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

Geographic Atrophy Clinical Trial

— ARCHER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04656561
• Other study ID #: ANX007-GA-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 26, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: Annexon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 270
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy

Intervention

Drug:
• ANX007
Form: solution for injection; Route of Administration: IVT

Other:
• Sham comparator
Form and Route of Administration: pressure to mimic IVT injection

Locations

Country	Name	City	State
Australia	Site 48	Adelaide	South Australia
Australia	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
New Zealand	Site 50	Christchurch
New Zealand	Site 51	Wellington
United States	Site 15	Abilene	Texas
United States	Site 30	Albuquerque	New Mexico
United States	Site 20	Asheville	North Carolina
United States	Site 42	Augusta	Georgia
United States	Site 4	Austin	Texas
United States	Site 31	Bakersfield	California
United States	Site 24	Bellaire	Texas
United States	Site 2	Beverly Hills	California
United States	Site 38	Bloomfield	New Jersey
United States	Site 36	Boston	Massachusetts
United States	Site 34	Burleson	Texas
United States	Site 14	Charlottesville	Virginia
United States	Site 9	Cherry Hill	New Jersey
United States	Site 52	Cleveland	Ohio
United States	Site 21	Dallas	Texas
United States	Site 13	Edmond	Oklahoma
United States	Site 40	Eugene	Oregon
United States	Site 12	Fort Myers	Florida
United States	Site 22	Fort Worth	Texas
United States	Site 32	Fort Worth	Texas
United States	Site 1	Hagerstown	Maryland
United States	Site 41	Hagerstown	Maryland
United States	Site 53	Jacksonville	Florida
United States	Site 35	Katy	Texas
United States	Site 11	Lexington	Kentucky
United States	Site 19	Mountain View	California
United States	Site 25	Norfolk	Virginia
United States	Site 23	Pasadena	California
United States	Site 26	Pensacola	Florida
United States	Site 27	Philadelphia	Pennsylvania
United States	Site 5	Phoenix	Arizona
United States	Site 16	Pinellas Park	Florida
United States	Site 37	Poway	California
United States	Site 10	Reno	Nevada
United States	Site 29	Royal Oak	Michigan
United States	Site 17	Sacramento	California
United States	Site 28	Saint Petersburg	Florida
United States	Site 54	San Antonio	Texas
United States	Site 8	San Antonio	Texas
United States	Site 18	Santa Ana	California
United States	Site 43	Sarasota	Florida
United States	Site 3	Springfield	Massachusetts
United States	Site 33	Walnut Creek	California
United States	Site 39	Waterford	Connecticut
United States	Site 6	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Annexon, Inc.

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GA lesion growth rate	Change in GA lesion area as assessed by fundus autofluorescence (FAF)	Baseline to Month 12
Secondary	Safety: Participants with treatment-emergent adverse events (TEAEs)	Number of participants with TEAEs	Baseline to Month 18
Secondary	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
Secondary	Low-luminance BCVA (LL-BCVA)	Change from baseline in LL-BCVA	Baseline to Month 18
Secondary	Low-luminance visual acuity deficit (LL-VD)	Change from baseline in LL-VD	Baseline to Month 18