Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression

Age-Related Macular Degeneration Clinical Trial

— APENNINES  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06351657
• Other study ID #: 1088/2024
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: July 2027

Study information

• Verified date: April 2024
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Disease Progression
• Geographic Atrophy
• Macular Degeneration

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Medical University of Vienna	Centre Hospitalier Universitaire Dijon, Fundacion Clinic per a la Recerca Biomédica, Queen's University, Belfast, University Medical Centre Ljubljana, University of Zurich, Vista Klinik

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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.	2 years
Secondary	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	2 years