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
- Diseases
- Macular degeneration
- 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
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| University Hospitals Bristol and Weston NHS Foundation Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Frimley Health NHS Foundation Trust Coordinator of this site? Confirm its status | Frimley | United Kingdom | Unknown status |
| The Princess Alexandra Hospital Nhs Foundation Trust Coordinator of this site? Confirm its status | Harlow | United Kingdom | Unknown status |
| Moorfields Eye Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guy'S and St Thomas' Nhs Ft Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St Mary's Hospital - Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St. Mary's Hospital Coordinator of this site? Confirm its status | Newport | United Kingdom | Unknown status |
| John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Salisbury NHS Foundation Trust Coordinator of this site? Confirm its status | Salisbury | United Kingdom | Unknown status |
| University Hospital Southampton Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.