NCT05759884招募中不适用
Efficacy Analysis of Anti-vascular Endothelial Growth Factor (VEGF) Drugs Combined With Micropulse Laser in the Treatment of Diabetic Macular Edema
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- central macular thickness (CMT)
研究概览
简要总结
The goal of this clinical trial is to clarify the efficacy of anti-vascular endothelial growth factor (anti-VEGF) drugs combined with subthreshold micropulse laser (SML) therapy on retinal function and anatomical recovery in patients with diabetic macular edema (DME). The main questions it aims to answer are:
- To clarify the efficacy of anti-VEGF drugs combined with SML therapy on retinal function and anatomical recovery in DME patients.
- To explore the changes in visual acuity and optical coherence tomography angiography (OCTA) parameters before and after the treatment of DME with anti-VEGF drugs combined with SML, and further explore the changes in morphological characteristics of retinal microvessels and the potential treatment mechanism.
Participants will randomly be given Intravitreous injection of anti-VEGF drugs or anti-VEGF drugs combined with SML therapy. All participants will be followed up for 6 months after treatment.
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
- 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
- 否
入选标准
- •Patients with non-proliferative diabetic retinopathy (NPDR) meeting diagnostic criteria: the diagnosis can be made by fundus examination, fluorescein fundus angiography (FFA) and optical coherence tomography (OCT), which meet the clinical significant macular edema (CSME) definition criteria, i.e. hard exudation within 500μm of macular fovea with adjacent retinal thickening or edema within 500μm of macular fovea. Or the thickened area of the retina was > 1 disc diameter (D) and within 1 day of the fovea of the macula.
- •OCT examination showed a thickened CMT (≥200μm) without hyperplasia or scar
- •Standard logarithmic visual acuity charts measure the BCVA (LogMAR) range from 0.01 to 1.0
- •Control of glycosylated hemoglobin (HbA1c) ≤10% during follow-up
- •Patients voluntarily participate and sign informed consent
排除标准
- •Patients with severe corneal opacity, cataract and vitreous hemorrhage were found to be affected by OCTA examination by ophthalmic examination.
- •Patients with other eye diseases or other complications during follow-up, such as glaucoma (IOP>21mmHg), high myopia (≥-6.0D), and other fundus lesions, such as retinal detachment, vitreous macular traction, preretinal membrane, ischemic macular disease, optic neuritis and other diseases involving the retina and optic nerve.
- •Patients who have previously received intraocular surgery, vitreous macular traction syndrome, proliferative diabetic retinopathy (PDR) resulting in vitreous hemorrhage or local retinal detachment requiring surgical treatment, and patients with a history of eye trauma.
- •History of panretinal photocoagulation within 6 months prior to treatment or local/grille photocoagulation within 3 months prior to treatment.
- •History of intravitreal injection of any steroid within 6 months prior to treatment.
- •Patients with serious systemic diseases, such as cardiovascular and cerebrovascular diseases or hematopoietic system, patients who have undergone intracranial surgery or intracranial space-occupying lesions, and patients with mental disorders.
- •Can not cooperate with the ophthalmic examination or other reasons can not obtain the ideal OCTA image.
- •Pregnant, pregnant or lactating women and patients allergic to drugs.
- •Suspected or confirmed history of alcohol and drug abuse.
- •Patients who are participating in clinical trials of other drugs. If one of the above meets and can be excluded.
研究组 & 干预措施
anti-VEGF combined SML therapy group
Experimental
The patients were treated with intravitreal injection of anti-VEGF drugs and SML therapy.
干预措施: Anti-VEGF (Drug)
anti-VEGF combined SML therapy group
Experimental
The patients were treated with intravitreal injection of anti-VEGF drugs and SML therapy.
干预措施: subthreshold micropulse laser (Radiation)
anti-VEGF single therapy group
Active Comparator
Only intravitreal injection of anti-VEGF drugs was given to patients.
干预措施: Anti-VEGF (Drug)
结局指标
主要结局
central macular thickness (CMT)
时间窗: up to 6 months
CMT
次要结局
- best-corrected visual acuity (BCVA)(up to 6 months)
- superficial capillary vessel density (SVD)(up to 6 months)
- deep capillary vessel density (DVD)(up to 6 months)
- foveal avascular zone (FAZ)(up to 6 months)
- nonperfusion (NP)(up to 6 months)
研究者
研究点 (1)
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