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临床试验/NCT02865031
NCT02865031已完成1 期

Intravitreal Decorin Preventing Proliferative Vitreoretinopathy in Perforating Injuries: a Pilot Study.

Cairo University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
15
试验地点
1
主要终点
Electrophysiological tests ERG a and b implicit time and latency

研究概览

简要总结

Purpose: To determine the safety, tolerability, and efficacy of human recombinant decorin protein, a transforming growth factor ß (TGFß) inhibitor in preventing proliferative vitreoretinopathy (PVR) in patients with perforating globe injuries.

Methods: This is a prospective, single-center, open-label, interventional case series. A single intravitreal injection of decorin 200ug (n=4) and 400ug (n=8) was given within 24 hours of injury. Pars plana vitrectomy with silicone oil injection was done if indicated. ERG was done before injections, at day 10, and 3 months. Serial plasma decorin levels were assessed before injections, day 3, 5, and 10 post-injection. Clinical assessment included globe survival, retinal attachment rate, and PVR evaluation.

详细描述

This is prospective, single-center, open-label, interventional case series. Twelve patients with open globe injuries presenting to the causality department at Kasr Al Ainy Teaching Hospital, Cairo University, were enrolled in our study. Those patients were assigned to Ocular Trauma Score category 1 or 2 in which the visual prognosis after treatment is poor (Category 1 prognosis: 74% no light perception, 15% light perception to hand movements, Category 2 prognosis: 27% no light perception, 26% light perception to hand movements) (31).

An informed consent was obtained from the participant prior to the conduct of any study procedure. The participant was adequately informed about the study, understood risks, benefits and alternative treatments, and voluntarily agreed to participate in the study. He / She was given ample time to consider participation and had his / her questions addressed in a satisfactory manner before agreeing to participate and signing the informed consent form. Participants were free to choose to withdraw from the study at any time without any responsibility, even if the study has not been completed.

Pre-operative Evaluation: 1. Baseline systemic examination: including clinical evaluation, complete blood picture, liver function tests and kidney function tests. 2. Full ocular examination: All patients were subjected to complete ophthalmological examination including: Best corrected visual acuity (according to the Snellen VA chart). Slit lamp examination. 3. CT scan (Sytec and BrightSpeed; GE Healthcare, Milwaukee, Wis): Unenhanced CT of the orbits was performed; axial, coronal and sagittal views with contiguous 2-mm-thick sections.

  1. Full Field ERG using a full field flash Ganzfeld stimulator (Roland Consult, Electrophysiologic Diagnostic Systems, Wiesbaden, Germany): The ISCEV-ERG GF program was used to record standard ERGs. All responses were differentially amplified, displayed on an oscilloscope, digitized and stored on a compact disc. An adjustable voltage window was used to reject records contaminated by artifacts.

Dark adapted ERG responses were obtained after a minimum of 30 minutes of dark adaptation and included an isolated rod, standard flash (maximal) response, and oscillatory potentials. Light adapted responses included a single white flash and 30-Hz flicker. ERG amplitudes and implicit time values were measured according to recommendations by the International Society for Clinical Electrophysiology of Vision.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: > 18 years old
  • Perforating Ocular Injuries zone 2 and
  • ERG of the affected eye was at least 50% of the unaffected fellow eye.

排除标准

  • No concomitant ocular disease.
  • No pervious ocular surgery.
  • No systemic organ failure.

研究组 & 干预措施

Decorin

Experimental

Intravitreal injection of 200-400 ug of Decorin.

干预措施: Decorin (Drug)

结局指标

主要结局

Electrophysiological tests ERG a and b implicit time and latency

时间窗: 3 months

次要结局

  • Scar tissue formation graded 0-4 grades(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamer Ahmed Macky

Professor

Cairo University

研究点 (1)

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