{
  "id": "ctis:2025-525008-12-00",
  "euct": "2025-525008-12-00",
  "title": "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",
  "publicTitle": "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",
  "fullTitle": "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",
  "shortTitle": "PST-611-CT2",
  "status": "Authorised",
  "statusCode": "2",
  "startDateEU": null,
  "decisionDate": "2026-06-25T12:59:00.891",
  "publishDate": "2026-06-26T03:39:08.668966418",
  "trialRegion": "EEA",
  "trialRegionCode": "1",
  "medicalConditions": [
    {
      "name": "Geographic atrophy secondary to age-related macular degeneration",
      "rareDisease": false
    }
  ],
  "therapeuticAreas": [
    {
      "code": "11",
      "name": "Diseases [C] - Eye Diseases [C11]"
    }
  ],
  "trialCategory": {
    "phaseCode": "4",
    "categoryCode": "2",
    "lowIntervention": false
  },
  "duration": {
    "estimatedRecruitmentStartDate": "2026-09-01",
    "estimatedEndDate": "2028-06-30",
    "estimatedGlobalEndDate": null
  },
  "countries": [
    {
      "name": "France",
      "publicStatusCode": "2",
      "firstDecisionDate": "2026-06-25T12:59:00.891",
      "lastDecisionDate": "2026-06-25T12:59:00.891",
      "history": [
        {
          "source": "application_country_status",
          "applicationBusinessKey": "IN",
          "applicationType": "INITIAL",
          "status": "Authorised",
          "trialStatus": "Authorised",
          "decision": "authorized_conditions",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2026-06-22",
          "date": "2026-06-25",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        },
        {
          "source": "application_decision",
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          "applicationType": "INITIAL",
          "status": "Authorised",
          "trialStatus": "Authorised",
          "decision": "authorized_conditions",
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          "date": "2026-06-25T12:59:00.891",
          "isRMS": true
        }
      ]
    }
  ],
  "applications": [
    {
      "id": "application:2025-525008-12-00:in",
      "businessKey": "IN",
      "type": "INITIAL",
      "status": "Authorised",
      "trialStatus": "Authorised",
      "submissionDate": "2026-03-19",
      "decisionDate": "2026-06-25",
      "decisions": [
        {
          "mscName": "France",
          "decisionDate": "2026-06-25T12:59:00.891",
          "decision": "authorized_conditions",
          "assessmentOutcome": "acceptable",
          "eventType": "decision",
          "applicationType": "INITIAL",
          "isRMS": true
        }
      ],
      "countryStatuses": [
        {
          "countryName": "France",
          "mscName": "France",
          "trialStatus": "Authorised",
          "decision": "authorized_conditions",
          "decisionDate": "2026-06-25",
          "firstDecisionDate": "2026-06-25",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2026-06-22",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        }
      ]
    }
  ],
  "evidence": [
    {
      "id": "evidence:3c4a4c1b47c2fe0ca6df2186",
      "path": "authorizedApplication.authorizedPartI.trialDetails.trialInformation.endPoint.secondaryEndPoints[2].endPoint",
      "term": "deep learning",
      "snippet": "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"
    }
  ],
  "official": {
    "retrieveUrl": "https://euclinicaltrials.eu/ctis-public-api/retrieve/2025-525008-12-00",
    "publicUrl": "https://euclinicaltrials.eu/ctis-public/view/2025-525008-12-00?lang=en"
  },
  "slug": "2025-525008-12-00",
  "firstObservedAt": "2026-07-23T11:19:41.794Z",
  "lastObservedAt": "2026-07-23T13:03:56.000Z",
  "dateModified": "2026-07-23",
  "materialFingerprint": "8be4c96e1e007ca74f5f71868bf5dfef55ab1864e20a226f3b2b428139133b1f"
}