Exudative AMD MedDRA version: 19.1 Level: LLT Classification code 10025411 Term: Macular degeneration senile System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Eylea
Product Name: Aflibercept
Product Code: EMA/CHMP/299413/2012
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AFLIBERCEPT
CAS Number: 862111-32-8
Current Sponsor code
Sponsors
Kepler University Hospital, Institute of Ophthalmology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men and women aged over 50 years - If patient is a woman – post-menopausal (final menstruation period at least 3 years before Screening visit) - written informed consent for participation in the study - Scheduled for 3 consecutive intravitreal injections (4 week intervals) of aflibercept for treatment of exudative AMD in one eye - Subject is generally healthy with no current significant or a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder, as determined by the investigator’s clinical judgment through collection of medical history and performance of a physical examination. A significant disorder is defined as a disease or medical condition associated with impaired health status, requiring regular or current medical treatment and/or follow up. For the purposes of this study, an investigator may classify a medical condition as a nonsignificant disorder despite the fact that the subject receives treatment. Subjects having controlled Stage 1 hypertension (blood pressure of 140-159 mmHg systolic and/or 90-99 mmHg diastolic) are eligible for participation in this study. - Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Active exudative AMD requiring treatment of both eyes - Ocular surgery (including intravitreal injection) during the 3 months preceding the study - Vitrectomized eyes - History of diabetes - Smoking - Ametropia > 6 Dpt - Relevant ophthalmic diseases/conditions that could interfere with LSFG measurements (e.g. glaucoma, optic nerve head drusen, tilted disc, etc.) - Ocular infection or clinically significant inflammation - Opacities of the cornea (e.g. corneal scars, corneal oedema), the lens (e.g. LOCS-II grading > 2, posterior capsule opacification) or the vitreous (e.g. vitreous haemorrhage, asteroid hyalosis) - Patients who are not able to cooperate or with insufficient ability to fixate (tremor, nystagmus) - Blood donation in the 3 weeks preceding the study - Participation in a clinical trial in the 3 weeks preceding the study - Pre- or perimenopausal women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of intravitreal injection of aflibercept for the treatment of neovascular age-related macular degeneration on the ocular perfusion profile.;Secondary Objective: Not applicable;Primary end point(s): - Mean blur ratio (LSFG) - Pulse-waveform parameters (LSFG) ;Timepoint(s) of evaluation of this end point: post-injection: 10 minutes - 30 minutes - 60 minutes - 1 week - 1 month - 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Best spectacle-corrected distance visual acuity - Central retinal thickness (OCT) - Central choroidal thickness (OCT) - Systemic blood pressure - Intraocular pressure - Ocular perfusion pressure;Timepoint(s) of evaluation of this end point: post-injection: 10 minutes - 30 minutes - 60 minutes - 1 week - 1 month - 3 months | — |
Countries
Austria
Contacts
Public ContactStudy Coordinator
Kepler-University Hopsital
Outcome results
None listed