Aflibercept for Neovascular age-related macular degeneration

Inclusion criteria

• {"criterion_text":"- Adults ≥ 50 years\n- Active neovascular AMD (classic, occult choroidal neovascularization (CNV), RAP lesion or PCV lesion) assessed by OCT, OCTA, FA\n- Patients who have a BCVA score better or equal 0.1 (20/200) in the study eye using ETDRS\n- No significant fibrosis or geographic atrophy (GA) involving the fovea\n- Willingness and ability to comply with study visits and study procedures\n- Signed informed consent form"}

Exclusion criteria

• {"criterion_text":"- 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)\n- Active or suspected ocular or periocular infection in the study eye\n- Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye\n- Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment\n- Evidence of current infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye\n- 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\n- Presence of corneal decompensation, haze or scaring with an impact on BCVA\n- Any surgical treatment of the eye within 3 months prior to baseline in the study eye\n- History of pseudophakic cystoid macular edema (Irvine Gass Syndrome)\n- 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.)\n- 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\n- Aphakia in the study eye\n- Presence of a retinal pigment epithelial tear involving the macula in the study eye\n- 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\n- Active intraocular inflammation (grade trace or above) in the study eye"}

Primary endpoints

• {"endpoint_text":"- Number of anti-VEGF injections","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Best-corrected visual acuity (BCVA) assessed by ETDRS Score","definition_or_measurement_approach":"Measured using ETDRS Score"}
• {"endpoint_text":"- Anatomic changes in the macula assessed with OCT (central retinal thickness, fluid volumes in nl, additional morphologic changes)","definition_or_measurement_approach":"Assessed by OCT including central retinal thickness and fluid volumes (nl) and morphological changes"}
• {"endpoint_text":"- Formation of geographic-like macular atrophy assessed by fundus photography with special filters","definition_or_measurement_approach":"Assessed by fundus photography with special filters"}
• {"endpoint_text":"- Formation of retinal tears assessed by OCT","definition_or_measurement_approach":"Assessed by OCT"}
• {"endpoint_text":"- Chorioretinal perfusion changes (OCTA)","definition_or_measurement_approach":"Assessed by OCTA"}
• {"endpoint_text":"- Perfusion of the neovascular lesion (OCTA, FA)","definition_or_measurement_approach":"Assessed by OCTA and fluorescein angiography (FA)"}
• {"endpoint_text":"- Changes in macular sensitivity (MP)","definition_or_measurement_approach":"Assessed by microperimetry (MP)"}
• {"endpoint_text":"- Assessment of fibrosis formation and deterioration of the retinal pigment epithelium (PS-OCT)","definition_or_measurement_approach":"Assessed by PS-OCT"}
• {"endpoint_text":"- Quality-of-life assessed by questionnaire","definition_or_measurement_approach":"Assessed using patient questionnaires (quality-of-life instruments)"}

Austria

Earliest CTIS Part Ii Submission Date

19-11-2024

Latest Decision Or Authorization Date

15-01-2025

Processing Time Days

57

Number Of Sites

2

Number Of Participants

290

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria