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

  • STATUS
    Recruiting
  • End date
    Dec 13, 2023
  • participants needed
    240
  • sponsor
    Annexon, Inc.
Updated on 13 March 2021

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.

Details
Condition Dry Macular Degeneration, age-related macular degeneration, Macular Degeneration, Geographic Atrophy
Treatment Sham comparator, ANX007
Clinical Study IdentifierNCT04656561
SponsorAnnexon, Inc.
Last Modified on13 March 2021

Eligibility

Yes No Not Sure

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
Well-demarcated GA with a total area (baseline lesion size) 2.5 mm2 and 17.5 mm2
If GA is multifocal, at least 1 focal lesion must measure 1.25 mm2 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 (ie, 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 best corrected visual acuity (BCVA) of 24 to 83 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (20/25 to 20/320 Snellen equivalent, inclusive)
A female patient 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 (eg, 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 (eg, retinal pigment epithelial rips or tears) based on FAF, 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 (IOP >25 mmHg despite treatment with antiglaucoma 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 (eg, surgical, radiation, thermotherapeutic, or laser intervention), except oral supplements or minerals
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