RetInSight Fluid Monitor provides next evolutionary step in monitoring of neovascular age-related macular degeneration

RetInSight has obtained a CE mark under the MDR 2017/745 for the RetInSight Fluid Monitor: an AI-based software solution to be used by eye care specialists and trained staff as a clinical decision support system for the monitoring of patients with neovascular age-related macular degeneration (nAMD). It is first in class and ready for use in clinical practice with Optical Coherence Tomography (OCT) scans generated by the Heidelberg Spectralis OCT platform, offering the eye care specialist a comprehensive result while the patient is on site.

The RetInSight Fluid Monitor is CE marked, complying with all applicable safety and performance requirements of Regulation (EU) 2017/745 MDR for medical devices in Europe*. The innovative solution supports eye care specialists in the optimization and personalization of therapy, with the aim of improving patient outcomes and increasing clinical efficiency.

RetInSight Fluid Monitor: the next evolutionary step in nAMD monitoring

RetInSight introduces a shift from the surrogate biomarker, central retinal thickness, and the observer interpretation of retinal fluid volumes in OCT images, to the precise measurement of retinal fluid by an AI-based reliable, accurate “fluid activity meter”. The RetInSight Fluid Monitor helps eye care specialists to elevate the standard of care by precisely identifying, localising and quantifying retinal fluid volumes in routine OCT-images in a fast, objective and quantitative manner and thereby closing the gap between real-world treatment outcomes and clinical trial results.[1]^{, [2], [3]}

Prof. Ursula Schmidt-Erfurth, leading retina-specialist and ophthalmic AI pioneer, explains: “nAMD is a devastating progressive eye disease that affects about 25% of EU citizens older than 60 years, a number expected to rise significantly in the coming years.[4] If left untreated, this will lead to substantial irreparable loss of central vision in the population. As it affects the central acuity that is needed for essential functions of daily life such as reading, driving and recognizing faces, in other words: an autonomous and joyful lifestyle.”

“Years of research by retinal experts have demonstrated that, when it comes to the severe (neovascular) stage of AMD, fluid volumes are a better biomarker for disease activity and therapeutic efficacy than central subfield thickness. Yet, it is not feasible to evaluate the amount of pathological fluid with the human eye, even by expert-graders. That is where the RetInSight “fluid activity meter” comes into play.”

The RetInSight Fluid Monitor assigns a label to each OCT-pixel denoting its fluid type as intraretinal fluid (IRF) and subretinal fluid (SRF), and its exact location within the central 1-mm and 6-mm macular area. The AI-based software converts the pixel numbers into measurements in nanoliters and provides a comprehensive result by a mouse click during the patient’s visit at the doctor’s office.

Many studies have shown that the current standard of monitoring in nAMD is less reliable, subjective and qualitative. At best, only a modest correlation between visual acuity and central subfield thickness can be established. Manual fluid assessment, as done in clinical trials, is an extremely time-consuming task that can be compromised due to subjectivity and fatigue and cannot easily be delegated or monitored over time. Researchers and clinicians therefore suggest AI-based analyses as the next logical, evolutionary step in nAMD monitoring.

Optimized and personalized care: reducing the risk of over- and under-treatment

Throughout Europe, nAMD represents a heavy disease burden that continues to increase, leading to severe vision loss and significant healthcare costs.[5] VEGF inhibitors used for the treatment of nAMD are costly[6] and the experienced visual gains by patients in real life are substantially lower than the superior outcomes observed in clinical trials.[7] This dilemma is mainly caused by delayed or omitted therapeutic interventions; like eye injections. The key to treatment success is to take the right treatment decisions throughout the patient’s lifetime.[8]

The precision measurements obtained with the RetInSight Fluid Monitor provide eye care specialists with a solid basis for confident anti-VEGF decisions and long-term monitoring, supporting the optimization and personalization of treatment regimens in a user-friendly manner. Ultimately, this should result in a lower risk of disease progression and irreversible vision loss caused by under-treatment, and less ineffective use of healthcare resources for one of the costliest eye diseases due to inadequate treatment. [9]^{, [10], [11]}

Corinna zur Bonsen-Thomas, Managing Partner, CEO & Founder of RetInSight, adds the perspective of healthcare providers: “Precision measurements foster personalized medicine in nAMD. Over time, they can serve as a tool to obtain improved insight into the health care spending and offer practical handles to improve budget efficacy. If we add the advantage of a more efficient workflow, potentially resulting in better patient flow and access to eye care, it becomes clear that everybody wins with the Fluid Monitor.”

