EUCTR2013-000120-33-PT进行中（未招募）1 期
An open-label, randomized, active-controlled, parallel-group, Phase-3b study of the efficacy, safety, and tolerability of 2 mg aflibercept administered by intravitreal injections using two different treatment regimens to subjects with neovascular age-related macular degeneration (nAMD). - AZURE
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
- 330
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
- •First set of inclusion criteria:
- •All of the following criteria must have been met at the initial start of
- •aflibercept treatment (i.e. start of aflibercept treatment prior to this
- •study) for a subject to be eligible for this study.
- •1. Subject had primary subfoveal choroidal neovascularization (CNV)
- •lesions secondary to nAMD, including juxtafoveal lesions that affect the
- •fovea, as evidenced by FA of the study eye within 4 weeks before the
- •initiation of aflibercept treatment.
- •2. The area of CNV occupied at least 50% of the total lesion within 4
- •weeks before the initiation of aflibercept treatment.
- •3. Documented BCVA was 20/40 to 20/320 (comparable to a letter score
- •of 73 to 25) in the study eye at the initiation of treatment (the initial
- •BCVA of the study eye before treatment initiation must be documented
- •as Snellen equivalent in the electronic case report form [eCRF]).
- •Second set of inclusion criteria:
- •All of the following criteria must be met at the time of screening for
- •participation in this study for a subject to be eligible for this study.
- •4. Signed written informed consent
- •5. Men or women = 51 years of age
- •6. The subject's history of aflibercept treatment meets ALL of the
- •a) Treatment in the study eye was initiated with three monthly (-1
- •week/+2 weeks) doses of 2 mg aflibercept and improvements of visual
- •and anatomic outcomes were observed
- •b) Following the above initiation phase, the intervals between
- •treatments were between 6 weeks and 12 weeks (one exception will be
- •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 2 months (+/- 10 days) before the first treatment in this study
- •e) Total prior treatment duration with aflibercept (i.e. from first
- •treatment to randomization into this study) was =12 months
- •7. Subject is willing, committed, and able to return for ALL clinic visits
- •and complete all study-related procedures.
- •8. Women and men of reproductive potential must agree to a method of
- •highly effective contraception (as defined by the Clinical Trial
- •Facilitation Group [CTFG] from 15 SEP 2014):
- •Combined (estrogen and progestogen containing) hormonal
- •contraception associated with inhibition of ovulation:
- •o intravaginal
- •o transdermal
- •Progestogen-only hormonal contraception associated with inhibition of
- •o injectable
- •o implantable
- •Intrauterine device
- •Intrauterine hormone-releasing system
- •Bilateral tubal occlusion
- •Vasectomized partner
- •Sexual abstinence
- •Alternatively women and men of reproductive potential can also use two
- •acceptable methods of contraception (as defined by the CTFG from 15
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排除标准
- •First set of exclusion criteria:
- •A subject who has met any of the following criteria at the initial start of
- •aflibercept treatment (i.e. start of aflibercept treatment before this
- •study) will be excluded from this study.
- •1. Any prior or concomitant therapy with an investigational or approved
- •agent to treat neovascular AMD in the study eye.
- •2. Total lesion size > 12 disc areas (30.5 mm2, including blood, scars
- •and neovascularization) as assessed by FA in the study eye
- •3. Subretinal hemorrhage that was:
- •a) 50% or more of the total lesion area, or
- •b) if the blood was under the fovea, and
- •c) the blood under the fovea was 1 or more disc areas in size in the
- •4. Scar or fibrosis making up more than 50% of the total lesion in the
- •5. Scar, fibrosis, or atrophy involving the center of the fovea in the study
- •6. Presence of retinal pigment epithelial tears or rips involving the
- •macula in the study eye.
- •7. Causes of CNV other than AMD in the study eye.
- •Second set of exclusion criteria:
- •A subject who meets any of the following criteria at the time of
- •screening for participation in this study will be excluded from this study.
- •8. Subjects who currently meet any of the first set of exclusion criteria
- •with the exception of prior treatment with aflibercept
- •9. Any prior ocular (in the study eye) or systemic treatment or surgery
- •for neovascular AMD, except dietary supplements, vitamins and IVT
- •injections of aflibercept, during the time (i.e. at least 12 months)
- •between initiation of aflibercept treatment and randomization into this
- •10. Any prior treatment with anti-VEGF therapy in the study eye, with
- •the exception of IVT injections of aflibercept, during the time (i.e. at
- •least 12 months) between initiation of aflibercept treatment and
- •randomization into this study
- •11. Prior systemic anti-VEGF therapy, investigational or approved, within
- •the last 15 months prior to randomization
- •12. Any vitreous hemorrhage within 4 weeks before randomization in the
- •13. Active intraocular, extraocular and periocular inflammation or
- •infection in either eye.
- •14. Any ocular or periocular infection within 4 weeks of randomization in
- •15. Any serious adverse event related to aflibercept during prior
- •16. Any history of allergy or hypersensitivity to povidone iodine.
- •17. Known serious allergy or hypersensitivity to the fluorescein sodium
- •for injection in angiography
- •18. Presence of any contraindications indicated in the EU
- •commission/locally approved label for aflibercept: Hypersensitivity to
- •the active substance aflibercept or to any of the excipients; active or
- •suspected ocular or periocular infection; active severe intraocular
- •inflammation
- •19. Prior vitrectomy in the study eye
- •20. History of vitreomacular traction in the study eye
- •21. History of retinal detachment or treatment or surgery for retinal
- •detachment in the study eye.
- •22. Any history of macular hole of stage 2 and above in the study eye
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研究者
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