Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06510816 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA)

Study acronym: ARCHER II
StatusActive, Not Recruiting
PhasePhase 3
Started2024-07-30
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Oct 31, 2026 → Jul 31, 2027
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Annexon, Inc.

Amendment history

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
2026-10-02
Primary endpoint(s) modified1 to 2 entries
WasProportion of Participants Experiencing a Best Corrected Visual Acuity (BCVA) ≥15-letter Loss from Baseline Through Month 15 as Assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Any Two Consecutive Visits
NowProportion of Participants Experiencing a BCVA ≥15-letter Loss from Baseline Through Month 24 as Assessed by the ETDRS Chart at Any Two Consecutive Visits, Proportion of Participants Experiencing a Best Corrected Visual Acuity (BCVA) ≥15-letter Loss from Baseline Through Month 15 as Assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Any Two Consecutive Visits
Primary completion pushed: 2026-10-31 → 2027-07-31
Eligibility criteria+4 characters
Inclusion Criteria: * Diagnosis of dry AMD with GA as determined by the Investigat [...] the independent Central Reading Center. Exclusion Criteria: * Geographic atrophy due to other causes than AMD such as Star [...]
Secondary endpoints4 to 3 entries
Proportion of Participants Experiencing a Confirmed BCVA ≥15-letter Loss
Study sitesdetails revised at 5 of 132 sites
2026-04-28
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v11
Completion date2027-10-31→2027-07-31
Study sites130→132
Eligibility criteria-22 characters
Inclusion Criteria: Diagnosis of GA of the macula secondary todry AMD with GA as determined by the Investigator and confirmed by the inde [...] TE: Other protocol-defined inclusion and exclusion criteria may apply.
Secondary endpoints1 to 4 entries
Time to Confirmed BCVA ≥15-letter Loss Proportion of Participants Experiencing a Confirmed BCVA ≥15-letter Loss Proportion of Participants with Low-luminance BCVA (LLVA) ≥15-letter Loss Change Fromfrom Baseline in the HazardArea of ≥15 letter BCVATotal Loss Throughof Monththe 12Ellipsoid andZone Month(EZ) 24Layer
Primary endpoints1 entry, revised
Proportion of patientsParticipants experiencingExperiencing a bestBest correctedCorrected visualVisual acuityAcuity (BCVA) ≥15-letter lossLoss from baselineBaseline throughThrough theMonth primary timepoint15 as assessedAssessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chartChart at anyAny twoTwo consecutiveConsecutive visits.Visits
Study title+48 characters
[...] tions of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA)
2025-11-05
Recruiting→Active, Not Recruiting Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Contacts/Locations, IPDSharing v10
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 630→confirmed 659
Study sites117→130
InterventionsANX007 (Drug), Sham Administration (Other)→Sham Administration (Other), Vonaprument (Drug)
Study title+23 characters
A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Geographic Atrophy (GA)
2025-05-08
Study Status, Contacts/Locations v9
Study sites105→117
2025-04-11
Study Status, Contacts/Locations v8
Study sites87→105
Show 6 earlier versions
2025-03-24
Study Status, Contacts/Locations v7
Study sites82→87
2025-03-05
Study Status, Contacts/Locations v6
Study sites77→82
2025-02-07
Study Status, Contacts/Locations v5
Study sites49→77
2024-12-02
Study Status, Contacts/Locations v4
Study sites37→49
2024-11-01
Study Status, Outcome Measures, Contacts/Locations v3
Primary completion date2026-10→2026-10-31
Completion date2027-10→2027-10-31
Study sites13→37
Primary endpoints1 entry, revised
[...] etinopathy Study (ETDRS) chart at any two consecutive visits.
2024-08-30
Not Yet Recruiting→Recruiting Study Status, Oversight, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-07→confirmed 2024-07-30
Study sites0→13
Primary endpoints1 entry, revised
[...] etinopathy Study (ETDRS) chart at any two consecutive visits.
2024-07-15
Original filing
Annexon, Inc.
5 trials monitored
See 1 trial at risk
The primary purpose of the study is to determine if IVT injections of vonaprument every month reduce vision loss in participants with dry AMD with GA.
Trial Details
NCT Number NCT06510816
Lead Sponsor Annexon, Inc.
Conditions Geographic Atrophy
Enrollment 659 participants
Start Date 2024-07-30
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-10-06