NCT05093374 Treatment of Neovascular AMD: Artificial Intelligence in Real-world Setting
| NCT ID | NCT05093374 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Medical University of Vienna |
| Condition | Exudative Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 290 participants |
| Start Date | 2021-03-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 290 participants in total. It began in 2021-03-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Stefan Sacu, MD
PRINCIPAL INVESTIGATOR
Medical University of Vienna, Dept. of Ophthalmology and Optometry
Frequently Asked Questions
Who can join the NCT05093374 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 100 Years, studying Exudative Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05093374 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05093374 currently recruiting?
Yes, NCT05093374 is actively recruiting participants. Contact the research team at stefan.sacu@meduniwien.ac.at for enrollment information.
Where is the NCT05093374 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT05093374 clinical trial?
NCT05093374 is sponsored by Medical University of Vienna. The principal investigator is Stefan Sacu, MD at Medical University of Vienna, Dept. of Ophthalmology and Optometry. The trial plans to enroll 290 participants.