Overview

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

Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical University of Vienna
Treatments:
Bevacizumab
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