Age-Related Macular DegenerationAPENNINESNCT06351657
Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression
An observational study of Age-Related Macular Degeneration and Geographic Atrophy, run by Medical University of Vienna at 7 sites in 6 countries.
Trial summary
The goal of this prospective, multinational, multicenter observational study is to assess and predict progression in non-foveal, non-vision compromising atrophic AMD on an individual-based level over two years. Read more about this study
- Who is it for?
- Ages 55 to 99 years
- Conditions the study is for
- Age-Related Macular Degeneration, Geographic Atrophy
- How many people
- 200 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 11 Apr 2025to Jul 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 55 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from each center's respective outpatient clinic and/or by referral from primary eye care (e.g. optometrist).
Who may be able to join
- Age: 55-99 years old
- Complete RPE and outer retinal atrophy (cRORA). This is (1) a region of hypertransmission of at least 250 µm in diameter, (2) a zone of attenuation or disruption of the RPE of at least 250 µm in diameter, (3) evidence of overlying photoreceptor degeneration, and (4) absence of scrolled RPE or other signs of an RPE tear.
- If both eyes are eligible, both eyes will be included in the cohort study.
- Clear optical media and adequate pupillary dilation for imaging and functional testin
Who cannot join
- Any surgical treatment of the eye within 3 months prior to baseline in the study eye
- History of anti-VEGF treatment in the study eye before baseline
- History of pseudophakic cystoid macular edema (Irvine Gass Syndrome) in the study eye
- History of uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg despite treatment with IOP lowering medication), or C/D Ratio > 0.9
- Any concurrent intraocular condition in the study eye (e.g. advanced cataract or moderate/severe diabetic retinopathy) that, in the opinion of the investigator, will most likely require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition
- Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could cause an unwanted effect on treatment efficacy, compliance or require intraocular surgery (except for cataract surgery and YAG capsulotomy) during the study period
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- Presence of corneal decompensation, haze or scarring with an impact on BCVA
- Refractive error larger than 6 diopters. In case of pseudophakia or refractive surgery: History of refractive error larger than 6 diopters.
- Intake of drugs known to cause retinal toxicity (e.g. hydroxychloroquine or tamoxifen)
- Presence of active macular neovascularization at baseline.
Trial locations and contacts
7 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 6 countries
Switzerland2 sites, 2 recruiting
- Recruiting
Vista Klinik Binningen
Binningen
Katja Hatz, +41614266079, Katja.Hatz@vista.ch
- Recruiting
University of Zürich
Zurich
Daniel Barthelmes, +41432530598, Daniel.Barthelmes@usz.ch
Austria1 site, 1 recruiting
- Not yet recruiting
Medical University of Vienna
Vienna
Gregor S Reiter, Priv.-Doz. Ing. DDr., BA MSc, +4314040073419, gregor.reiter@meduniwien.ac.at
France1 site, 1 recruiting
- Recruiting
CHU Dijon
Dijon
Catherine Creuzot-Garcher, MD, +33380293756, catherine.creuzot-garcher@chu-dijon.fr
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Center Ljubljana
Ljubljana
Polona Jaki-Mekjavic, MD, +38615221900, polona.jakimekjavic@kclj.si
Spain1 site, 1 recruiting
- Recruiting
Fundacio de Recerca Clinic Barcelona-Institut D Investigacions Biomed
Barcelona
Javier Zarranz-Ventura, +34617926250, zarranz@clinic.cat
United Kingdom1 site, 1 recruiting
- Recruiting
Queen's Unviversity Belfast
Belfast
Ruth Hogg, +447734671087, r.e.hogg@qub.ac.uk
About this study
Official title: Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression in a Prospective, Multinational, Multicenter Observational Study
The goal of this prospective, multinational, multicenter observational study is to assess and predict progression in non-foveal, non-vision compromising atrophic AMD on an individual-based level over two years. The main objectives of this study are:
- Assess the individual progression rate of a patient in non-foveal, non-vision compromising atrophic AMD and assess personalized risk of progression based on imaging.
- Identify and quantify focal and global alterations in the retina in regard to disease progression.
- Evaluate the monitoring of AMD progression using approved AI algorithms.
Read more
All patients will be followed for 24 months with 6 month intervals to assess clinical changes. Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures:
- Scanning Laser Fundus Photography
- Color Fundus Photography (CFP)
- Optical Coherence Tomography (OCT)
- Optical Coherence Tomography Angiography (OCTA)
Patients will be asked for their medical history. Standard ophthalmic examination, as well as a questionnaire on visual function will be carried out.
No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label.
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for fast geographic atrophy (GA) progression
The association between biomarkers and GA progression will be assessed by linear mixed models. Artificial intelligence models will be applied to assess progression speed and predict local and global progression.
Mixed Effects models will be calculated to estimate the association between the above mentioned independent variables, including the timepoint as an independent variable, on individual markers of progression (RPE and PR thinning).
The r-squared value of the predicted increase in atrophy area will be used as an endpoint assessment to evaluate the predictive model.
