Treatment of Neovascular AMD: Artificial Intelligence in Real-world Setting
- Conditions
- Exudative Macular Degeneration
- Interventions
- Drug: anti-VEGF agent
- Registration Number
- NCT05093374
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
The purpose of this study is to implement quantitative assessment tools for the treatment of active neovascular AMD patients in a real-world setting in order to provide advantages for both patients (treatment burden) and healthcare system (scheduling visits/treatments).
- Detailed Description
Neovascular age-related macular degeneration (nAMD) is a significant burden to health care systems in industrialized countries. Due to its chronic nature, continuous follow-up and treatment is needed to prevent significant loss of visual function in patients with nAMD.
Vascular endothelial growth factor (VEGF) plays a major role in the pathomechanisms of nAMD and large multicenter trials have shown that intravitreal application of substances which intercept the VEGF pathway can interrupt the progression of nAMD and improve the visual outcome.
As every single injection bears the risk of sight-threatening complications and increases the financial burden to health care providers, several studies have tested different treatment regimens, to decrease the number of applicated injections without compromising the gains in visual acuity. Thereby, strict protocols have been compared to flexible "as needed" regimens (pro re nata, PRN) and regimens with proactive increments of injection intervals (treat and extend, T\&E).
Studies have indicated that the outcome of anti-VEGF treatment is better in standardized clinical trials than in so-called "real world settings". This is explained by tight exclusion criteria of sponsored trials, the shorter follow-up time and the small number of patients that are treated per center, resulting in a better standard of care.
PRN as well as T\&E management showed disadvantages such as significant less vision gain in PRN and possible over treatment in T\&E.
Recently, additional treatment criteria were described to improve the patients care.
Advances in diagnostic precision by SD-OCT using automated algorithms to accurately measure fluid volumes in all compartments are solid tools to determine disease activity. They allow to precisely quantifying the impact of therapeutic parameters on disease activity.
Multicenter study analyses have shown that the amount of intraretinal fluid has a significant effect on vision outcome. Subretinal fluid or Pigmentepithelial detachment have been described to be less important. These findings were the basis for designing an efficient point-of-care management. Automated quantification of the fluid amount using artificial intelligence (AI) may serve as a reliable and objective method to determine the personalized point-of-care.
To prove the efficacy of point-of-care management, prospective studies in real-world settings are required. More data is required to assess the outcome of real-world settings and find ways to improve treatment results, when larger amounts of patients are treated and less resources are available for decision making.
The purpose of this study is to implement quantitative assessment tools for the treatment of neovascular AMD patients in a real-world setting in order to provide advantages for both patients (treatment burden) and healthcare system (scheduling visits/treatments).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 290
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 - Quantitative anti-VEGF agent Patients will undergo monthly follow-up visits including fluid quantification and will be retreated in case of active disease, which is defined as: * reduction of 5 EDTRS letters or more related to any (suspected) neovascular activity compared to previous visit * new sub-retinal hemorrhage * increase \>50% in IRF volume in the central 1 mm compared to month 2 * increase \> 50 % in SRF volume in the central 1 mm compared to month 2 * in case of NO intra- and/or subretinal fluid (=less than 10nl) in visits 2 or 3, retreat if fluid in central 1mm ≥ 10nl Presence/change of sub- and intraretinal fluid will be assessed objectively by AI software and the results will be provided during the visit to the investigator. The final decision for/against retreatment is always made by the discretion of the clinical investigator. Cohort 2 - Qualitative anti-VEGF agent Patients will undergo monthly follow-up visits. Treatment will be performed in case of active disease, which is defined as: * reduction of 5 EDTRS letters or more related to any (suspected) neovascular activity * new sub-retinal hemorrhage * any fluid In this cohort the amount of retinal fluid will not be assessed by AI software at the time of retreatment.
- Primary Outcome Measures
Name Time Method Number of injections 12 months Number of injections necessary within study period
- Secondary Outcome Measures
Name Time Method Number of injections Best-corrected visual acuity (BCVA) assessed by ETDRS Score 12 months Longitudinal changes within each group in ETDRS-BCVA and quantitative anatomic measurements in the macula assessed with noninvasive imaging
Macular fluid volumes 12 months Changes in total amount of fluid in nanoliters within the central millimeter assessed with automated quantitative fluid measurement on noninvasive OCT imaging.
Formation of geographic-like macular atrophy 12 months Formation of geographic-like macular atrophy assessed by fundus photography with specials filters
Chorioretinal perfusion 12 months Chorioretinal perfusion (OCTA, ICG)
Perfusion of the neovascular lesion 12 months Perfusion of the neovascular lesion (OCTA, FA and ICG, SS)
Central retinal thickness 12 months Measurement of central retinal thickness in micrometers on noninvasive OCT imaging
Quality of Life by Questionnaire 12 months Quality of Life assessed by Questionnaire NEI - VFQ 25
Formation of retinal tears 12 months Formation of retinal tears assessed by OCT
Trial Locations
- Locations (1)
Department of Ophthalmology, Medical University of Vienna, Austria
🇦🇹Vienna, Austria