proliferative diabetic retinopathy
Conditions
Interventions
Trade Name: Eylea
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: AFLIBERCEPT
CAS Number: 862111-32-8
Current Sponsor code: BAY86-5321
Other descriptive name: AF
Sponsors
Department of Ophthalmology, MUW
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Active proliferative diabetic retinopathy (ETDRS severity 61 or higher) Diagnosis of type 1 or type 2 diabetes = 18 years of age Written informed consent to participate in the study 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 5
Exclusion criteria
Exclusion criteria: Intravitreal injection of any Anti-VEGF therapy in the study eye within 6 months prior to study inclusion Intraocular surgery, laser therapy (argon or YAG) in the study eye within 3 months prior to study inclusion Uncontrolled glaucoma Media opacities in the study eye Cardiovascular event within the past 6 months Allergy to study drug or to fluorescein retinal traction/detachment caused by proliferative membrane Active intraocular inflammation (grade trace or above) in the study eye, like infectious conjunctivitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis Systemic anti-VEGF or pro-VEGF treatment within four months prior to randomization or anticipated use during the study. Individual is expecting to move out of the area of the clinical center during the study period of 36 months.. pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the change in ETDRS diabetic retinopathy severity score from baseline to m12 and to m36 ;Secondary Objective: The secondary objectives also cover parameters related to vascular integrity and its improvement under repeated aflibercept treatment;Primary end point(s): The proportion of study eyes with DRSS improvements of 1 step or more The proportion of study eyes with DRSS improvement of 2 steps or more The proportion of study eyes with DRSS improvement of 3 steps or more The mean change (standard deviation) in DRSS;Timepoint(s) of evaluation of this end point: Month 12 and 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of study eyes exhibiting a specific feature (such as microaneurysms, vessel loops, capillary dropout, intraretinal microvascular abnormalities, venous beading, and potentially yet undescribed phenomena) Proportion of study eyes with regression of proliferative membrane Mean change in peripheral visual field Mean change in best corrected visual acuity Mean change in capillary vessel density Mean change in capillary fractal index Mean change in area of non-perfused capillaries Mean change in oxigen saturation in venules and areriols Characterization of cytokine levels in the aqueous humor and change following anti-VEGF treatment;Timepoint(s) of evaluation of this end point: monthly or annually, dependent on the imaging method applied | — |
Countries
Austria
Contacts
Public ContactClinical Trial Center Vienna
Department if Iohthalmology, MUW
Outcome results
None listed