Treatment of Neovascular AMD: Artificial Intelligence in Real-world Setting
Exudative Macular Degeneration
About this trial
This is an interventional treatment trial for Exudative Macular Degeneration
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 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
Sites / Locations
- Department of Ophthalmology, Medical University of Vienna, AustriaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cohort 1 - Quantitative
Cohort 2 - Qualitative
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.
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.