Response to Aflibercept After Previous Intravitreal Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percent change in Best-Corrected Visual Acuity (BCVA)
研究概览
简要总结
Age-related macular degeneration (AMD) and diabetic retinopathy are among the most common disorders causing visual disability in elderly people. AMD leads to dysfunction and loss of photoreceptors in the central retina. Neovascular AMD (nAMD) affects visual function early in the disease process.
The purpose of the study is to evaluate the effect of switching from ranibizumab therapy to the current routine therapy using aflibercept in eyes with treatment naive, recurrent or persistent nAMD, treatment naive diabetic retinopathy and pretreated diabetic retinopathy.
20 patients with recurrent or persistent nAMD, previously treated with intravitreal ranibizumab for up to one year will be included in this trial. Patients will be examined in monthly intervals over 12 months follow-up.
Examinations carried out will include: Best-corrected visual acuity (BCVA) using ETDRS charts at 4m distance, Reading Performance (RP), Standard ophthalmic examinations (SOE incl. funduscopy and applanation tonometry), Optical coherence tomography (OCT), Autofluorescence fundus image (AF) & red-free autofluorescence fundus image (RF), Color fundus photography (CFP), Fluorescein angiography and indocyaningreen angiography (FLA/ICG), Microperimetry (MP), as well as Non-invasive OCT based optical angiography (AngioVue).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 50 years
- •Patients who have been treated with ranibizumab due to wet age-related macular degeneration for up to one year
- •BCVA >= 20/400 in the study eye using ETDRS
- •Willingness and ability to comply with regular visits
- •Signed informed consent
排除标准
- •Any surgical treatment of the eye within 3 months prior to baseline in the study eye
- •History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation)
- •Aphakia or absence of the posterior capsule (excluding YAG-capsulotomy) in the study eye
- •Retinal pigment epithelial tear involving the macula in the study eye
研究组 & 干预措施
AMD patients previously teated with Lucentis
Adults ≥ 50 years; Patients who have been treated with ranibizumab due to wet age-related macular degeneration for up to one year; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS; Willingness and ability to comply with regular visits; Signed informed consent form;
The patient can take his medicine in the prescribed manner. The prescribed drugs do not constitute an exclusion criteria.
干预措施: Aflibercept (Drug)
treatment naive AMD patients
Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;
干预措施: Aflibercept (Drug)
DME patients previously teated with Lucentis
Adults ≥ 50 years; Patients who have been treated with ranibizumab due to DME for up to one year; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;
干预措施: Aflibercept (Drug)
treatment naive DME patients
Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;
干预措施: Aflibercept (Drug)
结局指标
主要结局
Percent change in Best-Corrected Visual Acuity (BCVA)
时间窗: After one year compared to baseline
Anatomic changes in the macula as assessed with OCT (central retinal thickness, morphologic changes, fundus photos)
时间窗: after one year compared to baseline
次要结局
- Number of retreatments(after one year)
研究者
Stefan Sacu
Prof. PD. Dr.
Medical University of Vienna