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NCT Number: NCT07774182

Intravitreal Triamcinolone and Biomarkers in Rhegmatogenous Retinal Detachment

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.

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Key information

Conditions

Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment Bone Diseases Bone Diseases, Developmental Camurati-Engelmann Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Osteochondrodysplasias Retinal Diseases Vitreoretinopathy, Proliferative

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital, Jakarta

Jakarta, DKI Jakarta, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Standard Vitrectomy

Procedure

Participants underwent standard surgical treatment for rhegmatogenous retinal detachment with proliferative vitreoretinopathy without preoperative intravitreal triamcinolone acetonide.

Triamcinolone Acetonide (TA)

Drug

Triamcinolone acetonide 2 mg was administered by intravitreal injection 5-7 days before vitrectomy.

Primary outcomes

  1. Change in Aqueous Humor TGF-β2, TGF-β3, MMP-2, and MMP-9 Levels

    Time frame: 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.

Secondary outcomes

  1. Change in Subretinal Fluid Optical Density Following Intravitreal Triamcinolone Acetonide

    Time frame: From before intravitreal triamcinolone acetonide administration to 5-7 days after administration, immediately before vitrectomy.

    Change in optical density of subretinal fluid before and after preoperative intravitreal administration of 2 mg triamcinolone acetonide in the intervention group. Optical density is assessed using optical coherence tomography (OCT) images and image analysis.

  2. Vitreous TGF-β2, TGF-β3, MMP-2, and MMP-9 Levels

    Time frame: At the time of vitrectomy; 5-7 days after intravitreal triamcinolone acetonide administration in the intervention group.

    Concentrations of TGF-β2, TGF-β3, MMP-2, and MMP-9 in vitreous samples collected during vitrectomy, comparing participants who received preoperative intravitreal triamcinolone acetonide with control participants who received standard surgical treatment without preoperative triamcinolone acetonide. Biomarker concentrations are measured using a multiplex assay and expressed in pg/mL.

  3. Vitreous Macrophage Count and Inflammatory Activity

    Time frame: At the time of vitrectomy.

    Macrophage populations and inflammatory activity in vitreous samples collected during vitrectomy are assessed using flow cytometry. Macrophage populations include total macrophages (CD68⁺), M0 macrophages (CD68⁺CD80-CD206-), M1 macrophages (CD68⁺CD80⁺), and M2 macrophages (CD68⁺CD206⁺). Macrophage inflammatory activity is assessed by the percentage of NF-κB-positive cells (NF-κB, %). Outcomes are compared between participants who received preoperative intravitreal triamcinolone acetonide and control participants who received standard surgical treatment without preoperative intravitreal triamcinolone acetonide.

  4. Vessel Diameter Index After Vitrectomy

    Time frame: Postoperative weeks 1, 2, and 4

    Vessel diameter index (VDI) is measured using optical coherence tomography angiography (OCTA) after vitrectomy. VDI is calculated by dividing vascular density by vascular length density. VDI is compared between participants who received preoperative intravitreal triamcinolone acetonide and control participants who received standard surgical treatment without preoperative triamcinolone acetonide.

Sponsors and collaborators

Lead sponsor

Anggun Rama Yudantha

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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