Triamcinolone acetonide to prevent PVR in eyes undergoing vitreoretinal surgery for open globe trauma - AOT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005138-35-GB

Enrollment

Registered

2008-01-25

Start date

2008-06-06

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proliferative vitreoretinopathy following open globe trauma. MedDRA version: 9.1 Level: LLT Classification code 10057896 Term:

Interventions

Trade Name: Kenalog Product Name: Kenalog Product Code: A01AC10 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Triam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: An open globe injury requiring vitrectomy either following a primary globe repair or as the primary procedure itself. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Glaucoma, ocular hypertension or steroid responsive glaucoma. 2) Previous vitrectomy. 3) Enrolment in other studies. 4) Inability to attend regular follow up. 5) Unable to give informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: This is a pilot RCT to investigate the the effect of the use of peroperative intravitreal triamcinilone acetate in the development of proliferative vitreoretinopathy following open globe trauma.;Secondary Objective: ;Primary end point(s): The trial will end when all 40 patients have been reviewed 6 months following the peroperative treatment with triamcinolone. The trial will be terminated earlier if there is evidence that this treatment protocol is clearly inferior to the standard treatment.	—

Measure

Time frame

Main Objective: This is a pilot RCT to investigate the the effect of the use of peroperative intravitreal triamcinilone acetate in the development of proliferative vitreoretinopathy following open globe trauma.;Secondary Objective: ;Primary end point(s): The trial will end when all 40 patients have been reviewed 6 months following the peroperative treatment with triamcinolone. The trial will be terminated earlier if there is evidence that this treatment protocol is clearly inferior to the standard treatment.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026