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NCT04269304Active, not recruiting

Deciphering AMD by Deep Phenotyping and Machine Learning- Prospective Study - PINNACLE

Source: ClinicalTrials.gov · Last updated 12 Nov 2024

Brief summary (registry, in English)

We will conduct a prospective non-interventional study including 400 early AMD patients (=600 untreated early AMD eyes, including both unilateral (AREDS IV) and bilateral (≥AREDS II)) over a minimum of 1 year to specifically investigate the morphological sequence of events preceding the conversion towards late AMD. All patients will be followed by Optical Coherence Tomography (OCT) imaging every 4 months to detect the earliest focal sites of disease progression. As soon as focal areas of change are observed by the Vienna Reading Center (VRC), a targeted follow-up schedule will be triggered to investigate the events at that area of change in a targeted manner.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
429 (actual)
First submitted
11 Feb 2020
Start date
28 Oct 2019
Primary completion date
Jun 2025
Lead sponsor
University of Southampton
NCT number
NCT04269304

What you commit to

  • Study type: Observational
  • Participants enrolled: 429
  • From 28 Oct 2019 to the primary completion date, Jun 2025
  • 12 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Major ocular surgery 3 months prior or anticipated within the next 6 months following enrolment.
  • Taking drugs known to cause retinal toxicity such as hydroxychloroquine or tamoxifen

Other illness

  • Co-existent ocular disease, which might affect visual function or retinal morphology
  • Established glaucoma in either study eye or fellow eye with evidence of visual field loss or retinal nerve fibre loss (ocular hypertension is not an exclusion criterion unless associated with visual field loss or retinal nerve fibre loss in either eye).
  • Myopia \> minus 6 diopters or a history of myopia \> minus 6 diopters if patient has had cataract / refractive surgery.

Other

  • Cataract sufficient to affect retinal imaging
  • OCT evidence of geographic atrophy (or complete Retinal Pigment Epithelium (RPE) and outer retinal atrophy (cRORA). This is (1) a region of hypertransmission of at least 250 mm in diameter, (2) a zone of attenuation or disruption of the RPE of at least 250 mm in diameter, (3) evidence of overlying photoreceptor degeneration, and (4) absence of scrolled RPE or other signs of an RPE tear.
  • OCT evidence of choroidal neovascularization e.g sub-retinal scar tissue, sub-retinal fluid or intra-retinal fluid associated with a pigment epithelial detachment

Who the study is looking for

  • Subjects ≥ 55 years with either intermediate AMD (as defined by Ferris et al PMID: 23332590) in both eyes, i.e. large drusen \> 125 um and/or any definite hyper- or hypopigmentary abnormalities associated with medium or large drusen; or intermediate AMD as defined above in one eye (study eye) and advanced AMD (geographic atrophy or choroidal neovascularization secondary to AMD) in the other eye.
  • Subjects should have media clarity and pupillary dilation for adequate imaging and functional tests.

Age in the registry: 55 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Vienna
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ViennaAustriaUnknown status
University Hospital Basel
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BaselSwitzerlandUnknown status
University Hospitals Bristol and Weston NHS Foundation Trust
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BristolUnited KingdomUnknown status
Frimley Health NHS Foundation Trust
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FrimleyUnited KingdomUnknown status
The Princess Alexandra Hospital Nhs Foundation Trust
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HarlowUnited KingdomUnknown status
Moorfields Eye Hospital
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LondonUnited KingdomUnknown status
Guy'S and St Thomas' Nhs Ft
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LondonUnited KingdomUnknown status
St Mary's Hospital - Imperial College Healthcare NHS Trust
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LondonUnited KingdomUnknown status
St. Mary's Hospital
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NewportUnited KingdomUnknown status
John Radcliffe Hospital
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OxfordUnited KingdomUnknown status
Salisbury NHS Foundation Trust
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SalisburyUnited KingdomUnknown status
University Hospital Southampton
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SouthamptonUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.