Treatment of neovascular AMD: Artificial intelligence in real-world setting

Phase 4

Not yet recruiting

Conditions: neovasclar AMD

Registration Number: 2024-518482-99-01

Lead Sponsor: Medical University Of Vienna

Brief Summary: 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 290

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)
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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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).;Secondary Objective: Not applicable;Primary end point(s): Non-inferiority of Cohort 1 (treatment decision based on quantitative criteria) in comparison to Cohort 2 (treatment decision based on qualitative criteria), measured in gain of BCVA;Timepoint(s) of evaluation of this end point: The primary end point is measured after 12 months of follow-up.
- Number of anti-VEGF injections		- Number of anti-VEGF injections

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Non-inferiority of Cohort 1 (treatment decision based on quantitative criteria) in comparison to Cohort 2 (treatment decision based on qualitative criteria), measured in reduction of central retinal thickness (µm);Timepoint(s) of evaluation of this end point: The secondary end point is measured after 12 months of follow-up.
- Best-corrected visual acuity (BCVA) assessed by ETDRS Score		- Best-corrected visual acuity (BCVA) assessed by ETDRS Score
- Anatomic changes in the macula assessed with OCT (central retinal thickness, fluid volumes in nl, additional morphologic changes)		- Anatomic changes in the macula assessed with OCT (central retinal thickness, fluid volumes in nl, additional morphologic changes)
- Formation of geographic-like macular atrophy assessed by fundus photography with special filters		- Formation of geographic-like macular atrophy assessed by fundus photography with special filters
- Formation of retinal tears assessed by OCT		- Formation of retinal tears assessed by OCT
- Chorioretinal perfusion changes (OCTA)		- Chorioretinal perfusion changes (OCTA)
- Perfusion of the neovascular lesion (OCTA, FA)		- Perfusion of the neovascular lesion (OCTA, FA)
- Changes in macular sensitivity (MP)		- Changes in macular sensitivity (MP)
- Assessment of fibrosis formation and deterioration of the retinal pigment epithelium (PS-OCT)		- Assessment of fibrosis formation and deterioration of the retinal pigment epithelium (PS-OCT)
- Quality-of-life assessed by questionnaire		- Quality-of-life assessed by questionnaire

Trial Locations

Locations (2): Medical University Of Vienna
🇦🇹
Vienna, Austria
Landesklinikum Horn
🇦🇹
St. Pölten, Austria
Medical University Of Vienna
🇦🇹Vienna, Austria
Stefan Sacu
Site contact
+4314040079375
stefan.sacu@meduniwien.ac.at