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A Phase 3, Multicenter, Randomized, Parallel-Group, Double-Masked, 2-Arm, Sham Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 Administered by Intravitreal Injection in Participants with Dry Age-Related Macular Degeneration with Geographic Atrophy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515022-88-00
Acronym
ANX007-GA-02
Enrollment
125
Registered
2025-02-10
Start date
2025-03-03
Completion date
Unknown
Last updated
2025-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Age-Related Macular Degeneration (AMD) with geographic atrophy (GA)

Brief summary

Confirmed best corrected visual acuity (BCVA) ≥15-letter loss from baseline through the primary timepoint as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) method. The primary timepoint is based on accumulation of the target event rate, but no earlier than Month 12 and no later than Month 18, French translation continuation

Detailed description

Incidence and severity of ocular and systemic treatment-emergent adverse events (TEAEs)

Interventions

DRUGANX007

Sponsors

Annexon Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Confirmed best corrected visual acuity (BCVA) ≥15-letter loss from baseline through the primary timepoint as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) method. The primary timepoint is based on accumulation of the target event rate, but no earlier than Month 12 and no later than Month 18, French translation continuation

Secondary

MeasureTime frame
Incidence and severity of ocular and systemic treatment-emergent adverse events (TEAEs)

Countries

Austria, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026