Age-Related Macular DegenerationNCT06682455
Deciphering AMD by Deep Phenotyping and Machine Learning- Prospective Study - SUMMIT (Part 2)
An observational study of Age-Related Macular Degeneration, run by University of Southampton at 8 sites in 2 countries.
Trial summary
We will conduct a prospective, non-interventional roll-over extension of the PINNACLE study (Deciphering AMD by deep phenotyping and machine learning). This will include up to 300 intermediate AMD participants (= approximately 450 untreated intermediate AMD eyes, including both unilateral (AREDS IV) and bilateral… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Age-Related Macular Degeneration
- How many people
- 300 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 12 Jun 2024to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have completed the PINNACLE study (Part 1) and have; 1) intermediate AMD in the study eye and advanced AMD in the non-study eye or 2) patients with bilateral intermediate AMD (where both eyes will be included).
Who may be able to join
- Have taken part in the PINNACLE study and progressed to/completed the final M36/V10 study visit.
- Have not been considered 'withdrawn' (either by 'opt-out', or any reason that would deem them ineligible, e.g. disease progression) from the PINNACLE study at any timepoint.
- Have a period of no longer than 12 months between their final M36/V10 PINNACLE study visit and the first SUMMIT study visit (if M36/V10 was missed, the participant will still be eligible if M32/V9 completion date is within 12 months of enrolment).
- Continued diagnosis of intermediate AMD (as defined by Ferris et al PMID: 23332590) in both eyes (i.e. large drusen > 125 µm 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 (GA or MNV secondary to AMD) in the other eye.
- Participants enrolled with both eyes (OU) on the PINNACLE study, will still be eligible to enrol under OD/OS only, should one eye have been withdrawn prior to completing PINNACLE, or considered no longer eligible during enrolment on SUMMIT.
- Have media clarity and pupillary dilation for adequate imaging and functional tests.
- Deemed able to meet the physical demands of attending 4-monthly appointments and undergo the examinations as listed in section 7.3, for the study duration (maximum 2 years).
Who cannot join
- 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).
- 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 (e.g. corneal transplant, vitreo-retinal surgery) 3 months prior or anticipated within the next 6 months following enrolment (not including cataract surgery).
- Taking drugs known to cause retinal toxicity, such as hydroxychloroquine or tamoxifen.
- OCT evidence of MNV (e.g sub-retinal scar tissue, sub-retinal fluid or intra-retinal fluid associated with a pigment epithelial detachment).
- Participants who have completed the PINNACLE study >12 months prior to their enrolment on SUMMIT.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United Kingdom7 sites
Frimley Health Nhs Foundation Trust
Frimley, Surrey, GU16 7UJ
The Princess Alexandra Hospital Nhs Foundation Trust
Harlow, Essex, CM20 1QX
Moorfields Eye Hospital
London, EC1V 2PD
St Mary's Hospital
Newport, Isle Of Wight, PO30 5TG
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Salisbury Nhs Foundation Trust
Salisbury, Wiltshire, SP2 8BJ
University Hospital Southampton
Southampton, Hampshire, SO16 6YD
About this study
We will conduct a prospective, non-interventional roll-over extension of the PINNACLE study (Deciphering AMD by deep phenotyping and machine learning). This will include up to 300 intermediate AMD participants (= approximately 450 untreated intermediate AMD eyes, including both unilateral (AREDS IV) and bilateral (≥AREDS II)). As per the PINNACLE study, SUMMIT study participants will continue to be followed using OCT imaging every 4 months for a further 2-years, to specifically investigate the morphological sequence of events preceding the conversion towards late AMD. Across both studies combined, we will be able to detect the earliest focal sites of disease progression over a total 5-year follow-up.
Read the detailed description
Participants who have taken part in the PINNACLE study and have progressed to the final visit (i.e. have not made the decision to withdraw or met any withdrawal criteria prior to completing month 36/visit 10), within 12 months of enrolment to SUMMIT will be considered for this cohort.
