Using computer analysis of eye fluid to guide injection treatment for wet macular degeneration
Tests AI fluid analysis to guide anti-VEGF injections in adults with wet macular degeneration.
Plain-language title generated from the registry record
Registry title: Treatment of Neovascular AMD: Artificial Intelligence in Real-world Setting
Key facts
- Where
- Vienna, AustriaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 100 years old?
Source: NCT05093374, who can take part
Where in Austria
- Department of Ophthalmology, Medical University of Vienna, AustriaVienna, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University of Vienna
- Trial code
- NCT05093374
- Record updated
- 25 November 2024
- Original description
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).Read full original descriptionShow less
Personalized Treatment Aided by Automated Analysis of Fluid in Active Neovascular Age-related Macular Degeneration (nAMD) in a Prospective, Multicenter, Randomized Study.
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).
Inclusion: Adults ≥ 50 years; Active neovascular AMD (classic, occult choroidal neovascularization (CNV), RAP lesion or PCV lesion) assessed by OCT, OCTA, FA; Patients who have a BCVA score better or equal 0.1 (20/200) in the study eye using ETDRS; No significant fibrosis or geographic atrophy (GA) involving the fovea; Willingness and ability to comply with study visits and study procedures; Signed informed consent form.
Exclusion: Any surgical treatment of the eye within 3 months prior to baseline 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 diabetic retinopathy) that, in the opinion of the investigator, will most likely require medical or surgical intervention during the twelve-month 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) during the study period; History of pseudophakic cystoid macular edema (Irvine Gass Syndrome); History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Visit 0, or a history of post-operative complications within the last 12 months preceding Visit 0 in the study eye (uveitis, cyclitis etc.); Active or suspected ocular or periocular infection in the study eye; Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye; Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment; Hypersensitivity to Fluoresceine, Ranibizumab, Aflibercept, Brolucizumab or to any of the excipients (Polysorbate 20, Sodium dihydrogen phosphate, monohydrate, Disodium hydrogen phosphate, heptahydrate, Sodium chloride, Sucrose); Aphakia in the study eye; Presence of a retinal pigment epithelial tear involving the macula in the study eye; Active intraocular inflammation (grade trace or above) in the study eye; Evidence of current infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye; Presence of corneal decompensation, haze or scaring with an impact on BCVA.