NCT04269304

Brief Summary

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
429

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
3 countries

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

5.6 years

First QC Date

February 11, 2020

Last Update Submit

November 7, 2024

Conditions

Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Sensitivity / specificity of OCT and autofluorescence parameters.

    Identified by machine learning (ML) at predicting disease progression defined as focal conversion towards advanced AMD e.g. change in drusen volume, development of new geographic atrophy / choroidal neovascularisation.

    3 years

Secondary Outcomes (1)

  • Sensitivity / specificity of novel imaging characteristics

    3 years

Study Arms (1)

Observational

Intermediate Age-Related Macular Degeneration Patients

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with 1) intermediate AMD in one eye and advanced AMD in the non-study eye or 2) patients with bilateral intermediate AMD (where both eyes will be included).

You may qualify if:

  • 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.

You may not qualify if:

  • Co-existent ocular disease, which might affect visual function or retinal morphology
  • Cataract sufficient to affect retinal imaging
  • Myopia \> minus 6 diopters or a history of myopia \> minus 6 diopters if patient has had cataract / refractive surgery.
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Medical University of Vienna

Vienna, 1090, Austria

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

The Princess Alexandra Hospital Nhs Foundation Trust

Harlow, Essex, CM20 1QX, United Kingdom

Location

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

St Mary's Hospital

Newport, Isle Of Wight, PO30 5TG, United Kingdom

Location

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Frimley Health Nhs Foundation Trust

Frimley, Surrey, GU16 7UJ, United Kingdom

Location

Salisbury Nhs Foundation Trust

Salisbury, Wiltshire, SP2 8BJ, United Kingdom

Location

University Hospitals Bristol and Weston Nhs Foundation Trust

Bristol, BS1 3NU, United Kingdom

Location

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

Guy'S and St Thomas' Nhs Ft

London, SE1 9RT, United Kingdom

Location

St Mary's Hospital, Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Related Publications (1)

  • Anders P, Traber GL, Pfau M, Riedl S, Hagag AM, Camenzind H, Mai J, Kaye R, Bogunovic H, Fritsche LG, Rueckert D, Schmidt-Erfurth U, Sivaprasad S, Lotery AJ, Scholl HPN. Comparison of Novel Volumetric Microperimetry Metrics in Intermediate Age-Related Macular Degeneration: PINNACLE Study Report 3. Transl Vis Sci Technol. 2023 Aug 1;12(8):21. doi: 10.1167/tvst.12.8.21.

    PMID: 37624605DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

DNA for genotype analysis.

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Andrew J Lotery, Prof

    University of Southampton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 13, 2020

Study Start

October 28, 2019

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Requests to access anonymised Individual Participant Data (IPD) can be made on application to the Trial Management Group Data Access Committee.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Currently available and can be accessed indefinitely.
Access Criteria
Requests for further information such as a clinical study report will be considered by the investigators following the end of the study and publication of primary outputs.
More information

Locations

GB(10)CH(1)AU(1)