It is also expected that the easily understandable personal Fluid Monitor report, with evidence of fluid progression and treatment response, will increase trust and compliance amongst patients.

About RetInSight

The RetInSight Fluid Monitor is the first transformational AI-solution originating from the pipeline of RetInSight, founded in April 2020 as a spin-off from the Department of Ophthalmology & Optometry of the Medical University of Vienna, Austria. The company embarked on a challenging, but clear mission: helping achieve that living longer, which comes with a significant rise in the prevalence of age-related eye disease and vision loss, does not mean seeing less or not living in full.

* All software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is now classified as class IIa (medium risk). This means that the manufacturer must receive a declaration of conformity from a notified body following its conformity assessment. There are more detailed requirements for post-market surveillance and post-market clinical follow-up; taking a life-cycle approach to safety, backed up by clinical data.

[1] Pawloff et al. “A systematic correlation of central subfield thickness (CSFT) with retinal fluid volumes quantified by deep learning in the major exudative macular diseases.” Retina (Philadelphia, Pa.), 10.1097/IAE.0000000000003385. 17 Dec. 2021

[2] Schmidt-Erfurth et al. “AI-based monitoring of retinal fluid in disease activity and under therapy.” Progress in retinal and eye research vol. 86 (2022): 100972.

[3] Wykoff CC, Clark WL, Nielsen JS, Brill JV, Greene LS, Heggen CL. Optimizing Anti-VEGF Treatment Outcomes for Patients with Neovascular Age-Related Macular Degeneration. J Manag Care Spec Pharm. 2018 Feb;24(2-a Suppl):S3-S15. doi: 10.18553/jmcp.2018.24.2-a.s3. PMID: 29383980.

[4] EURETINA Retinal Diseases in Europe; Prevalence, incidence and healthcare needs; Aug 2017

[5] EURETINA Retinal Diseases in Europe; Prevalence, incidence and healthcare needs; Aug 2017

[6] Cruess, Alan F et al. “Economic burden of bilateral neovascular age-related macular degeneration: multi-country observational study.” PharmacoEconomics vol. 26,1 (2008): 57-73.

[7] Wykoff CC, Clark WL, Nielsen JS, Brill JV, Greene LS, Heggen CL. Optimizing Anti-VEGF Treatment Outcomes for Patients with Neovascular Age-Related Macular Degeneration. J Manag Care Spec Pharm. 2018 Feb;24(2-a Suppl):S3-S15. doi: 10.18553/jmcp.2018.24.2-a.s3. PMID: 29383980.

[8] Boulanger-Scemama E, et al. Ranibizumab for exudative age-related macular degeneration: A five year study of adherence to follow-up in a real-life setting. J Fr Ophtalmol. 2015 Sep;38(7):620-7.

[9] Cruess, Alan F et al. “Economic burden of bilateral neovascular age-related macular degeneration: multi-country observational study.” PharmacoEconomics vol. 26,1 (2008): 57-73.

[10] Brown, Melissa M et al. SOCIETAL COSTS ASSOCIATED WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION IN THE UNITED STATES, Retina: February 2016 - Volume 36 -Issue 2 - p 285-298

[11] Curtis, Lesley H et al. “Treatment patterns for neovascular age-related macular degeneration: analysis of 284 380 medicare beneficiaries.” American journal of ophthalmology vol. 153,6 (2012): 1116-24.e1.