Nevoascular age related macular degneration (nAMD)
Conditions
Interventions
Trade Name: Lucentis
Product Name: Lucentis
Product Code: EMEA/H/C/000715
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Concentration unit: mg/ml
Sponsors
Medical University of Vienna, Department of Ophthalmology and Optometry
Eligibility
Sex/Gender
All
Inclusion 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 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: - Hypersensitivity to Fluoresceine, Ranibizumab, Aflibercept, Bevacizumab, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).;Secondary Objective: Not applicable;Primary end point(s): Non-inferiority of Cohort 1 (treatment decision based on quantitative criteria) in comparison to Cohort 2 (treatment decision based on qualitative criteria), measured in gain of BCVA;Timepoint(s) of evaluation of this end point: The primary end point is measured after 12 months of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Non-inferiority of Cohort 1 (treatment decision based on quantitative criteria) in comparison to Cohort 2 (treatment decision based on qualitative criteria), measured in reduction of central retinal thickness (µm);Timepoint(s) of evaluation of this end point: The secondary end point is measured after 12 months of follow-up. | — |
Countries
Austria
Contacts
Public ContactVienna Clinical Trial Center
MUW Dept of Ophthalmology and Optometry
Outcome results
None listed