Personalized treatment aided by automated analysis of fluid in active neovascular age-related macular degeneration (nAMD) in a prospective, multicenter, randomized study

Medical University Of Vienna2 sites in 1 country290 target enrollmentJanuary 15, 2025

DrugsEylea 40 mg/mL solution for injection in a vial BAY86-5321 BAY 86-5321 ABP 938 Beovu 120 mg/ml solution for injection in pre-filled syringe BAY 86-5319 AVE0005 VEGF TRAP Lucentis 10 mg/ml solution for injection in pre-filled syringe

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Not specified
Sponsor: Medical University Of Vienna
Enrollment: 290
Locations: 2
Primary Endpoint: - Number of anti-VEGF injections
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

euclinicaltrials.eu

Start Date

January 15, 2025

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Medical University Of Vienna

Responsible Party

Principal Investigator

Department of Ophthalmology and Optometry

Scientific

Medical University Of Vienna

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)
•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.)

Outcomes

Primary Outcomes

- Number of anti-VEGF injections

Secondary Outcomes

- 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)
- Formation of geographic-like macular atrophy assessed by fundus photography with special filters
- Formation of retinal tears assessed by OCT
- Chorioretinal perfusion changes (OCTA)
- Perfusion of the neovascular lesion (OCTA, FA)
- Changes in macular sensitivity (MP)
- Assessment of fibrosis formation and deterioration of the retinal pigment epithelium (PS-OCT)
- Quality-of-life assessed by questionnaire