EUCTR2014-004938-25-IT进行中（未招募）1 期
An open-label, randomized, active-controlled, parallel-group, Phase-3b study of the efficacy, safety and tollerability of three different treatment regimans of 2 mg aflibercept administered by intravitreal injections to subjects with diabetic macular edema (DME). - Efficacy and safety of three different aflibercept regimans in subjects with DME
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- BAYER AG
- 入组人数
- 463
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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, or
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