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Proliferative Vitreoretinopathy in Rhegmatogenous Retinal DetachmentNCT07774182

Intravitreal Triamcinolone and Biomarkers in Rhegmatogenous Retinal Detachment

A study testing Standard Vitrectomy and Triamcinolone acetonide (TA) in people with Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment, run by Anggun Rama Yudantha at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Standard Vitrectomy and Triamcinolone acetonide (TA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteIndonesia
Study dates
6 May 2025to 18 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • Department of Ophthalmology, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital, Jakarta

    Jakarta, DKI Jakarta

Other trials in Indonesia

About this study

Official 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

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.

Read the detailed description

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.

Being tested
Standard Vitrectomy, Triamcinolone acetonide (TA)
Keywords
Rhegmatogenous retinal detachment, Proliferative vitreoretinopathy, Intravitreal triamcinolone acetonide, TGF-beta, Matrix metalloproteinases, MMP-2, MMP-9, Macrophages, Vitreous biomarkers, Aqueous humor biomarkers
Medical subject headings
Vitreoretinopathy, Proliferative, Camurati-Engelmann Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard VitrectomyProcedure or surgery

    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.

Study groups in NCT07774182
Study groupRoleWhat they receive
ControlActive comparatorParticipants received standard surgical treatment for rhegmatogenous retinal detachment with proliferative vitreoretinopathy without preoperative intravitreal triamcinolone acetonide.
Receives: Procedure: Standard Vitrectomy
Intravitreal Triamcinolone AcetonideExperimentalParticipants received a 2-mg intravitreal injection of triamcinolone acetonide 5-7 days before vitrectomy for rhegmatogenous retinal detachment with proliferative vitreoretinopathy.
Receives: Procedure: Standard Vitrectomy; Drug: Triamcinolone acetonide (TA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (4)
  1. 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.

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

  2. 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.

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

  3. 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.

    Measured: At the time of vitrectomy.

  4. 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.

    Measured: Postoperative weeks 1, 2, and 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2026
  2. Study start6 May 2025
  3. Primary completion18 Feb 2026
  4. Study completion18 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07774182
Sponsor's protocol ID
KET-1409/UN2.F1/ETIK/PPM.OO.02
Status last verified
Aug 2026
First submitted
15 Aug 2026
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Protection of patient data and privacy

Publications

  • Leshno A, Barak A, Loewenstein A, Weinberg A, Neudorfer M. Optical Density of Subretinal Fluid in Retinal Detachment. Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5432-8. doi: 10.1167/iovs.15-16952.

    PubMed 26284548
  • Symeonidis C, Papakonstantinou E, Souliou E, Karakiulakis G, Dimitrakos SA, Diza E. Correlation of matrix metalloproteinase levels with the grade of proliferative vitreoretinopathy in the subretinal fluid and vitreous during rhegmatogenous retinal detachment. Acta Ophthalmol. 2011 Jun;89(4):339-45. doi: 10.1111/j.1755-3768.2009.01701.x. Epub 2009 Sep 18.

    PubMed 19764916
  • Webster L, Chignell AH, Limb GA. Predominance of MMP-1 and MMP-2 in epiretinal and subretinal membranes of proliferative vitreoretinopathy. Exp Eye Res. 1999 Jan;68(1):91-8. doi: 10.1006/exer.1998.0585.

    PubMed 9986746
  • Caban M, Owczarek K, Lewandowska U. The Role of Metalloproteinases and Their Tissue Inhibitors on Ocular Diseases: Focusing on Potential Mechanisms. Int J Mol Sci. 2022 Apr 12;23(8):4256. doi: 10.3390/ijms23084256.

    PubMed 35457074
  • Hsiao CC, Chang YC, Hsiao YT, Chen PH, Hsieh MC, Wu WC, Kao YH. Triamcinolone acetonide modulates TGF-beta2-induced angiogenic and tissue-remodeling effects in cultured human retinal pigment epithelial cells. Mol Med Rep. 2021 Nov;24(5):802. doi: 10.3892/mmr.2021.12442. Epub 2021 Sep 15.

    PubMed 34523693
  • Kunikata H, Yasuda M, Aizawa N, Tanaka Y, Abe T, Nakazawa T. Intraocular concentrations of cytokines and chemokines in rhegmatogenous retinal detachment and the effect of intravitreal triamcinolone acetonide. Am J Ophthalmol. 2013 Jun;155(6):1028-1037.e1. doi: 10.1016/j.ajo.2013.01.013. Epub 2013 Mar 12.

    PubMed 23490191
  • Tatar O, Adam A, Shinoda K, Kaiserling E, Boeyden V, Claes C, Eckardt C, Eckert T, Pertile G, Scharioth GB, Yoeruek E, Szurman P, Bartz-Schmidt KU, Grisanti S. Early effects of intravitreal triamcinolone acetonide on inflammation and proliferation in human choroidal neovascularization. Arch Ophthalmol. 2009 Mar;127(3):275-81. doi: 10.1001/archophthalmol.2008.602.

    PubMed 19273790
  • Jonas JB, Hayler JK, Panda-Jonas S. Intravitreal injection of crystalline cortisone as adjunctive treatment of proliferative vitreoretinopathy. Br J Ophthalmol. 2000 Sep;84(9):1064-7. doi: 10.1136/bjo.84.9.1064.

    PubMed 10966969
  • Idrees S, Sridhar J, Kuriyan AE. Proliferative Vitreoretinopathy: A Review. Int Ophthalmol Clin. 2019 Winter;59(1):221-240. doi: 10.1097/IIO.0000000000000258.

    PubMed 30585928
  • Guber J, Bentivoglio M, Valmaggia C, Lang C, Guber I. Predictive Risk Factors for Retinal Redetachment Following Uncomplicated Pars Plana Vitrectomy for Primary Rhegmatogenous Retinal Detachment. J Clin Med. 2020 Dec 14;9(12):4037. doi: 10.3390/jcm9124037.

    PubMed 33327511
  • Machemer R, Aaberg TM, Freeman HM, Irvine AR, Lean JS, Michels RM. An updated classification of retinal detachment with proliferative vitreoretinopathy. Am J Ophthalmol. 1991 Aug 15;112(2):159-65. doi: 10.1016/s0002-9394(14)76695-4.

    PubMed 1867299

Questions about this trial

What is this clinical trial studying?

A study testing Standard Vitrectomy and Triamcinolone acetonide (TA) in people with Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment, run by Anggun Rama Yudantha at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07774182, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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