EUCTR2014-004938-25-GB进行中（未招募）1 期
An open-label, randomized, active-controlled, parallel-group, Phase-3bstudy of the efficacy, safety, and tolerability of three different treatmentregimens of 2 mg aflibercept administered by intravitreal injections tosubjects with diabetic macular edema (DME). - VIOLET
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
- 490
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
- •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
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,
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