← Back to the studies fieldPERMANENT CTIS TRIAL DOSSIER

2025-525008-12-00

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

Public registry stateAuthorised

CLAIM BOUNDARY

This dossier documents a medicinal trial—not proof of efficacy.

Registration, authorisation of a trial application, trial start, result disclosure and marketing authorisation are different facts. The dossier claims neither clinical efficacy nor safety, deployment or causality.

CTIS record ≠ efficacy ≠ marketing authorisation

REGISTRY FACTS

What CTIS publishes about this trial

EUCT number: 2025-525008-12-00
Trial status: Authorised
Sponsor: not published
Trial region: EEA
Phase: 4
Trial category: 2
Low-intervention trial: no
Estimated EU start: 01 September 2026
Decision date: 25 June 2026
Published: 26 June 2026
Estimated end: 30 June 2028

EXACT AI EVIDENCE

The original text determines inclusion.

Terms count only in allowlisted public CTIS fields. Sponsor, medical condition, phase or a generic software reference alone is not AI evidence.

“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”

Source field: authorizedApplication.authorizedPartI.trialDetails.trialInformation.endPoint.secondaryEndPoints[2].endPoint
Matched term: deep learning

MEDICAL CONTEXT

Conditions and therapeutic areas

Reported medical conditions

Geographic atrophy secondary to age-related macular degeneration

Therapeutic areas

Diseases [C] - Eye Diseases [C11]11

COUNTRY TRACKS

Every country retains its own published state.

A status in one country is not transferred to another. Decision dates and status histories remain separate source facts.

France

Authorised

First decision: 25 June 2026
Latest decision: 25 June 2026

25 June 2026Authorised
25 June 2026Authorised

TRIAL APPLICATIONS

Submission, decision and country state remain separate

INITIAL

Authorised

Trial status: Authorised
Submitted: 19 March 2026
Decided: 25 June 2026

Decisions25 June 2026 · Authorized Conditions

Country statusFrance · Authorised

SOURCE-DATED CHRONICLE

Official dates, not an efficacy narrative.

The chronicle sorts published CTIS events. i6eal observation times follow on a separate clock.

19 March 2026Application Submitted
Application IN · Authorised
22 June 2026Country Assessment
France · Application IN · Authorized Conditions
25 June 2026Application Status
Application IN · Authorised
25 June 2026Country Decision
France · Application IN · Authorized Conditions
23 July 2026Trial Status Observed
Authorised

Observed by i6eal

First observed: 23 Jul 2026, 13:19
Last observed: 23 Jul 2026, 15:03
Materially modified: 23 July 2026

RESULT DISCLOSURE

Disclosure is a separate registry fact.

No result disclosure is published in this projection. This means neither that results do not exist nor that a deadline has been missed.

PROVENANCE

From the dossier back to the official record

The public CTIS record remains authoritative. The i6eal files are a deterministic, bounded projection.

Open public CTIS record ↗Open CTIS retrieval source ↗Machine-readable dossier · JSON ↓Structured metadata · JSON-LD ↓

i6eal (2026): EU AI Studies Monitor, CTIS trial 2025-525008-12-00, data state 23 July 2026. https://i6eal.de/en/tools/ki-studienmonitor/studie/2025-525008-12-00/