Exsudative Maculopathies MedDRA version: 17.0 Level: PT Classification code 10063381 Term: Polypoidal choroidal vasculopathy System Organ Class: 10015919 - Eye disorders MedDRA version: 17.0 Level: PT Classification code 10052501 Term: Detachment of retinal pigment epithelium System Organ Class: 10015919 - Eye disorders MedDRA version: 17.0 Level: LLT Classification code 10069125 Term: Retinal angiomatous proliferation System Organ Class: 10015919 - Eye disorders MedDRA version: 17.0 Level:
Conditions
Interventions
Trade Name: Eylea 40 mg/ml intravitreal injection
Product Name: Aflibercept
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Aflibercept
CAS Number: 862111-32-8
C
Sponsors
Universitätsklinik für Augenheilkunde und Optometrie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Treatment naïve eyes with following subtypes of exsudative maculopathies will be included: • Retinal angiomatous proliferation lesions (RAP) • Pigment epithelium detachment (PED) • Hemorrhagic CNV (if the size of hemorrhage is either >50% of the lesion area or >1 disk area in size) ) • Polypoidal choroidal vasculopathy (PCV) Patients who have a BCVA score better than 20/400 in the study eye using ETDRS Willingness and able to comply with clinic visits and study-related procedures Proved a 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Any prior treatment for exsudative maculopathy including photodynamic therapy and intravitreal anti-VEGF application in the study eye Any surgical treatment of the eye within 3 months prior to baseline in the study eye History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Visit 1, or a history of post-operative complications within the last 12 months preceding Visit 1 in the study eye (uveitis, cyclitis etc.) History of uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite treatment with anti-glaucoma mediation) Aphakia or absence of the posterior capsule 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., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either 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. Any active infection involving eyeball adnexa Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment in the study eye Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye Other ocular conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids. Chronic concomitant therapy is defined as multiple doses taken daily for three or more consecutive days at any time within six months prior to screening or during the course of the study. Pregnant or breast-feeding women. Women of childbearing potential with either a positive pregnancy test result or no pregnancy test at baseline are excluded. Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study are excluded. (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly or diaphragm plus contraceptive sponge, foam, or jelly) Allergy to fluorescein Hypersensitivity to the active substance aflibercept or to any of the excipients (Polysorbate 20, Sodium dihydrogen phosphate, monohydrate, Disodium hydrogen phosphate, heptahydrate, Sodium chloride, Sucrose)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of intravitreal Aflibercept treatment on the visual outcome in patient with exsudative maculopathies such as Rap-lesions, PED, hemorrhagic CNV and PCV.;Secondary Objective: Retinal vessel diameters, retrobulbar flow velocities, anatomic changes in the macula region as assessed with a Spectralis-OCT, angiographic outcomes, macular pigment density;Primary end point(s): Visual acuity;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Retinal vessel diameters retrobulbar flow velocities anatomic changes in the macula region as assessed with a Spectralis-OCT angiographic outcomes macular pigment density;Timepoint(s) of evaluation of this end point: one year | — |
Countries
Austria
Contacts
Public ContactMUW
Universitätsklinik für Augenheilkunde und Optometrie, Medizinische Universität Wien
Outcome results
None listed