Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 13
- 主要终点
- Proliferative Vitreoretinopathy (PVR) grade CP (posterior - full thickness retinal folds in clock hours) 1 or higher [yes/no]
研究概览
简要总结
This study investigates the effectiveness of a simple treatment to prevent proliferative vitreoretinopathy (PVR).
Intraoperative intravitreal 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) is used as a prophylactic therapy in high-risk patients with primary rhegmatogenous retinal detachment (RRD). Our major motivation is to reduce the incidence of PVR in the group that receives the trial drug.
详细描述
Proliferative vitreoretinopathy (PVR) is a common cause for postoperative failure after vitreoretinal surgery for primary RRD. There is no standard-therapy to prevent PVR. Several attempts using chemotherapeutic agents have been undertaken to prevent this proliferation-process, but none of these was introduced into routine clinical practice.
Until recently, it has been challenging to identify patients with high risk for postoperative PVR formation. This is especially important, because in this trial treatment with the trial drug will be restricted to patients at high risk for PVR only.
Patients are assigned to the following treatment arms (1:1):
(A) Intraoperative adjuvant application of 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) via intraocular infusion during routine pars plana vitrectomy (PPV) in high-risk patients for proliferative vitreoretinopathy (PVR) with primary rhegmatogenous retinal detachment (RRD).
Versus:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Primary rhegmatogenous retinal detachment (< 4 weeks) in study eye
- •Scheduled for pars plana vitrectomy for retinal detachment repair without combined cataract surgery in study eye
- •Elevated protein levels in anterior chamber fluid (laser-flare value ≥ 15.0 pc/ms) in study eye
- •Female or male patient ≥ 18 years of age
- •Written informed consent
排除标准
- •Retinal detachment lasting > 4 weeks in study eye
- •Traumatic retinal detachment in study eye
- •Giant retinal tears in study eye (size > 3 clock hours)
- •Visual pre-existing PVR grade C in study eye
- •Retinal dystrophies in study eye
- •Scheduled for combined pars plana vitrectomy and cataract surgery for retinal detachment repair in study eye
- •Chronic inflammatory conditions in study eye
- •Active retinal vascular disease in study eye
- •Proliferative diabetic retinopathy in study eye
- •Manifest uveitis in study eye
- •Endophthalmitis in study eye
- •Perforating and non-perforating trauma in study eye
- •Malignant intraocular tumor in study eye
- •Aphakia in study eye
- •Uncontrolled glaucoma or ocular hypertension in study eye (intraocular pressure ≥ 30 mmHg despite IOP lowering therapy)
- •Previous intraocular surgery except uncomplicated cataract surgery with posterior chamber lens implantation in study eye
- •Cataract surgery in study eye ≤ 3 months ago
- •Previous retinal procedures (laserpexy, cryopexy, intravitreal gas-injection, anti-VEGF or corticosteroid-injection) in study eye ≤ 6 months
- •Other uncontrolled ophthalmologic disorders
- •Single eyed patients (BCVA of fellow eye > 1.0 log MAR, < 0.1 decimal, < 1/10 tenth, or < 6/60 Snellen fraction [m])
- •Evidence or history of alcohol, medication or drug dependency within the last 12 months.
- •Evidence or history (within the last 12 months) of neurotic personality, psychiatric illness that requires or required treatment, epilepsy or suicide risk.
- •Systemic disorders not compatible with adjuvant application of 5-FU and LMWH via intraocular infusion, or not compatible with the local or general anesthesia
- •Any therapy with immunosuppressant or chemotherapy ≤ 3 months and during the trial period
- •Participation in another trial of IMPs or devices parallel to, or less than 3 months before screening, or previous participation in this trial.
- •Known to or suspected of not being able to comply with the protocol.
- •Inability to understand the rationale of this trial or the study aim
- •Any dependency of the patient to the Investigator or the trial site, e.g. employees with direct involvement in the proposed trial or in other trials under the direction of this Investigator or trial site, as well as family members of the employees or the Investigator.
- •Positive urine pregnancy test, pregnancy or breastfeeding mother.
- •Women of child bearing potential without satisfactory contraception, i.e. hormonal contraceptives for at least 14 days before trial enrolment, IUD, double barrier (women of child bearing age must be counselled about the use of adequate contraception).
研究组 & 干预措施
Adjuvant therapy with 5-FU and LMWH
Intraoperative adjuvant application of 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) via intraocular infusion during routine pars plana vitrectomy (PPV) in high-risk patients for proliferative vitreoretinopathy (PVR) with primary rhegmatogenous retinal detachment (RRD).
干预措施: 5-fluorouracil and low molecular weight heparin (Drug)
Standard of care
Routinely used intraocular infusion with balanced salt solution (BSS) during routine pars plana vitrectomy (PPV) in high-risk patients for proliferative vitreoretinopathy (PVR) with primary rhegmatogenous retinal detachment (RRD).
干预措施: Placebo (Drug)
结局指标
主要结局
Proliferative Vitreoretinopathy (PVR) grade CP (posterior - full thickness retinal folds in clock hours) 1 or higher [yes/no]
时间窗: within 12 weeks
次要结局
- Occurrence of at least one drug-related adverse event that affects the study eye [yes/no](within 12 weeks)
- PVR grade CP 1 or higher [yes/no](within 6 weeks)
- Degree of PVR (PVR grade CA 1-12, PVR grade CP 1-12 (in clock hours))(within 6 weeks and 12 weeks)
- Best Corrected Visual Acuity (BCVA) measured by ETDRS charts(within 6 weeks and 12 weeks)
- PVR grade CA (anterior - full thickness retinal folds in clock hours) 1 or higher [yes/no](within 6 weeks and 12 weeks)
- Number and extent of surgical procedures necessary to achieve retinal reattachment(within 12 weeks)
- Retinal reattachment after primary intervention [yes/no](within 6 weeks and 12 weeks)
- Number of retinal re-detachments and if present due to PVR [yes/no](within 6 weeks and 12 weeks)