An open-label multiple dose safety, tolerability and exploratory efficacy clinical trial of PST-611 in patients with geographic atrophy secondary to age-related macular degeneration

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-525008-12-00

Enrollment

Registered

2026-06-25

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-25

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

• Ocular AEs and TEAEs (incl. SAEs) frequency and severity. • Findings at ophthalmic clinical examination, including slit lamp biomicroscopy and dilated ophthalmoscopy, intraocular pressure (IOP) and best corrected visual acuity (BCVA), color fundus photography (CFP) and Spectral Domain-Optical Coherence Tomography (SD-OCT).

Detailed description

• Change from Baseline (CFB) in Intraocular pressure (IOP) • CFB in ophthalmic clinical examination including slit lamp biomicroscopy and ophthalmoscopy • CFB in clinical assessment of color fundus photography (CFP) • CFB in clinical assessment of Spectral Domain-Optical Coherence Tomography (SD-OCT, CFB in best corrected visual acuity (BCVA), CFB in quantitative Contrast Sensitivity Function (qCSF) at normal luminance (Manifold Platform®) CFB in the area of retinal pigment epithelium (RPE) loss identified by deep learning-based analysis of SD-OCT CFB in the area of photoreceptor (PR) degeneration (also known as EZ layer loss) identified by deep learning-based analysis of SD-OCT

Interventions

None listed

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Ocular AEs and TEAEs (incl. SAEs) frequency and severity. • Findings at ophthalmic clinical examination, including slit lamp biomicroscopy and dilated ophthalmoscopy, intraocular pressure (IOP) and best corrected visual acuity (BCVA), color fundus photography (CFP) and Spectral Domain-Optical Coherence Tomography (SD-OCT).	—

Secondary

Measure	Time frame
• Change from Baseline (CFB) in Intraocular pressure (IOP) • CFB in ophthalmic clinical examination including slit lamp biomicroscopy and ophthalmoscopy • CFB in clinical assessment of color fundus photography (CFP) • CFB in clinical assessment of Spectral Domain-Optical Coherence Tomography (SD-OCT, CFB in best corrected visual acuity (BCVA), CFB in quantitative Contrast Sensitivity Function (qCSF) at normal luminance (Manifold Platform®) CFB in the area of retinal pigment epithelium (RPE) loss identified by deep learning-based analysis of SD-OCT CFB in the area of photoreceptor (PR) degeneration (also known as EZ layer loss) identified by deep learning-based analysis of SD-OCT	—

Measure

Time frame

—

Outcome results