Retinal angiomatous proliferation secondary to wet age related macular degeneration. MedDRA version: 17.0 Level: PT Classification code 10064930 Term: Age-related macular degeneration System Organ Class: 10015919 - Eye disorders MedDRA version: 17.0 Level: LLT Classification code 10069125 Term: Retinal angiomatous proliferation System
Conditions
Interventions
Trade Name: Eylea
Pharmaceutical Form: Injection
INN or Proposed INN: Aflibercept
CAS Number: 862111-32-8
Other descriptive name: AFLIBE
Sponsors
Doc. MUDr. Petr Kolár, PhD, Ocní klinika FN Brno
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Ability to provide written informed consent and comply with study assessments for the full duration of the study. 2) Men and women = 50 years old; women has to be postmenopausal 3) Definite characteristic signs of retinal angiomatous proliferation secondary to wet AMD as determined by clinical signs (retinal oedema, subretinal fluid, sub RPE fluid, retinal or subretinal hemorrhage) and angiography (minimally classic leakage on fluorescein angiography) 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: A subject who meets any of the following criteria will be excluded from the study. 1) Prior treatment with ranibizumab, bevacizumab, pegaptanib, verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye 2) Previous subfoveal focal laser photocoagulation involving the foveal centre in the study eye 3) Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding baseline 4) History of pars plana vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye 5) Previous participation in any studies of investigational drugs within 1 month preceding baseline 6) Subjects with scar or fibrosis making up >50% of the total lesion or scar, fibrosis, or atrophy involving the centre of the fovea in the study eye. 7) Subjects with clinical evidence of diabetic macular oedema, diabetic retinopathy or any retinal vascular disease other than AMD in either eye. 8) Subjects with other causes of CNV in the study eye. 9) Subjects with history of retinal detachment or treatment or surgery for retinal detachment in the study eye. 10) Subjects with intraocular pressure >25 mmHg despite treatment with antiglaucoma medication in the study eye. 11) Active intraocular, extraocular and periocular infection in either eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of intravitreal aflibercept by assessing the best corrected visual acuity (BCVA) in subjects with retinal angiomatous proliferation (RAP) secondary to wet AMD.;Secondary Objective: To assess other efficacy parameters of intravitreal aflibercept in subjects with retinal angiomatous proliferation (RAP) secondary to wet AMD.;Primary end point(s): The primary variable is change from baseline in the best corrected visual acuity score (BCVA) on the ETDRS chart at 12 months.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 6 months 12 months 24 months ; Secondary end point(s): Secondary variables are: 1) Proportion of subjects with vision loss of 15 letters in the best corrected visual acuity score on the ETDRS chart at 6, 12 and 24 months compared to baseline 3) Change from baseline in the best corrected visual acuity score on the ETDRS chart at 6 and 24 months. 4) Proportion of subjects who lose > 15 letters of vision in the best corrected visual acuity score on the ETDRS chart at 6, 12 and 24 months from baseline 5) Change from baseline to 12 and 24 months in CRT as measured by OCT 6) Proportion of subjects who show complete resolution of FA leakage at 12 and 24 months 7) Mean change from baseline in total NEI VFQ-25 score at 12 and 24 months 8) Number of injections during the study period | — |
Countries
Czech Republic
Contacts
Public ContactPetr Kolár
Doc. MUDr. Petr Kolár, PhD, Ocní klinika FN Brno
Outcome results
None listed