Effect of Intravitreal Triamcinolone Acetonide on TGF-β2, TGF-β3, and Matrix Metalloproteinase Levels in Patients With Rhegmatogenous Retinal Detachment: A Study of Aqueous Humor and Vitreous Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Aqueous Humor TGF-β2, TGF-β3, MMP-2, and MMP-9 Levels
研究概览
简要总结
This prospective, randomized, controlled clinical study evaluates the effects of preoperative intravitreal triamcinolone acetonide (TA) on growth factors and inflammatory mediators in patients with rhegmatogenous retinal detachment (RRD) and proliferative vitreoretinopathy (PVR). Participants are assigned to either an intervention group receiving a 2-mg intravitreal injection of TA 5-7 days before vitrectomy or a control group receiving standard surgical treatment. The study evaluates TGF-β2, TGF-β3, MMP-2, and MMP-9 levels in aqueous humor and vitreous, macrophage cell counts and inflammatory activity in vitreous, subretinal fluid optical density assessed by optical coherence tomography, and vessel diameter index assessed by optical coherence tomography angiography after surgery.
详细描述
Rhegmatogenous retinal detachment (RRD) complicated by proliferative vitreoretinopathy (PVR) is associated with inflammatory and fibrotic processes that may contribute to retinal structural changes and surgical failure. Transforming growth factor beta (TGF-β) and matrix metalloproteinases (MMPs) are among the mediators involved in these processes, while macrophages may contribute to the inflammatory response associated with PVR.
This prospective, randomized, controlled clinical study evaluates the effects of preoperative intravitreal triamcinolone acetonide (TA) on growth factors and inflammatory mediators in patients with RRD and PVR. Eligible participants are allocated to receive either a 2-mg intravitreal injection of TA 5-7 days before vitrectomy or standard surgical treatment without preoperative TA.
The study evaluates TGF-β2, TGF-β3, MMP-2, and MMP-9 concentrations in aqueous humor and vitreous samples, as well as vitreous macrophage cell counts and inflammatory activity. Subretinal fluid optical density and postoperative vessel diameter index are also evaluated to assess retinal structural and vascular parameters.
The study aims to determine whether preoperative intravitreal TA is associated with changes in inflammatory and growth factor profiles, macrophage-related parameters, subretinal fluid optical density, and postoperative vascular parameters in patients with RRD and PVR.
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 (Outcomes Assessor)
盲法说明
Biomarker laboratory assessors and OCT image assessors were blinded to group allocation. The operating surgeon was not masked.
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
- •Adults aged 18 years or older with rhegmatogenous retinal detachment (RRD) and proliferative vitreoretinopathy (PVR) grade B or C.
- •No previous history of rhegmatogenous retinal detachment.
- •No requirement for surgical intervention other than treatment for RRD.
- •Willingness to participate in all study procedures and provide written informed consent.
排除标准
- •RRD with vitreous opacity precluding adequate fundus examination.
- •RRD caused by a giant retinal tear.
- •History of cataract surgery within the previous 3 months.
- •RRD associated with other ocular comorbidities.
- •Systemic disease that precludes vitrectomy.
- •History of ocular hypertension or glaucoma.
- •RRD with a cloudy lens requiring cataract surgery.
研究组 & 干预措施
Control
Participants received standard surgical treatment for rhegmatogenous retinal detachment with proliferative vitreoretinopathy without preoperative intravitreal triamcinolone acetonide.
干预措施: Standard Vitrectomy (Procedure)
Intravitreal Triamcinolone Acetonide
Participants received a 2-mg intravitreal injection of triamcinolone acetonide 5-7 days before vitrectomy for rhegmatogenous retinal detachment with proliferative vitreoretinopathy.
干预措施: Standard Vitrectomy (Procedure)
Intravitreal Triamcinolone Acetonide
Participants received a 2-mg intravitreal injection of triamcinolone acetonide 5-7 days before vitrectomy for rhegmatogenous retinal detachment with proliferative vitreoretinopathy.
干预措施: Triamcinolone acetonide (TA) (Drug)
结局指标
主要结局
Change in Aqueous Humor TGF-β2, TGF-β3, MMP-2, and MMP-9 Levels
时间窗: From before intravitreal triamcinolone acetonide administration to 5-7 days after administration, immediately before vitrectomy.
Change in aqueous humor concentrations of TGF-β2, TGF-β3, MMP-2, and MMP-9 before and after preoperative intravitreal administration of 2 mg triamcinolone acetonide in the intervention group. Biomarker concentrations are measured using a multiplex assay and expressed in pg/mL.
次要结局
- Change in Subretinal Fluid Optical Density Following Intravitreal Triamcinolone Acetonide(From before intravitreal triamcinolone acetonide administration to 5-7 days after administration, immediately before vitrectomy.)
- Vitreous TGF-β2, TGF-β3, MMP-2, and MMP-9 Levels(At the time of vitrectomy; 5-7 days after intravitreal triamcinolone acetonide administration in the intervention group.)
- Vitreous Macrophage Count and Inflammatory Activity(At the time of vitrectomy.)
- Vessel Diameter Index After Vitrectomy(Postoperative weeks 1, 2, and 4)
研究者
Anggun Rama Yudantha
Vitreoretinal Consultant
Indonesia University