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Geographic AtrophyPhase 2ARCHERNCT04656561

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

A Phase 2 study testing ANX007 in people with Geographic Atrophy, run by Annexon, Inc. at 53 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Geographic Atrophy
What is being tested?
ANX007
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
270 participants
Where
53 sitesin 3 countries
Study dates
26 Feb 2021to 13 Sep 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

53 sites in 3 countries.

53 sites in 3 countries

United States45 sites

  • Site 15

    Abilene, Texas, 79606

  • Site 30

    Albuquerque, New Mexico, 87109

  • Site 20

    Asheville, North Carolina, 28803

  • Site 42

    Augusta, Georgia, 30909

  • Site 4

    Austin, Texas, 78750

  • Site 31

    Bakersfield, California, 93309

  • Site 24

    Bellaire, Texas, 77401

  • Site 2

    Beverly Hills, California, 90211

  • Site 38

    Bloomfield, New Jersey, 07003

  • Site 36

    Boston, Massachusetts, 02114

  • Site 34

    Burleson, Texas, 76028

  • Site 14

    Charlottesville, Virginia, 22903

  • Site 9

    Cherry Hill, New Jersey, 08034

  • Site 52

    Cleveland, Ohio, 44195

  • Site 21

    Dallas, Texas, 75231

  • Site 13

    Edmond, Oklahoma, 73013

  • Site 40

    Eugene, Oregon, 97401

  • Site 12

    Fort Myers, Florida, 33907

  • Site 32

    Fort Worth, Texas, 76102

  • Site 22

    Fort Worth, Texas, 76104

  • Site 1

    Hagerstown, Maryland, 21740

  • Site 41

    Hagerstown, Maryland, 21740

  • Site 53

    Jacksonville, Florida, 32216

  • Site 35

    Katy, Texas, 77494

  • Site 11

    Lexington, Kentucky, 40509

  • Site 19

    Mountain View, California, 94040

  • Site 25

    Norfolk, Virginia, 23502

  • Site 23

    Pasadena, California, 91107

  • Site 26

    Pensacola, Florida, 32503

  • Site 27

    Philadelphia, Pennsylvania, 19107

  • Site 5

    Phoenix, Arizona, 85053

  • Site 16

    Pinellas Park, Florida, 33782

  • Site 37

    Poway, California, 92064

  • Site 10

    Reno, Nevada, 89502

  • Site 29

    Royal Oak, Michigan, 48073

  • Site 17

    Sacramento, California, 95825

  • Site 54

    San Antonio, Texas, 78240

  • Site 8

    San Antonio, Texas, 78240

  • Site 18

    Santa Ana, California, 92705

  • Site 43

    Sarasota, Florida, 34233

  • Site 3

    Springfield, Massachusetts, 01107

  • Site 28

    St. Petersburg, Florida, 33711

  • Site 33

    Walnut Creek, California, 94598

  • Site 39

    Waterford, Connecticut, 06385

  • Site 6

    Winter Haven, Florida, 33880

Other trials in United States

Australia6 sites

  • Site 48

    Adelaide, South Australia, 5000

  • Site 49

    Bondi Junction, New South Wales, 2022

  • Site 45

    Brookvale, New South Wales, 2100

  • Site 46

    Chatswood, New South Wales, 2067

  • Site 44

    Sydney, New South Wales, 2000

  • Site 47

    Sydney, New South Wales, 2000

Other trials in Australia

New Zealand2 sites

  • Site 50

    Christchurch, 8014

  • Site 51

    Wellington, 6011

Other trials in New Zealand

About this study

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

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.

Being tested
ANX007, Sham comparator
Medical subject headings
Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ANX007Drug

    Form: solution for injection; Route of Administration: IVT

  • Sham comparatorOther

    Form and Route of Administration: pressure to mimic IVT injection

Study groups in NCT04656561
Study groupRoleWhat they receive
ANX007 Group 1ExperimentalANX007 administered every month
Receives: Drug: ANX007
ANX007 Group 2ExperimentalANX007 administered every other month
Receives: Drug: ANX007
Sham Group 3Sham comparatorSham injection administered every month
Receives: Other: Sham comparator
Sham Group 4Sham comparatorSham injection administered every other month
Receives: Other: Sham comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Change (Slope) From Baseline to Month 12 in GA Lesion Area

    GA lesion area was assessed by fundus autofluorescence (FAF) imaging, by an independent central reading center for GA lesion area. A linear mixed effect (LME) model was used to analyze the rate of change from baseline to Month 12 GA lesion area (mm2) for all groups. The model included fixed effects of treatment, time point, treatment by time point interaction, baseline GA lesion area, baseline GA lesion area by timepoint interaction, and baseline lesion multifocality. A random intercept for participant ID and a random slope for timepoint are included to account for repeated measurements for participants. The GA lesion area was analyzed as reported (that is, not transformed).

    Measured: Baseline to Month 12

Secondary outcomes (8)

  1. Change From Baseline to Month 12 in GA Lesion Area

    GA lesion area was assessed by fundus autofluorescence (FAF) imaging, by an independent central reading center for GA lesion area.

    Measured: Baseline to Month 12

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the investigational medicinal product. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse events module.

    Measured: Baseline to Month 12

  3. Change From Baseline to Month 12 in Best Corrected Visual Acuity (BCVA)

    BCVA was assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score on a test chart at a starting distance of 4 meters at each study visit. BCVA scores range from 0 to 100 letters with a higher score indicating a better vision.

    Measured: Baseline to Month 12

  4. Number of Events With Confirmed ≥ 15-Letter Loss BCVA Decline

    Confirmed ETDRS BCVA ≥15-letter loss was defined as ≥15-letter loss observed for 2 consecutive visits. BCVA was assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score on a test chart at a starting distance of 4 meters at each study visit. BCVA scores range from 0 to 100 letters with a higher score indicating a better vision.

    Measured: Baseline to Month 12

  5. Change From Baseline to Month 12 in LLVA

    LLVA was assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score on a test chart at a starting distance of 4 meters at each study visit. BCVA scores range from 0 to 100 letters with a higher score indicating a better vision.

    Measured: Baseline to Month 12

  6. Number of Events With ≥ 15-Letter Loss LLVA Decline

    LLVA ≥15-letter loss worsening from Baseline during the 12-month Treatment. LLVA was assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score on a test chart at a starting distance of 4 meters at each study visit. BCVA scores range from 0 to 100 letters with a higher score indicating a better vision.

    Measured: Baseline to Month 12

  7. Change From Baseline to Month 12 in LLVD

    LLVD as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score on a test chart at a starting distance f 4 meters at each study visit. LL-VD will be derived by subtracting LL-BCVA from BCVA.

    Measured: Baseline to Month 12

  8. Number of Events With ≥ 15-Letter Loss LLVD Decline

    LLVD ≥15-letter loss worsening from Baseline during the 12-month Treatment. LLVD was assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score on a test chart at a starting distance of 4 meters at each study visit. BCVA scores range from 0 to 100 letters with a higher score indicating a better vision.

    Measured: Baseline to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2020
  2. Study start26 Feb 2021
  3. Primary completion28 Mar 2023
  4. Study completion13 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04656561
Sponsor's protocol ID
ANX007-GA-01
Acronym
ARCHER
Status last verified
Sep 2026
First submitted
1 Dec 2020
Last updated
21 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.

    PubMed 37314061

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ANX007 in people with Geographic Atrophy, run by Annexon, Inc. at 53 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Change (Slope) From Baseline to Month 12 in GA Lesion Area (time frame: Baseline to Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04656561, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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