diabetic fluid accumulation in the macula diabetic macular edema
Conditions
Interventions
In this single-arm study all subjects will receive aflibercept according to the
EU label posology, i.e. 5 monthly intravitreal injections followed by
administrations every 8 weeks
Sponsors
INC Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Type 1 or 2 diabetes mellitus • Diagnosis of DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield on OCT) in the study eye • Decrease in vision determined to be primarily the result of DME in the study eye • BCVA in the study eye of ETDRS letter score 73 to 24 (This corresponds to a Snellen equivalent of approximately 20/40 to 20/320.)
Exclusion criteria
Exclusion criteria: A subject must not meet any of the following exclusion criteria, at screening and baseline as applicable, to be eligible for enrollment into this study. 1. Previous treatment with anti-angiogenic drugs in study eye (e.g. pegaptanib sodium, bevacizumab, ranibizumab) within the last 12 weeks 2. History of vitreoretinal surgery and/or including scleral buckling in the study eye 3. Use of long acting steroids, either periocular or intraocular, in the preceding 120 days 4. Any ocular or periocular infection in the preceding 4 weeks 5. Active proliferative diabetic retinopathy (PDR), current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment in the study eye 6. Aphakia in the study eye 7. Cataract surgery within 90 days 8. Yttrium-aluminum-garnet capsulotomy in the study eye within 30 days 9. Any other intraocular surgery within 90 days 10. Ocular inflammation (including trace or above) or history of uveitis in the study eye 11. Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or on OCT that is thought to affect central vision 12. Pre-retinal fibrosis involving the macula of the study eye 13. Structural damage to the center of the macula in the study eye that was 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 14. Filtration surgery for glaucoma in the past or likely to be needed in the future on the study eye 15. Intraocular pressure (IOP) >= 25 mmHg in the study eye 16. 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) 17. Myopia of a spherical equivalent prior to any possible refractive or cataract surgery of >= 8 diopters 18. Administration of systemic anti angiogenic agents within 180 days 19. Uncontrolled diabetes mellitus in the opinion of the investigator 20. Uncontrolled blood pressure (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg while subject is sitting confirmed in two separate measurements) 21. Presence of any contraindications indicated in the EU commission/locally approved label for aflibercept 22. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye 23. Allergy to fluorescein 24. Current treatment for a serious systemic infection 25. History of either cerebral vascular accident and/or myocardial infarction within 180 days 26. Renal failure requiring dialysis or renal transplant 27. 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 of an investigational drug, might affect interpretation of the results of the study, or renders the subject at high risk for treatment complications 28. Significant media opacities, including cataract, in the study eye that interferes with visual acuity, fundus photography or OCT imaging. 29. Breast-feeding women 30. Previous assignment to treatment during this study 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is * The change from baseline to Week 52 in the NEI VFQ 25 total score The calculation for NEI VFQ-25 sub-scale scores and total score will be performed according to the *NEI VFQ 25 Scoring Algorithm - August 2000*. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy variables include * The change from baseline to Week 52 in the NEI VFQ 25 near activities subscale * The change from baseline to Week 52 in the NEI VFQ 25 distant activities subscale * The change from baseline to Week 52 in BCVA (ETDRS letter score) * The change from baseline to Week 52 in CRT measured by OCT Proportion of subjects progressing to >= 61 ETDRS diabetic retinopathy severity scale (DRSS) as assessed by FPExploratory efficacy variables A complete list of variables to be analyzed for this study will be provided in the statistical analysis plan (SAP). The following safety variables will be assessed: • Adverse events • Vital signs • Ophthalmologic safety variables | — |
Countries
Netherlands
Outcome results
None listed