We will recruit patients with a continued diagnosis of 1) intermediate AMD in the study eye and advanced AMD in the non-study eye or 2) patients with bilateral intermediate AMD (where both eyes will be included).
As within PINNACLE, there will be four clinical sites performing detailed assessments on their recruited patients, and an additional eight referral sites in the United Kingdom who will follow patients by Spectral Domain Optical Coherence Tomography (SD-OCT) every 4 months. The acquired images from all sites will be sent to the Vienna Reading Centre for review.
After consent, study assessments including both structural and functional visual testing and imaging procedures, and the collection of medical and medication data will be performed at 4-monthly intervals across a maximum 2-year period. Participants will attend a maximum of 6 visits, 2 of which (M48 and M60), will be classified as 'annual' visits, where enhanced imaging and testing will take place to further identify and assess focal and global changes.
Demographic data collected as part of the PINNACLE study baseline procedures, including birth year, smoking history and body mass index data will not be re-collected as part of the SUMMIT study. The information previously collected will however be included within the SUMMIT analysis, as has also been considered previously. The data extracted from the genotyping samples within the PINNACLE study will also be included in the SUMMIT final analysis, but no additional samples or research on existing samples will be performed under the SUMMIT study protocol.
- Conditions
- Age-Related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diagnosed intermediate age-related macular degeneration | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity / specificity of OCT biomarkers
Sensitivity / specificity of OCT biomarkers identified in the retrospective branch of our study at predicting disease progression towards advanced AMD i.e. development of early onset neurosensory atrophy or choroidal neovascularisation.
Measured: 2 years
Secondary outcomes (1)
Sensitivity / specificity of novel imaging characteristics
Sensitivity / specificity of novel imaging characteristics e.g. fundus autofluorescence, AO-OCT, OCT-A at predicting disease progression; ROC curves; time from development of imaging change to development of these end-points; structure-function correlation; structure-genotype correlation; predictive risk models.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start12 Jun 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Imperial College London, Medical University of Vienna, University of Michigan, University College, London, University Hospital, Basel, Switzerland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682455
- Sponsor's protocol ID
- 256931
- Other IDs
- 47270
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests to access anonymised Individual Participant Data (IPD) can be made on application to the Trial Management Group Data Access Committee.
Publications
Futterknecht S, Riedl S, Mai J, Arabi S, Hall U, Bogunovic H, Fritsche LG, Rueckert D, Menten MJ, Sacu S, Schmidt-Erfurth U, Sivaprasad S, Lotery A, Pfau M. Lesion-Centered Functional Trajectories Reveal Early Retinal Sensitivity Decline in Intermediate AMD: PINNACLE Study Report 15. Am J Ophthalmol. 2026 Aug 17:S0002-9394(26)00467-8. doi: 10.1016/j.ajo.2026.08.017. Online ahead of print.
PubMed 42607745
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering AMD by Deep Phenotyping and Machine Learning- Prospective Study - SUMMIT (Part 2)
- ClinicalTrials.gov ID
- NCT06682455
- Acronym / sponsor ID
- 256931
- Conditions
- Age-Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- King's College London, Imperial College London, Medical University of Vienna, University of Michigan, University College, London, University Hospital, Basel, Switzerland
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will conduct a prospective, non-interventional roll-over extension of the PINNACLE study (Deciphering AMD by deep phenotyping and machine learning). This will include up to 300 intermediate AMD participants (= approximately 450 untreated intermediate AMD eyes, including both unilateral (AREDS IV) and bilateral (≥AREDS II)). As per the PINNACLE study, SUMMIT study participants will continue to be followed using OCT imaging every 4 months for a further 2-years, to specifically investigate the morphological sequence of events preceding the conversion towards late AMD. Across both studies combined, we will be able to detect the earliest focal sites of disease progression over a total 5-year follow-up.
Detailed description
Participants who have taken part in the PINNACLE study and have progressed to the final visit (i.e. have not made the decision to withdraw or met any withdrawal criteria prior to completing month 36/visit 10), within 12 months of enrolment to SUMMIT will be considered for this cohort.
We will recruit patients with a continued diagnosis of 1) intermediate AMD in the study eye and advanced AMD in the non-study eye or 2) patients with bilateral intermediate AMD (where both eyes will be included).
As within PINNACLE, there will be four clinical sites performing detailed assessments on their recruited patients, and an additional eight referral sites in the United Kingdom who will follow patients by Spectral Domain Optical Coherence Tomography (SD-OCT) every 4 months. The acquired images from all sites will be sent to the Vienna Reading Centre for review.
After consent, study assessments including both structural and functional visual testing and imaging procedures, and the collection of medical and medication data will be performed at 4-monthly intervals across a maximum 2-year period. Participants will attend a maximum of 6 visits, 2 of which (M48 and M60), will be classified as 'annual' visits, where enhanced imaging and testing will take place to further identify and assess focal and global changes.
Demographic data collected as part of the PINNACLE study baseline procedures, including birth year, smoking history and body mass index data will not be re-collected as part of the SUMMIT study. The information previously collected will however be included within the SUMMIT analysis, as has also been considered previously. The data extracted from the genotyping samples within the PINNACLE study will also be included in the SUMMIT final analysis, but no additional samples or research on existing samples will be performed under the SUMMIT study protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diagnosed intermediate age-related macular degeneration | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have completed the PINNACLE study (Part 1) and have; 1) intermediate AMD in the study eye and advanced AMD in the non-study eye or 2) patients with bilateral intermediate AMD (where both eyes will be included).
Key inclusion criteria (7 listed)
- Have taken part in the PINNACLE study and progressed to/completed the final M36/V10 study visit.
- Have not been considered 'withdrawn' (either by 'opt-out', or any reason that would deem them ineligible, e.g. disease progression) from the PINNACLE study at any timepoint.
- Have a period of no longer than 12 months between their final M36/V10 PINNACLE study visit and the first SUMMIT study visit (if M36/V10 was missed, the participant will still be eligible if M32/V9 completion date is within 12 months of enrolment).
- Continued diagnosis of intermediate AMD (as defined by Ferris et al PMID: 23332590) in both eyes (i.e. large drusen > 125 µm 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 (GA or MNV secondary to AMD) in the other eye.
- Participants enrolled with both eyes (OU) on the PINNACLE study, will still be eligible to enrol under OD/OS only, should one eye have been withdrawn prior to completing PINNACLE, or considered no longer eligible during enrolment on SUMMIT.
Key exclusion criteria (8 listed)
- 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).
- 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 (e.g. corneal transplant, vitreo-retinal surgery) 3 months prior or anticipated within the next 6 months following enrolment (not including cataract surgery).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity / specificity of OCT biomarkers
Time frame: 2 years
Sensitivity / specificity of OCT biomarkers identified in the retrospective branch of our study at predicting disease progression towards advanced AMD i.e. development of early onset neurosensory atrophy or choroidal neovascularisation.
1 secondary outcome
Sensitivity / specificity of novel imaging characteristics
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Derived from this study: PubMed 42607745Futterknecht S, Riedl S, Mai J, Arabi S, Hall U, Bogunovic H, Fritsche LG, Rueckert D, Menten MJ, Sacu S, Schmidt-Erfurth U, Sivaprasad S, Lotery A, Pfau M. Lesion-Centered Functional Trajectories Reveal Early Retinal Sensitivity Decline in Intermediate AMD: PINNACLE Study Report 15. Am J Ophthalmol. 2026 Aug 17:S0002-9394(26)00467-8. doi: 10.1016/j.ajo.2026.08.017. Online ahead of print.
- Individual participant dataSharing planned: Yes. Requests to access anonymised Individual Participant Data (IPD) can be made on application to the Trial Management Group Data Access Committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration, run by University of Southampton at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity / specificity of OCT biomarkers (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06682455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.