Personalized Treatment Aided by Automated Analysis of Fluid in Active Neovascular Age-related Macular Degeneration (nAMD) in a Prospective, Multicenter, Randomized Study.
Overview
- Phase
- Phase 4
- Intervention
- anti-VEGF agent
- Conditions
- Exudative Macular Degeneration
- Sponsor
- Medical University of Vienna
- Enrollment
- 290
- Locations
- 1
- Primary Endpoint
- Number of injections
- Status
- Recruiting
- Last Updated
- last year
Overview
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).
Investigators
Stefan Sacu
Head of Vienna Clinical Trial Center, Dept. of Ophthalmology and Optometry
Medical University of Vienna
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort 1 - Quantitative
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.
Intervention: anti-VEGF agent
Cohort 2 - Qualitative
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.
Intervention: anti-VEGF agent
Outcomes
Primary Outcomes
Number of injections
Time Frame: 12 months
Number of injections necessary within study period
Secondary Outcomes
- Number of injections Best-corrected visual acuity (BCVA) assessed by ETDRS Score(12 months)
- Macular fluid volumes(12 months)
- Formation of geographic-like macular atrophy(12 months)
- Chorioretinal perfusion(12 months)
- Perfusion of the neovascular lesion(12 months)
- Central retinal thickness(12 months)
- Quality of Life by Questionnaire(12 months)
- Formation of retinal tears(12 months)