ETDRS Panretinal Photocoagulation (PRP) Combined With Intravitreal Ranibizumab (IVR) Versus Retinal Photocoagulation Targeted to Ischemic Retina Combined With IVR for the Treatment of Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 主要终点
- Fluorescein leakage area of active new vessels (FLA)
研究概览
简要总结
Purpose: To compare panretinal photocoagulation (PRP) as described in ETDRS Study combined with intravitreal injection of ranibizumab (IVR) (ETDRS-PRP group) and retinal photocoagulation targeted to ischemic retina combined with IVR (ISQ-RP group) in patients with proliferative diabetic retinopathy (PDR).
Design: Randomized prospective clinical trial. Methods: Patients with PDR were assigned to receive either PRP plus IVR (20 eyes) or retinal photocoagulation targeted to ischemic areas plus IVR (20 eyes). ETDRS best-corrected visual acuity (BCVA), central subfield macular thickness (CSFT) measured by optical coherence tomography (OCT) were performed at baseline and every 4 weeks through week 48. Area of fluorescein leakage from active new vessels (FLA) was measured every 12 weeks. Full-field electroretinography (ERG) was recorded at baseline and after 3 months.
详细描述
This parallel clinical trial was approved by the local Research Ethics Committee, and all subjects gave written informed consent to participate. Between August 2014 and July 2016, all adult patients with treatment-naive PDR and a best-corrected visual acuity (BCVA) better than 20/800 evaluated at our facility were invited to participate in the study.
During the recruitment phase, twenty-three consecutive patients who met the inclusion and exclusion criteria were enrolled into the study. At baseline visit, each patient underwent detailed ophthalmologic assessment including BCVA measurement according to standardized ETDRS refraction protocols using modified ETDRS cards 1, 2 and R; applanation tonometry; slit-lamp biomicroscopy examination under mydriasis (including classification of crystalline lens opacity status using the Lens Opacities Classification System - LOCS III) (13); and indirect funduscopic examination. Digital ocular stereoscopic fundus photographs (TRC-50DX - IMAGEnet; Topcon, Tokyo, Japan), wide field fluorescein angiography and spectral domain optical coherence tomography (SD-OCT) (HRA-OCT, Heidelberg, Germany) were also performed.
Randomization and treatment groups
Patients were randomly assigned using a computer-generated sequence, to one of the following two treatment groups:
ETDRS-PRP Group: patients were treated in two sessions (week 0 and week 2) of 800-900 shots, for a total of 1600-1800 shots with a shot duration of 100 ms and power modulated in order to generate moderately white spots on the retina.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients with treatment-naive PDR and a best-corrected visual acuity (BCVA) better than 20/800
排除标准
- •Presence of advanced PDR, i.e., vitreous hemorrhage that would prevent documentation of the fundoscopic examination or administration of PRP, or presence of traction retinal detachment;
- •presence of ring-shaped retinal neovascularization extending along both temporal arcades and the optic disc;
- •an abnormality of the vitreoretinal interface in the macular region that would lead the investigator to consider the necessity of pars plana vitrectomy;
- •intravitreal injection of corticosteroids or other antiangiogenic drugs during the prior 6 months;
- •inability of patient to fixate and perform reliable automated static perimetry;
- •cataract surgery during the prior 3 months;
- •history of pars plana vitrectomy or scleral buckle;
- •acute ocular infection;
- •allergy to fluorescein;
- •medical or psychological conditions that would prevent the patient from giving written informed consent or completing the study;
- •significant uncontrolled disease that, in the opinion of the investigator, would prevent the patient from completing the study;
- •participation in another clinical study during the previous 30 days.
研究组 & 干预措施
ETDRS-PRP group
Patients with proliferative diabetic retinopathy submitted to panretinal photocoagulation (PRP) as described in ETDRS Study combined with intravitreal injection of ranibizumab (IVR) (ETDRS-PRP group) if angluofluoresceinography demonstrated the presence of actively leaking retinal neovascularization or SD-OCT demonstrated a CSFT of more than 300 µm.
干预措施: ETDRS-PRP group (Procedure)
ISQ-RP group
Patients with proliferative diabetic retinopathy submitted to retinal photocoagulation targeted to ischemic retina combined with intravitreal injection of ranibizumab (IVR) if angluofluoresceinography demonstrated the presence of actively leaking retinal neovascularization or SD-OCT demonstrated a CSFT of more than 300 µm.
干预措施: ISQ-RP (Procedure)
结局指标
主要结局
Fluorescein leakage area of active new vessels (FLA)
时间窗: 48 weeks
Compare the Area of fluorescein leakage from active new vessels in both groups in mm2 measured by wide field fluorescein angiography (Optomap 200TX; Optos PLC., Dunfermline, Scotland, United Kingdom)
次要结局
- Best-corrected visual acuity (BCVA)(48 weeks)
- Central subfield thickness (CSFT)(48 weeks)
- Number of Ranibizumab Intravitreal Injections(48 weeks)
- Electroretinography(48 weeks)