Post-operative EndophthalmitisPhase 3EndophtalmitisNCT01768078
Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis
A Phase 3 study testing Intravitreal injection of Betamethasone + antibiotics and Intravitreal injection of antibiotics in people with Post-operative Endophthalmitis, run by Centre Hospitalier Universitaire Dijon at 6 sites in France.
Trial summary
One useful effect of early intravitreal corticotherapy is to diminish inflammatory complications after endophthalmitis, which may cause, at least in part, serious complications (retinal detachment, macular edema) which are, more than the infection, causes of the complications seen after acute endophthalmitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-operative Endophthalmitis
- What is being tested?
- Intravitreal injection of Betamethasone + antibiotics and Intravitreal injection of antibiotics
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 6 sitesFrance
- Study dates
- Sep 2008to Oct 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients male or female with no age limit
- Hospitalized for the diagnosis and treatment of acute endophthalmitis following cataract surgery
- Who had given their consent after being informed about intravitreal corticotherapy
Who cannot join
- Patients who refused or were unable to give their consent
- Prior intravitreal corticotherapy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU de Besançon
Besançon, 25000
CHU
Dijon, 21000
CHU de Grenoble
Grenoble
CHU de Nancy
Nancy, 54000
CHU de Saint Etienne
Saint-Etienne
CHU de Strasbourg
Strasbourg, 67091
About this study
Official title: Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis.
One useful effect of early intravitreal corticotherapy is to diminish inflammatory complications after endophthalmitis, which may cause, at least in part, serious complications (retinal detachment, macular edema) which are, more than the infection, causes of the complications seen after acute endophthalmitis.
- Conditions
- Post-operative Endophthalmitis
- Being tested
- Intravitreal injection of Betamethasone + antibiotics, Intravitreal injection of antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection of Betamethasone + antibioticsProcedure or surgery
Intravitreal injection of antibioticsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| with corticoids | Experimental | Not described Receives: Procedure: Intravitreal injection of Betamethasone + antibiotics |
| without corticoids | Other | Not described Receives: Procedure: Intravitreal injection of antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the evolution of visual acuity
Measured: up to12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startSep 2008
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative EndophthalmitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768078
- Sponsor's protocol ID
- Creuzot-Garcher PHRC IR 2007
- Acronym
- Endophtalmitis
- Status last verified
- Dec 2018
- First submitted
- 8 Jan 2013
- Last updated
- 27 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis.
- ClinicalTrials.gov ID
- NCT01768078
- Acronym / sponsor ID
- Endophtalmitis / Creuzot-Garcher PHRC IR 2007
- Conditions
- Post-operative Endophthalmitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Sep 2008 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 Jan 2013 (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.
One useful effect of early intravitreal corticotherapy is to diminish inflammatory complications after endophthalmitis, which may cause, at least in part, serious complications (retinal detachment, macular edema) which are, more than the infection, causes of the complications seen after acute endophthalmitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with corticoids | Experimental | Procedure: Intravitreal injection of Betamethasone + antibiotics |
| without corticoids | Other | Procedure: Intravitreal injection of antibiotics |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All patients male or female with no age limit
- Hospitalized for the diagnosis and treatment of acute endophthalmitis following cataract surgery
- Who had given their consent after being informed about intravitreal corticotherapy
Key exclusion criteria (2 listed)
- Patients who refused or were unable to give their consent
- Prior intravitreal corticotherapy
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 |
|---|---|---|
| Intravitreal injection of Betamethasone + antibiotics | Procedure or surgery | with corticoids |
| Intravitreal injection of antibiotics | Procedure or surgery | without corticoids |
Primary outcome
Measure the evolution of visual acuity
Time frame: up to12 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 27 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravitreal injection of Betamethasone + antibiotics and Intravitreal injection of antibiotics in people with Post-operative Endophthalmitis, run by Centre Hospitalier Universitaire Dijon at 6 sites in France.
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 3 inclusion and 2 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 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
Measure the evolution of visual acuity (time frame: up to12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2018.