Diabetic macular edema with central involvement MedDRA version: 16.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853
Conditions
Interventions
Product Name: VEGF Trap-Eye
Product Code: 80418745
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Aflibercept
Current Sponsor code: BAY86-5321
Other descriptive name: VEGF Trap-Eye
C
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults = 18 years with type 1 or 2 diabetes mellitus. 2. Subjects with DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield of optical coherence tomography [OCT]) in the study eye. 3. Decrease in vision determined to be primarily the result of DME in the study eye 4. Retinal thickness as assessed by OCT of =300 µm in the study eye. 5. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye. 6. Willing and able to comply with clinic visits and study-related procedures. 7. Provide a signed informed consent form (ICF). In Japan only, the informed consent form for a subject under the age of 20 years will require the co-signature of the subject’s legally authorized representative. 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 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 125
Exclusion criteria
Exclusion criteria: 1. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye. 2. History of vitreoretinal surgery and/or including scleral buckling in the study eye 3. Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1 4. More than 2 previous macular laser treatments in the study eye or, in the opinion of the investigator, the subject has no potential to benefit from laser treatments (eg, if too many laser treatments were applied in the past). 5. Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1 6. Previous treatment with anti-antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1 7. Active, proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR 8. History of idiopathic or autoimmune uveitis in the study eye 9. Cataract surgery within 90 days before Day 1 in the study eye 10. Aphakia in the study eye 11. Yttrium-aluminium-garnet (YAG) capsulotomy in the study eye within 30 days before Day 1 12. Any other intraocular surgery within 90 days of Day 1 in the study eye 13. Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or on OCT that is thought to affect central vision 14. Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment in the study eye 15. Pre-retinal fibrosis involving the macula in the study eye 16. Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia or organized hard exudates. 17. Ocular inflammation including trace or above in the study eye 18. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye 19. Filtration surgery for glaucoma in the past or likely to be needed in the future on the study eye 20. Intraocular pressure (IOP) = 25 mmHg in the study eye 21. Myopia of a spherical equivalent prior to any possible refractive or cataract surgery of = 8 diopters 22. Concurrent disease in the study eye, other than DME, that could compromise VA, 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) 23. Only 1 functional eye even if that eye is otherwise eligible for the study 24. Ocular media of insufficient quality to obtain fundus and OCT images 25. Current treatment for a serious systemic infection 26. Administration of systemic anti-angiogenic agents within 180 days before Day 1 27. Uncontrolled diabetes mellitus, as defined by HbA1c >12%. 28. Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg while subject is sitting) 29. History of either cerebral vascular accident and/or myocardial infarction within 180 days prior to Day 1 30. Renal failure requiring dialysis or renal transplant 31. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or renders the subject a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of intravitreally (IVT) administered VEGF Trap Eye in comparison to laser treatment in improving best corrected visual acuity (BCVA) in subjects with diabetic macular edema (DME) with central involvement ;Secondary Objective: To evaluate the safety of IVT administered VEGF Trap Eye in subjects with DME;Primary end point(s): The primary endpoint is the change from baseline of BCVA in ETDRS letters score at Week 52 compared to baseline (Day 1). ;Timepoint(s) of evaluation of this end point: 10.May 2013 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparisons between each of the VEGF Trap-Eye arms and the laser arm on the secondary efficacy endpoints will be performed only when the respective VEGF Trap-Eye arm demonstrates statistically significant difference from laser arm on the primary endpoint at week 52. To control the type I error, the secondary endpoints will be tested sequentially in the order described below: -Proportion of subjects who gain >/= 10 ETDRS letters from baseline to week 52 -Proportion of subjects who gain >/= 15 ETDRS letters from baseline to week 52 (as of Amd 2) -Proportion of subjects whith a >/= two-step improvement from baseline to Week 52 in the ETDRS diabetic retinopathy (DR) severity scale, as assessed by FP. (as of Amd 2) -Change in CRT from baseline to Week 52, as assessed on OCT. -NEI VFQ-25 near activities subscale change from baseline to Week 52 -NEI VFQ-25 distance activities subscale change from baseline to Week 52;Timepoint(s) of evaluation of this end point: 10.May 2013 | — |
Countries
Australia, Austria, Czech Republic, Denmark, Germany, Hungary, Italy, Japan, Spain
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed