Using artificial intelligence to treat neovascular age-related macular degeneration
Official title: Personalized Treatment Aided by Automated Analysis of Fluid in Active Neovascular Age-related Macular Degeneration (nAMD) in a Prospective, Multicenter, Randomized Study.
Run by Medical University of Vienna · NCT05093374 · Data updated 2026-11-12
This study is testing if using artificial intelligence can help doctors find better ways to treat people with neovascular age-related macular degeneration while making the treatment process easier for patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years to 100 Years |
| Sex | All |
| Enrollment | 290 (estimated) |
| Sponsor | Medical University of Vienna Academic / other |
| Drugs / interventions | Ranibizumab, Brolucizumab |
| Locations | 1 site (Vienna, State of Vienna) |
| Status | Recruiting |
| Started | March 1, 2021 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | November 25, 2024 |
| Trial ID | NCT05093374 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 50 and older with active neovascular AMD and a baseline visual acuity score of 20/200 or better.
✕Probably not a fit
Patients with significant eye conditions such as fibrosis or geographic atrophy involving the fovea may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to implement quantitative assessment tools for treating patients with active neovascular age-related macular degeneration (nAMD) in a real-world setting. It focuses on optimizing treatment regimens to reduce the treatment burden on patients and healthcare systems while maintaining visual outcomes. The study will evaluate the effectiveness of anti-VEGF agents and compare different management strategies, including strict protocols and flexible regimens. By addressing the challenges faced in real-world settings, the study seeks to improve patient care and outcomes.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and less burdensome treatment options for patients with neovascular AMD.
How similar studies have gone: Previous studies have shown that standardized clinical trials yield better outcomes than real-world settings, indicating the need for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Department of Ophthalmology, Medical University of Vienna, Austria
Vienna, State of Vienna, Austria Recruiting
Study contacts
- Principal investigator: Stefan Sacu, MD — Medical University of Vienna, Dept. of Ophthalmology and Optometry
- Study coordinator: Stefan Sacu, MD
- Email: stefan.sacu@meduniwien.ac.at
- Phone: +43 1 40400
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Low-dose oral doxycycline targeting MMP-9 for persistent wet AMD
This trial tests whether taking low-dose doxycycline daily can help people with wet AMD who still have sub-retinal fluid despite regular anti-VEGF eye injections.
-
Steatotic Liver Disease in Austria: A Long-Term Registry and Biobank
This registry will follow adults with suspected or confirmed steatotic liver disease in Austria to learn about how the disease progresses and which non-invasive tests best predict outcomes.
-
Kidney fibrosis imaging with Ga-68 FAPI PET/CT in CKD
This study tests whether a Ga-68 FAPI PET/CT scan can reflect how much fibrosis is in the kidneys of people with chronic kidney disease.
-
Myo-Inositol for Glycemic Control in Gestational Diabetes
This study tests whether taking myo-inositol with folic acid can improve blood sugar control and reduce inflammation in pregnant people with gestational diabetes.
-
BAL balance: ARDS through lung lavage and imaging to find different ARDS types
This study tests how bronchoalveolar lavage fluid and chest CT imaging can reveal different ARDS subtypes in adults with ARDS or severe pneumonia in the ICU.
-
Does a CDT level at ICU admission predict short-term outcomes in critically ill adults?
This study tests whether high carbohydrate-deficient transferrin levels at ICU admission can predict worse short-term outcomes for adults with critical illness from emergency department admissions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.