Using artificial intelligence to treat neovascular age-related macular degeneration
Personalized Treatment Aided by Automated Analysis of Fluid in Active Neovascular Age-related Macular Degeneration (nAMD) in a Prospective, Multicenter, Randomized Study.
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 |
| Enrollment | 290 (estimated) |
| Ages | 50 Years to 100 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Drugs / interventions | Ranibizumab, Brolucizumab |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT05093374 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with significant eye conditions such as fibrosis or geographic atrophy involving the fovea may not benefit from this study.
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 performed: Previous studies have shown that standardized clinical trials yield better outcomes than real-world settings, indicating the need for this novel approach.
Eligibility criteria
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 this trial is running
Vienna, State of Vienna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.