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New treatment option for Exudative Macular Degeneration
Official title Treatment of Neovascular AMD: Artificial Intelligence in Real-world Setting
ClinicalTrials.gov ID: NCT05093374
What this study is testing
What is anti-VEGF agent?
anti-VEGF agent is an investigational medicine, given as a monthly injectable medicine, being studied as a potential treatment for exudative macular degeneration.
Also referred to as Cohort 1 - Quantitative.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 100
You may be able to join if
- 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
You likely can't join if
- Hypersensitivity to Fluoresceine, Ranibizumab, Aflibercept, Brolucizumab or to any of the excipients (Polysorbate 20, Sodium dihydrogen phosphate...
- 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...
- History of uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg despite treatment with IOP lowering medication)...
- Aphakia in the study eye
See the full eligibility 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
- Hypersensitivity to Fluoresceine, Ranibizumab, Aflibercept, Brolucizumab or to any of the excipients (Polysorbate 20, Sodium dihydrogen phosphate, monohydrate, Disodium hydrogen phosphate, heptahydrate, Sodium chloride...
- 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...
- 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...
- 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 how well it works, compliance or require intraocular surgery (except for...
- Presence of corneal decompensation, haze or scaring with an impact on BCVA
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, State of Vienna, Austria
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, State of Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.