NCT05093374RecruitingPhase 4
Treatment of Neovascular AMD: Artificial Intelligence in Real-world Setting
Personalized Treatment Aided by Automated Analysis of Fluid in Active Neovascular Age-related Macular Degeneration (nAMD) in a Prospective, Multicenter, Randomized Study.
Source: ClinicalTrials.gov · Last updated 25 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 290 (estimated)
- First submitted
- 12 Jun 2020
- Start date
- 1 Mar 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Medical University of Vienna
- Diseases
- Macular degeneration
- NCT number
- NCT05093374
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 290
- From 1 Mar 2021 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any surgical treatment of the eye within 3 months prior to baseline in the study eye
- 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
- 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
- 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
Other illness
- 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.)
- 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
Lab values
- 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)
Other
- Aphakia in the study eye
- Presence of a retinal pigment epithelial tear involving the macula in the study eye
- Active intraocular inflammation (grade trace or above) in the study eye
- Evidence of current infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
- Presence of corneal decompensation, haze or scaring with an impact on BCVA
Who the study is looking for
- 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
Age in the registry: 50 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Ophthalmology, Medical University of Vienna, Austria Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.