EUCTR2012-005500-18-GB进行中（未招募）1 期
A pharmacokinetic study: ranibizumab, aflibercept and the effect of vitrectomy - VITCLEAR Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 62
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
入选标准
- •Adults of either sex aged 55 years and older
- •Active neovascular AMD in the study eye
- •Intravitreal dose of 0.5 mg ranibizumab or 2 mg aflibercept required, as per current clinical guidelines
- •Venous access that is sufficient to allow easy blood sampling on a frequent basis
- •Able to give written consent
- •Willingness to comply with all study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 62
排除标准
- •Myopia greater than 8 dioptres in the study eye
- •Axial length of eye under 20mm or over 26mm
- •Aphakia in study eye
- •Pseudophakia with a defect in the posterior capsule
- •Glaucoma in study eye
- •Current renal dialysis
- •Presence of inflammatory eye conditions, such as uveitis, or systemic conditions likely to elevate CRP.
- •Intraocular surgery within 6 months of enrolment, except for routine phacoemulsification cataract surgery that may occur within 4 months of enrolment
- •Current treatment for wet age-related macular degeneration with an intravitreal agent other than ranibizumab or aflibercept in the study eye. Patients expected to change their anti-VEGF agent during the sampling period are also excluded.
- •Known significant allergy to ranibizumab or aflibercept
- •Participants who, in the opinion of the Investigator, would not be willing or able to comply with the study protocol or provide informed consent.
- •Patients with severe anaemia
- •Patients who have received anti-VEGF therapy in either eye within 8 weeks of enrolment, or who are likely to require anti-VEGF treatment in the fellow eye during the course of venous sampling. Note that the final venous sample at 4 weeks can be undertaken on the same day as an anti-VEGF injection, but must be taken prior to any injection.
- •Patients presently taking any topical (skin or eye), periocular, intraocular, local or systemic treatment with immunosuppressive or anti-inflammatory agents, such as steroids, steroid sparing agents, and NSAIDs. Patients who have received any of these agents within 2 months prior to enrolment are also excluded, as are those thought likely to receive these medications during the course of venous sampling.
研究者
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