Intravitreal InjectionENIVACNCT03635268
Endophthalmitis After Intravitreal Injection of Antiangiogenic Agents or Corticosteroids, a Cohort Study of the French Population of Patients Who Received Injections Over 9 Years
An observational study of Intravitreal Injection, run by Centre Hospitalier Universitaire Dijon.
Trial summary
Intravitreal injections (IVI) of antiangiogenic agents (AA) have revolutionized the management of age-related macular degeneration (AMD) and diabetic macular edema (DME) in particular. Approximately 600,000 AA IVIs are performed each year in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravitreal Injection
- What is being tested?
- Data collection
- How many people
- 360,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Aug 2017
- Phase
- Observational
- 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
Study population: Patient who has had an intravitreal injection to deliver an anti-angiogenic agent or a corticosteroid
Who may be able to join
- adult patients within the French population who had an intravitreal injection, identified by CCAM coding BGLB001
- associated with the delivery of an anti-angiogenic agent or a corticosteroid, identified by the corresponding CIP code
- between February 2007 and November 2015
Who cannot join
- intraocular surgery less than 42 days before the first injection, identified by the CCAM procedure
- risk factors for endogenous endophthalmitis identified in the 42 days preceding an IVI identified by the ICD10 code
About this study
Intravitreal injections (IVI) of antiangiogenic agents (AA) have revolutionized the management of age-related macular degeneration (AMD) and diabetic macular edema (DME) in particular. Approximately 600,000 AA IVIs are performed each year in France.
Corticosteroid IVIs are an alternative in the treatment of macular edema when it is diabetic or related to venous occlusion, but also due to inflammation.
Read more
Endophthalmitis is one of the most feared complications after IVI because of its poor prognosis, despite its low incidence (values found in the literature between 0.01% and 0.08%). IVI practices have evolved over the years based on the recommendations of specialized organizations, with the current recommendation not to use antibiotic prophylaxis.
The purpose of this study is to study the effect of intravitreal injections of anti-angiogenic agents and corticosteroids on the occurrence of endophthalmitis within 28 days following an injection.
- Conditions
- Intravitreal Injection
- Being tested
- Data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Sociodemographic, medical and hospital, on ambulatory care consumption data.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of occurrence of endophthalmitis
Measured: Up to 28 days following an intravitreal injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Jan 2016
- Primary completion1 Dec 2016
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intravitreal InjectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 360,000 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
- NCT03635268
- Sponsor's protocol ID
- MARIET AOI 2017
- Acronym
- ENIVAC
- Status last verified
- Feb 2026
- First submitted
- 14 Aug 2018
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baudin F, Benzenine E, Mariet AS, Bron AM, Daien V, Korobelnik JF, Quantin C, Creuzot-Garcher C. Association of Acute Endophthalmitis With Intravitreal Injections of Corticosteroids or Anti-Vascular Growth Factor Agents in a Nationwide Study in France. JAMA Ophthalmol. 2018 Dec 1;136(12):1352-1358. doi: 10.1001/jamaophthalmol.2018.3939.
PubMed 30242325
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endophthalmitis After Intravitreal Injection of Antiangiogenic Agents or Corticosteroids, a Cohort Study of the French Population of Patients Who Received Injections Over 9 Years
- ClinicalTrials.gov ID
- NCT03635268
- Acronym / sponsor ID
- ENIVAC / MARIET AOI 2017
- Conditions
- Intravitreal Injection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360,000 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 17 Aug 2018 (actual)
- 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.
Intravitreal injections (IVI) of antiangiogenic agents (AA) have revolutionized the management of age-related macular degeneration (AMD) and diabetic macular edema (DME) in particular. Approximately 600,000 AA IVIs are performed each year in France.
Corticosteroid IVIs are an alternative in the treatment of macular edema when it is diabetic or related to venous occlusion, but also due to inflammation.
Endophthalmitis is one of the most feared complications after IVI because of its poor prognosis, despite its low incidence (values found in the literature between 0.01% and 0.08%). IVI practices have evolved over the years based on the recommendations of specialized organizations, with the current recommendation not to use antibiotic prophylaxis.
The purpose of this study is to study the effect of intravitreal injections of anti-angiogenic agents and corticosteroids on the occurrence of endophthalmitis within 28 days following an injection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who has had an intravitreal injection to deliver an anti-angiogenic agent or a corticosteroid
Key inclusion criteria (3 listed)
- adult patients within the French population who had an intravitreal injection, identified by CCAM coding BGLB001
- associated with the delivery of an anti-angiogenic agent or a corticosteroid, identified by the corresponding CIP code
- between February 2007 and November 2015
Key exclusion criteria (2 listed)
- intraocular surgery less than 42 days before the first injection, identified by the CCAM procedure
- risk factors for endogenous endophthalmitis identified in the 42 days preceding an IVI identified by the ICD10 code
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 |
|---|---|---|
| Data collectionSociodemographic, medical and hospital, on ambulatory care consumption data. | Other | – |
Primary outcome
Frequency of occurrence of endophthalmitis
Time frame: Up to 28 days following an intravitreal injection
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 9 Feb 2026.
- Results publication: PubMed 30242325Baudin F, Benzenine E, Mariet AS, Bron AM, Daien V, Korobelnik JF, Quantin C, Creuzot-Garcher C. Association of Acute Endophthalmitis With Intravitreal Injections of Corticosteroids or Anti-Vascular Growth Factor Agents in a Nationwide Study in France. JAMA Ophthalmol. 2018 Dec 1;136(12):1352-1358. doi: 10.1001/jamaophthalmol.2018.3939.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Intravitreal Injection, run by Centre Hospitalier Universitaire Dijon.
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 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Frequency of occurrence of endophthalmitis (time frame: Up to 28 days following an intravitreal injection). 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 NCT03635268, which also lists 1 linked publication.
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 9 Feb 2026.