Diabetic macular edema (DME) MedDRA version: 19.0 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 10015919 - Eye disorders MedDRA version: 19.0 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be met at screening and baseline for this study 1. Adults of either sex, = 18 years of age 2. The subject’s history of aflibercept treatment meets all of the following: a. Treatment in the study eye was initiated with five monthly (-1 week / +2 weeks) doses of 2 mg aflibercept and improvements of visual and anatomic outcomes were observed and documented. b. Following the above initiation phase, the intervals between treatments were between 6 weeks and 12 weeks (one exception will be allowed). c. The interval between the last two pre-study injections was = 8 weeks, and visual and anatomic outcomes have been stable over this interval. d. The subject received the last IVT injection of aflibercept in the study eye 8 weeks (±10 days) before the first planned treatment / randomization in this study. e. Total prior treatment duration with aflibercept (i.e. from first aflibercept treatment ever to enrollment into this study) was 1 year or longer. 3. Willingness and ability to comply with clinic visits and study-related procedures 4. Women and men of reproductive potential must agree to a method of highly effective contraception (as defined by the Clinical Trials Facilitation group [CTFG] from 15 SEP 2014) 5. Negative pregnancy test (serum test at screening; urine dip stick test at baseline; women of childbearing potential only) 6. Signed written informed consent To be met at initiation of pre-study aflibercept treatment: 7. Type-1 or -2 diabetes mellitus 8. 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 9. Decrease in vision determined to be primarily the result of DME in the study eye 10. 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. 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 367 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 123
Exclusion criteria
Exclusion criteria: At initiation of pre-study aflibercept treatment 1. Previous treatment with anti-angiogenic drugs in study eye (e.g. pegaptanib sodium, bevacizumab, ranibizumab or aflibercept) within the last 12 weeks before initiation of aflibercept pre-study treatment. At all of the following time points: ? Initiation of pre-study aflibercept treatment ? Screening for this study ? Baseline for this study 2. History of vitreoretinal surgery and/or including scleral buckling in the study eye 3. Prior treatment of the study eye with ? - Long acting steroids, either periocular or intraocular, in the preceding 120 days or ?- Iluvien® intravitreal implant at any time 4. Active proliferative diabetic retinopathy (PDR), current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment in the study eye 5. Aphakia in the study eye 6. Cataract surgery within 90 days before aflibercept treatment in the study eye 7. Yttrium-aluminum-garnet capsulotomy in the study eye within 30 days before aflibercept treatment 8. Any other intraocular surgery within 90 days of aflibercept treatment in the study eye 9. Ocular inflammation (including trace or above) or history of uveitis in the study eye 10. Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or on OCT that was thought to affect central vision 11. Pre-retinal fibrosis involving the macula of the study eye 12. 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 13. 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 advanced glaucoma, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause) 14. Myopia of a spherical equivalent prior to any possible refractive or cataract surgery of = 8 diopters in the study eye 15. Administration of systemic anti angiogenic agents within 180 days before aflibercept treatment 16. Uncontrolled diabetes mellitus as defined by hemoglobin (Hb)A1c > 12.0% 17. 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) 18. Presence of any contraindications indicated in the EU commission/locally approved label for aflibercept At all of the following time points ? Screening for this study ? Baseline for this study. 19. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye 20. Any ocular or periocular infection in the preceding 4 weeks in either eye 21. Filtration surgery for glaucoma in the past or likely to be needed in the future on the study eye 22. Uncontrolled glaucoma (defined as intraocular pressure [IOP] > 25 mmHg despite treatment with antiglaucoma medication) in the study eye 23. Allergy or hypersensitivity to fluorescein 24. Current treatment for a serious systemic infection 25. History of either cerebral vascular accident and/or myocardial infarction within 180 days before aflibercept treatment 26. Renal failure requiring dialysis or renal transplant 27. History of other disease, metabolic dysfunction, physical examination finding,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Change in ETDRS BCVA letter score for the study eye from baseline to Week 52;Timepoint(s) of evaluation of this end point: After 52 weeks of randomized treatment;Main Objective: The primary objective of this study is to evaluate the efficacy of long-term treatment with 2 mg aflibercept via different intravitreal (IVT) treatment regimens to subjects with DME pre-treated for at least one year. ;Secondary Objective: The secondary objective is to assess the safety and tolerability of different treatment regimens of aflibercept in this population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy variables are: ? Change from baseline in ETDRS BCVA letter score for the study eye to Week 100 ? Change from baseline in CRT in the study eye to Week 52 ? Change from baseline in CRT in the study eye to Week 100;Timepoint(s) of evaluation of this end point: After 52 and 100 weeks of randomized treatment | — |
Countries
Austria, Canada, Czech Republic, France, Germany, Hungary, Italy, Lithuania, Poland, Portugal, Slovakia, Spain, Switzerland, United Kingdom
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed