Treatment of Neovascular AMD: Artificial Intelligence in Real-world Setting
Recruiting
Phase 4Interventional Study
Exudative Macular Degeneration
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 100
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
290 (estimated)
Sponsor
Medical University of Vienna · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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Eligibility Criteria
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…
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
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