To evaluate if Aflibercept given every eighth week from start after an initial loading dose in age-related macular degeneration (AMD), is as effective as dosing as "Treat and extend" where treating intervalls are prolonged after stability in visual acuity is achieved. Followed for 18 months. The secondary objective is to evaluate the safety of Aflibercept assessed with ERG, and a quality of life questioner will be put to all patients at start and at follow-up after 18 months.
Conditions
Interventions
Trade Name: Aflibercept
Product Name: aflibercept
Product Code: SO1LAO5
Pharmaceutical Form: Intravitreal implant in applicator
Sponsors
Inst of OPhthalmology, Lund University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women age >50 years having an active subfoveal choroidal neovascularisation (CNV). Clinical indicated due to CNV with a visual impairment down to 0.1. Signed informed consent form • Corrected distance logMAR visual acuity more than 25 letters read on a standard ETDRS chart at 1 metre. • Age = 50 years of either gender • Any component of neovascularlesion (CNV, Blood, serious pigment epithelial detachment, elevated blocked fluorescence) involving the centre of the fovea. Eligibility criteria for study eye • Study eye must meet the following criteria for entry into the study: • Newly diagnosed, angiographically documented, previously untreated, active CNV lesion (i.e., leakage on fluorescein angiography AND subretinal, intraretinal, or sub-RPE fluid on OCT) secondary to age-related macular degeneration. • Best corrected visual acuity in the study eye, using e-ETDRS testing, between 20/25 and 20/320 (Snellen equivalent), inclusive. Only one eye will be enrolled in the Study. If both eyes are eligible, the patient and study ophthalmologist will select the eye for entry. • The CNV or sequela of the CNV (i.e., pigment epithelium detachment, subretinal or sub-RPE hemorrhage, blocked fluorescence, macular edema, or subretinal sub-RPE or intraretinal fluid) must involve the center of the fovea. • The total area of fibrosis must comprise less than 50% of the total lesion. • No previous treatment for CNV in the study eye Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Ocular concomitant / previous conditions / diseases • Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment • Active intraocular inflammation (grade trace or above) in either eye • Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye • History of uveitis in either eye • Structural damage within 0.5 disc diameter of the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques • Ocular disorders in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 24-month study period, including cataract, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia) • Uncontrolled glaucoma in either eye (IOP > 24 mmHg on medication or according to investigator’s judgment) • Neovascularization of the iris in either eye • Evidence of vitreomacular traction in either eye • Active proliferative diabetic retinopathy in the study eye • Patients who are monocular or have a BCVA score in the non-study eye (fellow eye) ? 24 letters (approximate Snellen equivalent of 20/320) at Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate if Aflibercept given every eighth week from start is as effective as given with an initial loading dose in age-related macular degeneration (AMD), after 6 months and after 18 months administered with a treat-and-extend regimen after the first 6 months. ;Secondary Objective: The secondary objective is to evaluate the safety of Aflibercept assessed with ERG, and a quality of life questioner will be put to all patients at a number of occasions throughout the study to evaluate these patients’ quality of life. ;Primary end point(s): Efficacy • Mean change in VA at 18 months (non-inferiority limit of 5 letters) • Change in retinal thickness on OCT ;Timepoint(s) of evaluation of this end point: After 18 months follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary: • ERG • Quality of Life questioner, VFQ 25 • Reading speed, eye movement,(central visual field?) ;Timepoint(s) of evaluation of this end point: After 18 months follow-up | — |
Countries
Sweden
Contacts
Public ContactEye clinic, University Hospital
Inst of OPhthalmology, Lund university
Outcome results
None listed