Clinical trial NCT04656561: A Study Investigating the Efficacy and Safety of Intravitreal Injections of ANX007 in Patients With Geographic Atrophy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Geographic Atrophy
Lead sponsor: Annexon, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-07
Enrollment: 270
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: GA lesion growth rate
timeFrame: Baseline to Month 12
Secondary outcomes:
measure: Safety: Participants with treatment-emergent adverse events (TEAEs)
timeFrame: Baseline to Month 18
measure: Best corrected visual acuity (BCVA)
timeFrame: Baseline to Month 18
measure: Low-luminance BCVA (LL-BCVA)
timeFrame: Baseline to Month 18
measure: Low-luminance visual acuity deficit (LL-VD)
timeFrame: Baseline to Month 18
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site 5
state: Arizona
city: Bakersfield
country: United States
facility: Site 31
state: California
city: Beverly Hills
country: United States
facility: Site 2
state: California
city: Mountain View
country: United States
facility: Site 19
state: California
city: Pasadena
country: United States
facility: Site 23
state: California
city: Poway
country: United States
facility: Site 37
state: California
city: Sacramento
country: United States
facility: Site 17
state: California
city: Santa Ana
country: United States
facility: Site 18
state: California
city: Walnut Creek
country: United States
facility: Site 33
state: California
city: Waterford
country: United States
facility: Site 39
state: Connecticut
city: Fort Myers
country: United States
facility: Site 12
state: Florida
city: Jacksonville
country: United States
facility: Site 53
state: Florida
city: Pensacola
country: United States
facility: Site 26
state: Florida
city: Pinellas Park
country: United States
facility: Site 16
state: Florida
city: Saint Petersburg
country: United States
facility: Site 28
state: Florida
city: Sarasota
country: United States
facility: Site 43
state: Florida
city: Winter Haven
country: United States
facility: Site 6
state: Florida
city: Augusta
country: United States
facility: Site 42
state: Georgia
city: Lexington
country: United States
facility: Site 11
state: Kentucky
city: Hagerstown
country: United States
facility: Site 1
state: Maryland
city: Hagerstown
country: United States
facility: Site 41
state: Maryland
city: Boston
country: United States
facility: Site 36
state: Massachusetts
city: Springfield
country: United States
facility: Site 3
state: Massachusetts
city: Royal Oak
country: United States
facility: Site 29
state: Michigan
city: Reno
country: United States
facility: Site 10
state: Nevada
city: Bloomfield
country: United States
facility: Site 38
state: New Jersey
city: Cherry Hill
country: United States
facility: Site 9
state: New Jersey
city: Albuquerque
country: United States
facility: Site 30
state: New Mexico
city: Asheville
country: United States
facility: Site 20
state: North Carolina
city: Cleveland
country: United States
facility: Site 52
state: Ohio
city: Edmond
country: United States
facility: Site 13
state: Oklahoma
city: Eugene
country: United States
facility: Site 40
state: Oregon
city: Philadelphia
country: United States
facility: Site 27
state: Pennsylvania
city: Abilene
country: United States
facility: Site 15
state: Texas
city: Austin
country: United States
facility: Site 4
state: Texas
city: Bellaire
country: United States
facility: Site 24
state: Texas
city: Burleson
country: United States
facility: Site 34
state: Texas
city: Dallas
country: United States
facility: Site 21
state: Texas
city: Fort Worth
country: United States
facility: Site 32
state: Texas
city: Fort Worth
country: United States
facility: Site 22
state: Texas
city: Katy
country: United States
facility: Site 35
state: Texas
city: San Antonio
country: United States
facility: Site 54
state: Texas
city: San Antonio
country: United States
facility: Site 8
state: Texas
city: Charlottesville
country: United States
facility: Site 14
state: Virginia
city: Norfolk
country: United States
facility: Site 25
state: Virginia
city: Bondi Junction
country: Australia
facility: Site 49
state: New South Wales
city: Brookvale
country: Australia
facility: Site 45
state: New South Wales
city: Chatswood
country: Australia
facility: Site 46
state: New South Wales
city: Sydney
country: Australia
facility: Site 44
state: New South Wales
city: Sydney
country: Australia
facility: Site 47
state: New South Wales
city: Adelaide
country: Australia
facility: Site 48
state: South Australia
city: Christchurch
country: New Zealand
facility: Site 50
city: Wellington
country: New Zealand
facility: Site 51
Study officials:
affiliation: Annexon, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: