A Study Investigating the Efficacy and Safety of Intravitreal Injections of ANX007 in Patients With Geographic Atrophy (ARCHER)
Primary Purpose
Geographic Atrophy
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ANX007
Sham comparator
Sponsored by
About this trial
This is an interventional treatment trial for Geographic Atrophy
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:
- 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.
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:
- 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.
Sites / Locations
- Site 5
- Site 31
- Site 2
- Site 19
- Site 23
- Site 37
- Site 17
- Site 18
- Site 33
- Site 39
- Site 12
- Site 53
- Site 26
- Site 16
- Site 28
- Site 43
- Site 6
- Site 42
- Site 11
- Site 1
- Site 41
- Site 36
- Site 3
- Site 29
- Site 10
- Site 38
- Site 9
- Site 30
- Site 20
- Site 52
- Site 13
- Site 40
- Site 27
- Site 15
- Site 4
- Site 24
- Site 34
- Site 21
- Site 32
- Site 22
- Site 35
- Site 54
- Site 8
- Site 14
- Site 25
- Site 49
- Site 45
- Site 46
- Site 44
- Site 47
- Site 48
- Site 50
- Site 51
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Sham Comparator
Sham Comparator
Arm Label
ANX007 Group 1
ANX007 Group 2
Sham Group 3
Sham Group 4
Arm Description
ANX007 administered every month
ANX007 administered every other month
Sham injection administered every month
Sham injection administered every other month
Outcomes
Primary Outcome Measures
GA lesion growth rate
Change in GA lesion area as assessed by fundus autofluorescence (FAF)
Secondary Outcome Measures
Safety: Participants with treatment-emergent adverse events (TEAEs)
Number of participants with TEAEs
Best corrected visual acuity (BCVA)
Change from baseline in BCVA as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) test chart
Low-luminance BCVA (LL-BCVA)
Change from baseline in LL-BCVA
Low-luminance visual acuity deficit (LL-VD)
Change from baseline in LL-VD
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04656561
Brief Title
A Study Investigating the Efficacy and Safety of Intravitreal Injections of ANX007 in Patients With Geographic Atrophy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Annexon, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ANX007 Group 1
Arm Type
Experimental
Arm Description
ANX007 administered every month
Arm Title
ANX007 Group 2
Arm Type
Experimental
Arm Description
ANX007 administered every other month
Arm Title
Sham Group 3
Arm Type
Sham Comparator
Arm Description
Sham injection administered every month
Arm Title
Sham Group 4
Arm Type
Sham Comparator
Arm Description
Sham injection administered every other month
Intervention Type
Drug
Intervention Name(s)
ANX007
Intervention Description
Form: solution for injection; Route of Administration: IVT
Intervention Type
Other
Intervention Name(s)
Sham comparator
Intervention Description
Form and Route of Administration: pressure to mimic IVT injection
Primary Outcome Measure Information:
Title
GA lesion growth rate
Description
Change in GA lesion area as assessed by fundus autofluorescence (FAF)
Time Frame
Baseline to Month 12
Secondary Outcome Measure Information:
Title
Safety: Participants with treatment-emergent adverse events (TEAEs)
Description
Number of participants with TEAEs
Time Frame
Baseline to Month 18
Title
Best corrected visual acuity (BCVA)
Description
Change from baseline in BCVA as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) test chart
Time Frame
Baseline to Month 18
Title
Low-luminance BCVA (LL-BCVA)
Description
Change from baseline in LL-BCVA
Time Frame
Baseline to Month 18
Title
Low-luminance visual acuity deficit (LL-VD)
Description
Change from baseline in LL-VD
Time Frame
Baseline to Month 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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:
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.
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Annexon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Site 5
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Site 31
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Site 2
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Site 19
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Site 23
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
Site 37
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Site 17
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Site 18
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Site 33
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Site 39
City
Waterford
State/Province
Connecticut
ZIP/Postal Code
06385
Country
United States
Facility Name
Site 12
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
Site 53
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Site 26
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Site 16
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Site 28
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
Site 43
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Site 6
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Site 42
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Site 11
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Site 1
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Site 41
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Site 36
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Site 3
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Site 29
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Site 10
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Site 38
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
Site 9
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
Site 30
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Site 20
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Site 52
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Site 13
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Site 40
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Site 27
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Site 15
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Site 4
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Facility Name
Site 24
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Site 34
City
Burleson
State/Province
Texas
ZIP/Postal Code
76028
Country
United States
Facility Name
Site 21
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site 32
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76102
Country
United States
Facility Name
Site 22
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Site 35
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Site 54
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Site 8
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Site 14
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Site 25
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Site 49
City
Bondi Junction
State/Province
New South Wales
ZIP/Postal Code
2022
Country
Australia
Facility Name
Site 45
City
Brookvale
State/Province
New South Wales
ZIP/Postal Code
2100
Country
Australia
Facility Name
Site 46
City
Chatswood
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
Facility Name
Site 44
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Site 47
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Site 48
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Site 50
City
Christchurch
ZIP/Postal Code
8014
Country
New Zealand
Facility Name
Site 51
City
Wellington
ZIP/Postal Code
6011
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study Investigating the Efficacy and Safety of Intravitreal Injections of ANX007 in Patients With Geographic Atrophy
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