RECRUITINGPhase 4INTERVENTIONAL

Treatment of Neovascular AMD: Artificial Intelligence in Real-world Setting

Personalized Treatment Aided by Automated Analysis of Fluid in Active Neovascular Age-related Macular Degeneration (nAMD) in a Prospective, Multicenter, Randomized Study.

About This Trial

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).

Who May Be Eligible (Plain English)

Inclusion Criteria - 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 willing to sign a consent form form Exclusion Criteria - 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) - Any surgical treatment of the eye within 3 months prior to baseline in the study eye - 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.) - 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 - Aphakia in the study eye - Presence of a retinal pigment epithelial tear involving the macula in the study eye - 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 - Active intraocular inflammation (grade trace or above) in the study eye - Active or suspected ocular or periocular infection in the study eye ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria * 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 Criteria * 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) * Any surgical treatment of the eye within 3 months prior to baseline in the study eye * 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.) * 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 * Aphakia in the study eye * Presence of a retinal pigment epithelial tear involving the macula in the study eye * 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 * Active intraocular inflammation (grade trace or above) in the study eye * 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 * Evidence of current infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye * 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 * Presence of corneal decompensation, haze or scaring with an impact on BCVA

Treatments Being Tested

DRUG

anti-VEGF agent

All patients will be treated at baseline. A loading dose of 2 additionally monthly treatments will be performed at months 1 and 2. Patients showing no intra- and/or subretinal fluid in the central 1mm subfield at month 1, no treatment will be given till any disease activity is documented. 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. Should the Investigators decision differ from the study protocol, the reason will be indicated in the CRF.

DRUG

anti-VEGF agent

Locations (1)

Department of Ophthalmology, Medical University of Vienna, Austria

Vienna, Vienna, Austria