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

Completed · Phase 2 · Has a placebo group

Conditions studied: Geographic Atrophy

In brief

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.

Key facts

Study ID

NCT04656561

Run by

Annexon, Inc.

People needed

270

Starts

2021-02-26

Expected to finish

2023-09-13

Last updated by the study team

2024-08-21

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Presence of hyper autofluorescence, any pattern, in the junctional zone of the GA. Absence of hyper autofluorescence (that is, pattern = none) is exclusionary.
• 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.

Where it is running

• 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 5 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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