prolipherative diabetic retinopathy
Conditions
Sponsors
Fakultní nemocnice Královské Vinohrady
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults = 18 years with type 1 or 2 diabetes mellitus. 2. Subjects with PDR secondary to diabetes mellitus ( confirmed on fluorescein angiography FA) 3. BCVA ETDRS letter score of 20/20 to 20/320 in the study eye 4. Willing and able to comply with clinic visits and study-related procedures. 5. Provide a signed informed consent form (ICF) 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: A subject who meets any of the following criteria will be excluded from the study. 1. Decrease in vision determined to be primarily the result of DME in the study eye 2. Laser quadrant or panretinal photocoagulation in the study eye 3. Previous treatment with anti-antiangiogenic drugs in study eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Baseline visit 4. Proliferative diabetic retinopathy in the study eye, with the inactive, regressed vessels 5. Any intraocular surgery within 28 days of Baseline visit in the study eye 6. Presence of tractional or rhegmatogenous retinal detachment in the study eye 7. Any active ocular or/and periocular inflammation or infection in the study eye at Screening or Baseline visits 8. Intraocular pressure (IOP) = 30 mmHg in the study eye at Screening or Baseline visits 9. Concurrent disease in the study eye, other than PDR, that could require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause) 10. Ocular media of insufficient quality to obtain fundus images and ERG (e.g., cataract, corneal opacity, severe vitreous haemorrhage) 11. Uncontrolled blood pressure defined as systolic value of >160 mmHg or diastolic value >100 mmHg eye at Screening or Baseline visits 12. Stroke or and/or myocardial infarction less than 3 months prior to Baseline visit 13. Pregnant or breast-feeding women. 14. Hypersensitivity to aflibercept or to fluorescein
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of aflibercept for intravitreal injection in comparison to laser treatment in subjects with prolipherative diabetic retinopathy (PDR);Secondary Objective: a)To evaluate changes of electroretinography (ERG) in subjects treated with aflibercept for intravitreal injection in comparison to laser treatment in subjects with prolipherative diabetic retinopathy (PDR) b)To evaluate the changes of contrast sensitivity (CS) in subjects treated with aflibercept for intravitreal injection in comparison to laser treatment in subjects with prolipherative diabetic retinopathy (PDR) c)To evaluate patient reported outcomes by NEI VFQ-25 changes from baseline to week 52 in subjects treated with aflibercept for intravitreal injection in comparison to laser treatment in subjects with prolipherative diabetic retinopathy (PDR) d)To evaluate other efficacy and safety endpoints for aflibercept for intravitreal injection in comparison to laser treatment in subjects with prolipherative diabetic retinopathy (PDR) ;Primary end point(s): Efficacy of therapy will be assessed by the change of ETDRS Diabetic Retinopathy Severity Score for proliferative diabetic retinopathy. Disease Severity LevelDerivation from ETDRS Levels Subjects in each arm will be divided in three groups according to their ETDRS Score Level at Week 52 compared to Baseline ETDRS Score Level: Group 1: worsening of ETDRS Score Level Group 2: maintaining the same ETDRS Score Level Group 3: improvement of ETDRS Score Level Number and percentage of subjects in each group in both arms will be determined. ;Timepoint(s) of evaluation of this end point: week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Changes in ERG parameters (ROD b-wave amplitude, dark-adapted Combined Response (CR) b-wave amplitude, CR a-wave, oscillatory potentials, cone single flash, and 30 Hz flicker responses) from Baseline to Week 52 b) Changes of Contrast Sensitivity Score from Baseline to Week 52 using Pelli –Robson charts. c) Changes in Patient Reported Outcomes using NEI VFQ-25 subscale from Baseline to Week 52. Standard National Eye Institute Visual Function Questionnaire-25 in Czech language. d) Change of intraocular pressure from Baseline to Week 52. e) Presence of iris neovascularisation at Week 52 compared to Baseline. f) Number of patients who needed rescue therapy due to progression of PDR regardless given treatment during the study. g) Proportion of subjects with stabilisation of PDR at Week 52 compared to Baseline as measured by ETDRS Severity Score based on the level of diabetes control h) Change of retinal and optic nerve disc neovascularisations size from Baseline to Week 52. ;Timepoint(s) of evaluation of this end point: week 52 | — |
Countries
Czech Republic
Contacts
Public ContactDepartment of clinical trials
Fakultní nemocnice Královské Vinohrady
Outcome results
None listed