Personalized Treatment Aided by Automated Analysis of Fluid in Active Neovascular Age-related Macular Degeneration (nAMD) in a Prospective, Multicenter, Randomized Study.
Trial ID: NCT05093374
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: PHASE4
Start date: 2021-03-01
Completion date: 2025-12-31
Sponsor: Medical University of Vienna
Conditions: Exudative Macular Degeneration
Interventions: anti-VEGF agent; anti-VEGF agent
Locations: Department of Ophthalmology, Medical University of Vienna, Austria
Countries: Austria
Enrollment: 290
Age range: 50 Years - 100 Years
Sex: 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).

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

Outcomes:
Number of injections