Adjunctive Steroid Combination in Ocular Trauma (ASCOT) Study

NCT02873026 | Completed Phase 3 DMC

• 1 other identifier: CHAD1031
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Eye trauma is a leading cause of blindness and visual impairment. Penetrating injuries of the eye are more likely to result in poor vision and the main cause of this is a scarring response on the retina (proliferative vitreoretinopathy, PVR) The purpose of this study is to investigate the potential of an anti-inflammatory treatment (triamcinolone acetonide) to improve the outcome of surgery in eyes that have suffered severe trauma.There is good evidence from laboratory studies that additional steroid treatment into and around the eye at the time of surgery could reduce scarring by reducing inflammation and improve visual outcomes.

Conditions

Eye Injury Trauma

Outcome Measures

Primary Outcomes (1)

• Improvement of visual acuity at 6 months

  The proportion of patients with an improvement from baseline to 6 months of at least 10 on the corrected visual acuity in the study eye (total ETDRS letter score measured at 4 metres and 1 metre)

  6 months

Secondary Outcomes (1)

• Total visual acuity score at 6 months

  6 months

Study Arms (2)

Standard care

NO INTERVENTION

The patient will receive the standard care given to all patients that have received a vitrectomy following open globe trauma.

Triamcinolone acetonide

EXPERIMENTAL

Triamcinolone Acetonide 4mg/0.1ml intravitreal cavity and 40mg/1ml subtenons to be injected at the time of the vitrectomy. Patients will then receive standard care following operation.

Drug: Triamcinolone Acetonide

Interventions

Triamcinolone Acetonide DRUG

Following the repair of the open globe eye trauma, the use of Triamcinolone Acetonide will be investigated

Also known as: kenalog

Triamcinolone acetonide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects (Aged 18 years or over at the time of enrolment)
• Full thickness, open-globe ocular trauma undergoing vitrectomy
• Ability to give written informed consent
• Willingness to accept randomization and attend follow-up for 6 months.

You may not qualify if:

• Children (Age less than 18 years old at time of enrollment)
• Pre-existing uncontrolled uveitis - Patients with pre-existing uveitis are likely to be rare in the study population however they have a pre-disposition to a more aggressive form of proliferative vitreoretinopathy and will therefore be excluded. (This does not include patients whose uveitis is secondary to their injury or retinal detachment)
• Definitive diagnosis of previous steroid induced glaucoma - these patients are at risk of steroid related pressure rise and will be excluded (this does not include patients in whom a query of previous steroid-induced raised IOP has been postulated)
• Pregnant or Breastfeeding females (Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; true abstinence) from the time consent is signed until 6 weeks after their completion of the trial. Females of childbearing potential must have a negative urinary pregnancy test within 7 days prior to being registered for trial treatment (Subjects are considered not of child bearing potential if they are permanently sterile (i.e. they have undergone a hysterectomy, bilateral tubal occlusion, or bilateral salpingectomy) or they are postmenopausal)
• Allergy or previous known adverse reaction to triamcinolone acetonide
• Inability to attend regular follow up
• Unable to give written informed consent
• Current or planned systemic corticosteroid use of a dose above physiological levels (e.g. \>10mg prednisolone)

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

Study Sites (1)

Moorfields Eye Hospital

London, United Kingdom

Location

Related Publications (2)

• Ezeofor V', Anthony BF, Bryning L, Casswell EJ, Cro S, Cornelius VR, Bunce C, Robertson E, Kelly J, Murphy C, Banerjee PJ, Charteris DG, Edwards RT. Economic evaluation of an adjunctive intraocular and peri-ocular steroid vitreoretinal surgery for open globe trauma: Cost-effectiveness of the ASCOT randomised controlled trial. PLoS One. 2024 Dec 16;19(12):e0311158. doi: 10.1371/journal.pone.0311158. eCollection 2024.

  PMID: 39680515 DERIVED

• Casswell EJ, Cro S, Cornelius VR, Banerjee PJ, Zvobgo TM, Tudor Edwards R, Ezeofor V, Anthony B, Shahid SM, Bunce C, Kelly J, Murphy C, Robertson E, Charteris D; ASCOT Investigator Study Group. Randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery following open globe trauma: The ASCOT study. Br J Ophthalmol. 2024 Feb 21;108(3):440-448. doi: 10.1136/bjo-2022-322787.

  PMID: 36849205 DERIVED

MeSH Terms

Interventions

Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• David Charteris, MD

  Moorfields Eye Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: August 19, 2016
• Study Start: October 1, 2014
• Primary Completion: March 31, 2020
• Study Completion: January 31, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

GB (1)