacksonville, Florida, 32216, United States

Location

Site 26

Pensacola, Florida, 32503, United States

Location

Site 16

Pinellas Park, Florida, 33782, United States

Location

Site 43

Sarasota, Florida, 34233, United States

Location

Site 28

St. Petersburg, Florida, 33711, United States

Location

Site 6

Winter Haven, Florida, 33880, United States

Location

Site 42

Augusta, Georgia, 30909, United States

Location

Site 11

Lexington, Kentucky, 40509, United States

Location

Site 1

Hagerstown, Maryland, 21740, United States

Location

Site 41

Hagerstown, Maryland, 21740, United States

Location

Site 36

Boston, Massachusetts, 02114, United States

Location

Site 3

Springfield, Massachusetts, 01107, United States

Location

Site 29

Royal Oak, Michigan, 48073, United States

Location

Site 10

Reno, Nevada, 89502, United States

Location

Site 38

Bloomfield, New Jersey, 07003, United States

Location

Site 9

Cherry Hill, New Jersey, 08034, United States

Location

Site 30

Albuquerque, New Mexico, 87109, United States

Location

Site 20

Asheville, North Carolina, 28803, United States

Location

Site 52

Cleveland, Ohio, 44195, United States

Location

Site 13

Edmond, Oklahoma, 73013, United States

Location

Site 40

Eugene, Oregon, 97401, United States

Location

Site 27

Philadelphia, Pennsylvania, 19107, United States

Location

Site 15

Abilene, Texas, 79606, United States

Location

Site 4

Austin, Texas, 78750, United States

Location

Site 24

Bellaire, Texas, 77401, United States

Location

Site 34

Burleson, Texas, 76028, United States

Location

Site 21

Dallas, Texas, 75231, United States

Location

Site 32

Fort Worth, Texas, 76102, United States

Location

Site 22

Fort Worth, Texas, 76104, United States

Location

Site 35

Katy, Texas, 77494, United States

Location

Site 54

San Antonio, Texas, 78240, United States

Location

Site 8

San Antonio, Texas, 78240, United States

Location

Site 14

Charlottesville, Virginia, 22903, United States

Location

Site 25

Norfolk, Virginia, 23502, United States

Location

Site 49

Bondi Junction, New South Wales, 2022, Australia

Location

Site 45

Brookvale, New South Wales, 2100, Australia

Location

Site 46

Chatswood, New South Wales, 2067, Australia

Location

Site 44

Sydney, New South Wales, 2000, Australia

Location

Site 47

Sydney, New South Wales, 2000, Australia

Location

Site 48

Adelaide, South Australia, 5000, Australia

Location

Site 50

Christchurch, 8014, New Zealand

Location

Site 51

Wellington, 6011, New Zealand

Location

Related Publications (1)

• Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.

  PMID: 37314061 DERIVED

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Clinical Trials

  Annexon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 7, 2020
• Study Start: February 26, 2021
• Primary Completion: March 28, 2023
• Study Completion: September 13, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (45); NZ (2); AU (6)