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A Phase 2, Randomized, Masked, Placebo-Controlled Study of Subcutaneously Administered ADX-038 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521779-30-00
Enrollment
32
Registered
2026-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-18

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

Conditions

Geographic atrophy secondary to age-related macular degeneration

Brief summary

Slope of change in GA area (square root transformation) as measured by FAF from baseline to Month 12 (expressed in mm/year) in the study eye

Detailed description

Slope of change in GA area (square root transformation) as measured by FAF from baseline to Month 24 (expressed in mm/year) in the study eye; Rate of change in the macular area of photoreceptor loss (defined as an EZ-RPE thickness of 0 μm) assessed by OCT and EZ mapping at Month 12 and Month 24, Proportion of participants with ≥15 letter loss in ETDRS letters in the study eye at 2 consecutive visits or EOS Visit

Interventions

DRUGSodio cloruro Galenica Senese 0
DRUG9% solvente per uso parenterale

Sponsors

Adarx Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Slope of change in GA area (square root transformation) as measured by FAF from baseline to Month 12 (expressed in mm/year) in the study eye

Secondary

MeasureTime frame
Slope of change in GA area (square root transformation) as measured by FAF from baseline to Month 24 (expressed in mm/year) in the study eye; Rate of change in the macular area of photoreceptor loss (defined as an EZ-RPE thickness of 0 μm) assessed by OCT and EZ mapping at Month 12 and Month 24, Proportion of participants with ≥15 letter loss in ETDRS letters in the study eye at 2 consecutive visits or EOS Visit

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 19, 2026