Measured: 2 years
Secondary outcomes (2)
To identify and quantify disease progression-related biomarkers
Longitudinal assessments of imaging biomarkers are performed in a descriptive manner. The following biomarkers will be evaluated in detail as independent variables:
- Hyperreflective Foci (HRF) (scale, nL)
- Drusen volume/Refractile drusen (scale, nL)
- Subretinal Drusenoid Deposits (SDD) (scale, mm2)
- PR loss/RPE loss ratio (scale, ratio)
- GA lesion size (mm2)
- Foveal involvement (categorical; yes or no)
- Thinning of outer retinal layers (PR thinning) (scale, µm)
- Other retinal biomarkers if relevant to the progression of GA
The association between biomarkers and GA progression will be assessed by linear mixed models.
Measured: 2 years
To evaluate monitoring AMD progression using approved AI algorithms.
The following will be provided by AI-based image analysis of the GA Monitor (independent variables):
- RPE integrity loss (mm2) in the 1mm central area, 6mm area, and the respective relative change to previous visit
- PR integrity loss (mm2) in the 1mm central area, 6mm area, and the respective relative change to previous visit
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 posted8 Apr 2024
- Study start11 Apr 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Centre Ljubljana, Centre Hospitalier Universitaire Dijon, University of Zurich, Vista Klinik, Queen's University, Belfast, Fundacion Clinic per a la Recerca Biomédica
- Responsible party
- Principal investigator, Gregor Reiter, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351657
- Sponsor's protocol ID
- 1088/2024
- Acronym
- APENNINES
- Status last verified
- May 2025
- First submitted
- 2 Apr 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression in a Prospective, Multinational, Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT06351657
- Acronym / sponsor ID
- APENNINES / 1088/2024
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- University Medical Centre Ljubljana, Centre Hospitalier Universitaire Dijon, University of Zurich, Vista Klinik, Queen's University, Belfast, Fundacion Clinic per a la Recerca Biomédica
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 8 Apr 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.
The goal of this prospective, multinational, multicenter observational study is to assess and predict progression in non-foveal, non-vision compromising atrophic AMD on an individual-based level over two years. The main objectives of this study are:
- Assess the individual progression rate of a patient in non-foveal, non-vision compromising atrophic AMD and assess personalized risk of progression based on imaging.
- Identify and quantify focal and global alterations in the retina in regard to disease progression.
- Evaluate the monitoring of AMD progression using approved AI algorithms.
All patients will be followed for 24 months with 6 month intervals to assess clinical changes. Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures:
- Scanning Laser Fundus Photography
- Color Fundus Photography (CFP)
- Optical Coherence Tomography (OCT)
- Optical Coherence Tomography Angiography (OCTA)
Patients will be asked for their medical history. Standard ophthalmic examination, as well as a questionnaire on visual function will be carried out.
No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from each center's respective outpatient clinic and/or by referral from primary eye care (e.g. optometrist).
Key inclusion criteria (4 listed)
- Age: 55-99 years old
- Complete RPE and outer retinal atrophy (cRORA). This is (1) a region of hypertransmission of at least 250 µm in diameter, (2) a zone of attenuation or disruption of the RPE of at least 250 µm in diameter, (3) evidence of overlying photoreceptor degeneration, and (4) absence of scrolled RPE or other signs of an RPE tear.
- If both eyes are eligible, both eyes will be included in the cohort study.
- Clear optical media and adequate pupillary dilation for imaging and functional testin
Key exclusion criteria (10 listed)
- Any surgical treatment of the eye within 3 months prior to baseline in the study eye
- History of anti-VEGF treatment in the study eye before baseline
- History of pseudophakic cystoid macular edema (Irvine Gass Syndrome) in the study eye
- History of uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg despite treatment with IOP lowering medication), or C/D Ratio > 0.9
- Any concurrent intraocular condition in the study eye (e.g. advanced cataract or moderate/severe diabetic retinopathy) that, in the opinion of the investigator, will most likely require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition
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
To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for fast geographic atrophy (GA) progression
Time frame: 2 years
The association between biomarkers and GA progression will be assessed by linear mixed models. Artificial intelligence models will be applied to assess progression speed and predict local and global progression. Mixed Effects models will be calculated to estimate the association between the above mentioned independent variables, including the timepoint as an independent variable, on individual markers of progression (RPE and PR thinning). The r-squared value of the predicted increase in atrophy area will be used as an endpoint assessment to evaluate the predictive model.
2 secondary outcomes
To identify and quantify disease progression-related biomarkers
Time frame: 2 years
To evaluate monitoring AMD progression using approved AI algorithms.
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 15 May 2025.
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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.
7 sites in 6 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 and Geographic Atrophy, run by Medical University of Vienna at 7 sites in 6 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Switzerland, Austria, France, Slovenia, Spain and 1 more country. 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?
Contact Gregor Reiter, Priv.-Doz. Ing. DDr., BA MSc (+43 1 40400-73419, gregor.reiter@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for fast geographic atrophy (GA) progression (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2025.