An interventional study of Standard Vitrectomy and Triamcinolone acetonide (TA) in Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment, sponsored by Anggun Rama Yudantha. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Anggun Rama Yudantha · Not applicable, Interventional, and Treatment
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.
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.
43 studies on the registry are indexed under Vitreoretinopathy, Proliferative; 11 are open to participants now.
This study's enrollment of 60 is close to the median of 64 across 30 interventional studies indexed under Vitreoretinopathy, Proliferative.
Browse Vitreoretinopathy, Proliferative studies →This is the only study on the registry with Anggun Rama Yudantha as lead sponsor.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received standard surgical treatment for rhegmatogenous retinal detachment with proliferative vitreoretinopathy without preoperative intravitreal triamcinolone acetonide.
Procedure: Standard Vitrectomy
Participants received a 2-mg intravitreal injection of triamcinolone acetonide 5-7 days before vitrectomy for rhegmatogenous retinal detachment with proliferative vitreoretinopathy.
Procedure: Standard Vitrectomy · Drug: Triamcinolone acetonide (TA)
Participants underwent standard surgical treatment for rhegmatogenous retinal detachment with proliferative vitreoretinopathy without preoperative intravitreal triamcinolone acetonide.
Triamcinolone acetonide 2 mg was administered by intravitreal injection 5-7 days before vitrectomy.
Change in Aqueous Humor TGF-β2, TGF-β3, MMP-2, and MMP-9 Levels
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.
Time frame: From before intravitreal triamcinolone acetonide administration to 5-7 days after administration, immediately before vitrectomy.
Change in Subretinal Fluid Optical Density Following Intravitreal Triamcinolone Acetonide
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.
Time frame: 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
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.
Time frame: At the time of vitrectomy; 5-7 days after intravitreal triamcinolone acetonide administration in the intervention group.
Vitreous Macrophage Count and Inflammatory Activity
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.
Time frame: At the time of vitrectomy.
Vessel Diameter Index After Vitrectomy
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.
Time frame: Postoperative weeks 1, 2, and 4
Plan to share: No — Protection of patient data and privacy
Ran from May 2025 to primary completion in Feb 2026, 9 months.
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Studies of the drug tested here: Triamcinolone Acetonide
Vitreoretinopathy, Proliferative →