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

Sponsor
Annexon, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04656561
Collaborator
(none)
270
Enrollment
53
Locations
4
Arms
34.1
Anticipated Duration (Months)
5.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
270 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 26, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ANX007 Group 1

ANX007 administered every month

Drug: ANX007
Form: solution for injection; Route of Administration: IVT
Experimental: ANX007 Group 2

ANX007 administered every other month

Drug: ANX007
Form: solution for injection; Route of Administration: IVT
Sham Comparator: Sham Group 3

Sham injection administered every month

Other: Sham comparator
Form and Route of Administration: pressure to mimic IVT injection
Sham Comparator: Sham Group 4

Sham injection administered every other month

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

Outcome Measures

Primary Outcome Measures

  1. GA lesion growth rate [Baseline to Month 12]

    Change in GA lesion area as assessed by fundus autofluorescence (FAF)

Secondary Outcome Measures

  1. Safety: Participants with treatment-emergent adverse events (TEAEs) [Baseline to Month 18]

    Number of participants with TEAEs

  2. Best corrected visual acuity (BCVA) [Baseline to Month 18]

    Change from baseline in BCVA as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) test chart

  3. Low-luminance BCVA (LL-BCVA) [Baseline to Month 18]

    Change from baseline in LL-BCVA

  4. Low-luminance visual acuity deficit (LL-VD) [Baseline to Month 18]

    Change from baseline in LL-VD

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 (mm2) and ≤17.5 mm2.

  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Site 5 Phoenix Arizona United States 85053
2 Site 31 Bakersfield California United States 93309
3 Site 2 Beverly Hills California United States 90211
4 Site 19 Mountain View California United States 94040
5 Site 23 Pasadena California United States 91107
6 Site 37 Poway California United States 92064
7 Site 17 Sacramento California United States 95825
8 Site 18 Santa Ana California United States 92705
9 Site 33 Walnut Creek California United States 94598
10 Site 39 Waterford Connecticut United States 06385
11 Site 12 Fort Myers Florida United States 33907
12 Site 53 Jacksonville Florida United States 32216
13 Site 26 Pensacola Florida United States 32503
14 Site 16 Pinellas Park Florida United States 33782
15 Site 28 Saint Petersburg Florida United States 33711
16 Site 43 Sarasota Florida United States 34233
17 Site 6 Winter Haven Florida United States 33880
18 Site 42 Augusta Georgia United States 30909
19 Site 11 Lexington Kentucky United States 40509
20 Site 1 Hagerstown Maryland United States 21740
21 Site 41 Hagerstown Maryland United States 21740
22 Site 36 Boston Massachusetts United States 02114
23 Site 3 Springfield Massachusetts United States 01107
24 Site 29 Royal Oak Michigan United States 48073
25 Site 10 Reno Nevada United States 89502
26 Site 38 Bloomfield New Jersey United States 07003
27 Site 9 Cherry Hill New Jersey United States 08034
28 Site 30 Albuquerque New Mexico United States 87109
29 Site 20 Asheville North Carolina United States 28803
30 Site 52 Cleveland Ohio United States 44195
31 Site 13 Edmond Oklahoma United States 73013
32 Site 40 Eugene Oregon United States 97401
33 Site 27 Philadelphia Pennsylvania United States 19107
34 Site 15 Abilene Texas United States 79606
35 Site 4 Austin Texas United States 78750
36 Site 24 Bellaire Texas United States 77401
37 Site 34 Burleson Texas United States 76028
38 Site 21 Dallas Texas United States 75231
39 Site 32 Fort Worth Texas United States 76102
40 Site 22 Fort Worth Texas United States 76104
41 Site 35 Katy Texas United States 77494
42 Site 54 San Antonio Texas United States 78240
43 Site 8 San Antonio Texas United States 78240
44 Site 14 Charlottesville Virginia United States 22903
45 Site 25 Norfolk Virginia United States 23502
46 Site 49 Bondi Junction New South Wales Australia 2022
47 Site 45 Brookvale New South Wales Australia 2100
48 Site 46 Chatswood New South Wales Australia 2067
49 Site 44 Sydney New South Wales Australia 2000
50 Site 47 Sydney New South Wales Australia 2000
51 Site 48 Adelaide South Australia Australia 5000
52 Site 50 Christchurch New Zealand 8014
53 Site 51 Wellington New Zealand 6011

Sponsors and Collaborators

  • Annexon, Inc.

Investigators

  • Study Director: Clinical Trials, Annexon, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Annexon, Inc.
ClinicalTrials.gov Identifier:
NCT04656561
Other Study ID Numbers:
  • ANX007-GA-01
First Posted:
Dec 7, 2020
Last Update Posted:
Jul 5, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Geographic Atrophy
Atrophy

Study Results

No Results Posted as of Jul 5, 2022