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Treatment of neovascular AMD: Artificial intelligence in real-world setting
EU CTIS ID: 2024-518482-99-01
What this study is testing
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).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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
You likely can't join if
- - 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)
- - 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
See the full eligibility 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
- - 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)
- - 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
- - 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.