Eye Injury TraumaPhase 3ASCOTNCT02873026
Adjunctive Steroid Combination in Ocular Trauma (ASCOT) Study
A Phase 3 study testing Triamcinolone Acetonide in people with Eye Injury Trauma, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Injury Trauma
- What is being tested?
- Triamcinolone Acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to 31 Jan 2021
- Phase
- Phase 3
- 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
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3 Multi-centre Double-masked Randomised Controlled Trial of Adjunctive Intraocular and Periocular Steroid (Triamcinolone Acetonide) Versus Standard Treatment in Eyes Undergoing Vitreoretinal Surgery for Open Globe Trauma.
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.
Read the detailed description
Trauma is an important cause of visual impairment and blindness worldwide and a leading cause of blindness in young adult males.Globally it has been estimated that 1.6 million people are blind as a result of ocular trauma with 2.3 million suffering bilateral low vision. Ocular trauma is the commonest cause of unilateral blindness in the world today with up to 19 million with unilateral blindness or low vision. It is estimated that almost one million people in the United States live with trauma-related visual impairment. Ocular trauma has extensive socio-economic costs - patients with open globe injuries lose a mean of 70 days of work. In the United States work related eye injuries cost over $300 million per year (www.prevent blindness.org) this equates to an annual cost to the UK economy (for which no comparable data exists) of £37.5 million.
In the UK it is estimated that 5000 patients per year sustain eye injuries serious enough to require hospital admission and of these 250 will be permanently blinded in the injured eye. Recent European studies document incidences of 2.4 and 3.2 per 100000 per year for open-globe injuries which suggests an annual incidence for the UK of between 1500 and 2000.
Ocular injuries which result in visual loss invariably affect the posterior segment of the eye and prevention of visual loss involves posterior segment (vitreoretinal) surgery. It is clear from recent published data that although vitreoretinal surgical techniques have improved, outcomes remain unsatisfactory and that development of the intraocular scarring response proliferative vitreoretinopathy (PVR) is the leading cause of this.
- Conditions
- Eye Injury Trauma
- Being tested
- Triamcinolone Acetonide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Also called kenalog
Following the repair of the open globe eye trauma, the use of Triamcinolone Acetonide will be investigated
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
Total visual acuity score at 6 months
Total EDTRS score in the study eye at the 6 months follow up appointment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startOct 2014
- Primary completion31 Mar 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eye Injury TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Charteris, MD, Principal investigator, Moorfields Eye Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873026
- Sponsor's protocol ID
- CHAD1031
- Acronym
- ASCOT
- Status last verified
- Sep 2021
- First submitted
- 13 Jun 2016
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 39680515Casswell 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.
PubMed 36849205
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multi-centre Double-masked Randomised Controlled Trial of Adjunctive Intraocular and Periocular Steroid (Triamcinolone Acetonide) Versus Standard Treatment in Eyes Undergoing Vitreoretinal Surgery for Open Globe Trauma.
- ClinicalTrials.gov ID
- NCT02873026
- Acronym / sponsor ID
- ASCOT / CHAD1031
- Conditions
- Eye Injury Trauma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Trauma is an important cause of visual impairment and blindness worldwide and a leading cause of blindness in young adult males.Globally it has been estimated that 1.6 million people are blind as a result of ocular trauma with 2.3 million suffering bilateral low vision. Ocular trauma is the commonest cause of unilateral blindness in the world today with up to 19 million with unilateral blindness or low vision. It is estimated that almost one million people in the United States live with trauma-related visual impairment. Ocular trauma has extensive socio-economic costs - patients with open globe injuries lose a mean of 70 days of work. In the United States work related eye injuries cost over $300 million per year (www.prevent blindness.org) this equates to an annual cost to the UK economy (for which no comparable data exists) of £37.5 million.
In the UK it is estimated that 5000 patients per year sustain eye injuries serious enough to require hospital admission and of these 250 will be permanently blinded in the injured eye. Recent European studies document incidences of 2.4 and 3.2 per 100000 per year for open-globe injuries which suggests an annual incidence for the UK of between 1500 and 2000.
Ocular injuries which result in visual loss invariably affect the posterior segment of the eye and prevention of visual loss involves posterior segment (vitreoretinal) surgery. It is clear from recent published data that although vitreoretinal surgical techniques have improved, outcomes remain unsatisfactory and that development of the intraocular scarring response proliferative vitreoretinopathy (PVR) is the leading cause of this.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Triamcinolone AcetonideTriamcinolone 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone AcetonideAlso: kenalogFollowing the repair of the open globe eye trauma, the use of Triamcinolone Acetonide will be investigated | Drug | Triamcinolone acetonide |
Primary outcome
Improvement of visual acuity at 6 months
Time frame: 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)
1 secondary outcome
Total visual acuity score at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Derived from this study: PubMed 39680515Ezeofor 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.
- Derived from this study: PubMed 36849205Casswell 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Charteris, MD principal investigator
Moorfields Eye Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triamcinolone Acetonide in people with Eye Injury Trauma, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 8 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 17 Sep 2021. 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 United Kingdom. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement of visual acuity at 6 months (time frame: 6 months). 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 NCT02873026, which also lists 2 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 17 Sep 2021.