A Study Investigating the Efficacy and Safety of Intravitreal Injections of ANX007 in Patients With Geographic Atrophy
NCT ID: NCT04656561
Last Updated: 2024-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
270 participants
INTERVENTIONAL
2021-02-26
2023-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ANX007 Group 1
ANX007 administered every month
ANX007
Form: solution for injection; Route of Administration: IVT
ANX007 Group 2
ANX007 administered every other month
ANX007
Form: solution for injection; Route of Administration: IVT
Sham Group 3
Sham injection administered every month
Sham comparator
Form and Route of Administration: pressure to mimic IVT injection
Sham Group 4
Sham injection administered every other month
Sham comparator
Form and Route of Administration: pressure to mimic IVT injection
Interventions
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ANX007
Form: solution for injection; Route of Administration: IVT
Sham comparator
Form and Route of Administration: pressure to mimic IVT injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
ALL
No
Sponsors
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Annexon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Annexon, Inc.
Locations
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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
Site 12
Fort Myers, Florida, United States
Site 53
Jacksonville, Florida, United States
Site 26
Pensacola, Florida, United States
Site 16
Pinellas Park, Florida, United States
Site 43
Sarasota, Florida, United States
Site 28
St. Petersburg, Florida, United States
Site 6
Winter Haven, Florida, United States
Site 42
Augusta, Georgia, United States
Site 11
Lexington, Kentucky, United States
Site 1
Hagerstown, Maryland, United States
Site 41
Hagerstown, Maryland, United States
Site 36
Boston, Massachusetts, United States
Site 3
Springfield, Massachusetts, United States
Site 29
Royal Oak, Michigan, United States
Site 10
Reno, Nevada, United States
Site 38
Bloomfield, New Jersey, United States
Site 9
Cherry Hill, New Jersey, United States
Site 30
Albuquerque, New Mexico, United States
Site 20
Asheville, North Carolina, United States
Site 52
Cleveland, Ohio, United States
Site 13
Edmond, Oklahoma, United States
Site 40
Eugene, Oregon, United States
Site 27
Philadelphia, Pennsylvania, United States
Site 15
Abilene, Texas, United States
Site 4
Austin, Texas, United States
Site 24
Bellaire, Texas, United States
Site 34
Burleson, Texas, United States
Site 21
Dallas, Texas, United States
Site 32
Fort Worth, Texas, United States
Site 22
Fort Worth, Texas, United States
Site 35
Katy, Texas, United States
Site 54
San Antonio, Texas, United States
Site 8
San Antonio, Texas, United States
Site 14
Charlottesville, Virginia, United States
Site 25
Norfolk, Virginia, United States
Site 49
Bondi Junction, New South Wales, Australia
Site 45
Brookvale, New South Wales, Australia
Site 46
Chatswood, New South Wales, Australia
Site 44
Sydney, New South Wales, Australia
Site 47
Sydney, New South Wales, Australia
Site 48
Adelaide, South Australia, Australia
Site 50
Christchurch, , New Zealand
Site 51
Wellington, , New Zealand
Countries
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References
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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.
Other Identifiers
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ANX007-GA-01
Identifier Type: -
Identifier Source: org_study_id
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