Noninfectious Posterior UveitisFIRENCT07423442
Frequency and Intensity of Inflammatory Relapses in Patients With Non-infectious Posterior Uveitis Treated With a Fluocinolone Acetonide Implant
An observational study of Noninfectious Posterior Uveitis and Uveitis, Posterior, run by Nantes University Hospital at 1 site in France.
Trial summary
Non-infectious posterior uveitis is a chronic inflammatory eye disease that can lead to irreversible retinal damage and visual impairment due to repeated inflammatory relapses. The fluocinolone acetonide intravitreal implant is approved for the prevention of inflammatory relapses in this condition, but data from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noninfectious Posterior Uveitis, Uveitis, Posterior, Uveitic Macular Edema
- What is being tested?
- fluocinolone acetonide intravitreal implant
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients followed in ophthalmology departments of participating French university and general hospitals for non-infectious posterior uveitis or persistent posterior segment inflammation and treated with a fluocinolone acetonide intravitreal implant as part of routine clinical care.
Who may be able to join
- Adult patients aged 18 years or older
- Diagnosis of non-infectious uveitis with posterior segment involvement
- Presence of uveitic macular edema or persistent posterior segment inflammation
- Treatment with a fluocinolone acetonide intravitreal implant prior to January 2024
Who cannot join
- Infectious uveitis
- Refusal to participate or documented opposition to the study
- Follow-up duration shorter than 12 months after implantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Nantes - Ophthalmology Department
Nantes, Nantes, 44000
Alexandra Poinas, PhD, +33 2 40 08 33 33, alexandra.poinas@chu-nantes.fr
About this study
Official title: Frequency and Intensity of REcurrences in Non-infectious Posterior Uveitis Treated With Fluocinolone Acetonide Implant (FACi): a Multicenter Retrospective Real-world Study
Non-infectious posterior uveitis is a chronic inflammatory eye disease that can lead to irreversible retinal damage and visual impairment due to repeated inflammatory relapses.
The fluocinolone acetonide intravitreal implant is approved for the prevention of inflammatory relapses in this condition, but data from real-world clinical practice remain limited, particularly regarding the intensity of relapses over time.
This multicenter retrospective observational study aims to evaluate the frequency and intensity of inflammatory recurrences in adult patients with non-infectious posterior uveitis treated with a fluocinolone acetonide implant. Clinical and imaging data routinely collected during follow-up will be analyzed over a three-year period to better characterize long-term outcomes, treatment burden, and safety in real-life conditions.
Read the detailed description
This is a multicenter, retrospective, real-world observational study conducted in ophthalmology departments of several French university and general hospitals.
The study includes adult patients with non-infectious posterior uveitis or persistent posterior segment inflammation who received a fluocinolone acetonide intravitreal implant as part of routine clinical care. All treatments were prescribed independently of the study, and no intervention was assigned by the investigators.
Data are collected retrospectively from medical records and include clinical, functional, and imaging parameters routinely used in uveitis follow-up. The primary objective is to assess the intensity of inflammatory relapses before and after implantation by analyzing variations in best corrected visual acuity, central macular thickness, and laser flare measurements over predefined time periods.
Secondary objectives include evaluation of relapse frequency, retreatment burden, changes in systemic anti-inflammatory or immunosuppressive therapies, identification of predictive factors associated with relapse severity, and assessment of the long-term safety profile of the fluocinolone acetonide implant in real-life practice.
Data are pseudonymized and recorded in a secure electronic database hosted by the sponsor institution, in compliance with applicable data protection regulations. Analyses are primarily descriptive, reflecting the observational nature of the study.
This study is conducted in accordance with French regulations for non-interventional research and aims to provide complementary real-world evidence to existing clinical trial data on the long-term management of non-infectious posterior uveitis.
- Being tested
- fluocinolone acetonide intravitreal implant
- Medical subject headings
- Uveitis, Posterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluocinolone acetonide intravitreal implantDrug
Intravitreal corticosteroid implant delivering fluocinolone acetonide, administered as part of routine clinical management for the prevention of inflammatory relapses and macular edema in non-infectious posterior uveitis. Treatment decisions were made independently of the study.
| Study group | Role | What they receive |
|---|---|---|
| FACi-treated cohort | Adult patients with non-infectious posterior uveitis or persistent posterior segment inflammation who received a fluocinolone acetonide intravitreal implant as part of routine clinical care. Receives: Drug: fluocinolone acetonide intravitreal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of inflammatory recurrences after fluocinolone acetonide implant
Intensity of inflammatory recurrences assessed as the delta between the highest and lowest values of best corrected visual acuity (ETDRS letters), central macular thickness of the central 1000 µm (µm), and laser flare meter values within predefined time periods before and after implantation.
Measured: Year -1 before implantation 0 to 12 months after implantation 12 to 24 months after implantation 24 to 36 months after implantation
Secondary outcomes (4)
Frequency of inflammatory recurrences and retreatments
Number and timing of local retreatments for uveitic macular edema, including intravitreal dexamethasone implants and subconjunctival triamcinolone injections, before and up to 36 months after fluocinolone acetonide implantation.
Measured: Year -1 before implantation 0 to 36 months after implantation
Change in systemic anti-inflammatory and immunosuppressive treatment burden
Type and dosage of systemic anti-inflammatory and immunosuppressive treatments recorded at baseline and during follow-up after fluocinolone acetonide implantation.
Measured: Baseline (implantation) 12, 24, and 36 months after implantation
Safety outcomes related to intraocular pressure and ocular complications
Occurrence of intraocular pressure elevation and other ocular adverse events, including need for hypotensive treatment, laser trabeculoplasty, surgery, cataract, retinal detachment, endophthalmitis, or intravitreal hemorrhage.
Measured: 0 to 36 months after implantation
Peripapillary retinal nerve fiber layer changes
Changes in peripapillary retinal nerve fiber layer thickness measured by optical coherence tomography in predefined sectors.
Measured: Baseline 12, 24, and 36 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study startJun 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noninfectious Posterior UveitisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423442
- Sponsor's protocol ID
- AP_JBD_SG_fire
- Acronym
- FIRE
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Intensity of REcurrences in Non-infectious Posterior Uveitis Treated With Fluocinolone Acetonide Implant (FACi): a Multicenter Retrospective Real-world Study
- ClinicalTrials.gov ID
- NCT07423442
- Acronym / sponsor ID
- FIRE / AP_JBD_SG_fire
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 20 Feb 2026 (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.
Non-infectious posterior uveitis is a chronic inflammatory eye disease that can lead to irreversible retinal damage and visual impairment due to repeated inflammatory relapses.
The fluocinolone acetonide intravitreal implant is approved for the prevention of inflammatory relapses in this condition, but data from real-world clinical practice remain limited, particularly regarding the intensity of relapses over time.
This multicenter retrospective observational study aims to evaluate the frequency and intensity of inflammatory recurrences in adult patients with non-infectious posterior uveitis treated with a fluocinolone acetonide implant. Clinical and imaging data routinely collected during follow-up will be analyzed over a three-year period to better characterize long-term outcomes, treatment burden, and safety in real-life conditions.
Detailed description
This is a multicenter, retrospective, real-world observational study conducted in ophthalmology departments of several French university and general hospitals.
The study includes adult patients with non-infectious posterior uveitis or persistent posterior segment inflammation who received a fluocinolone acetonide intravitreal implant as part of routine clinical care. All treatments were prescribed independently of the study, and no intervention was assigned by the investigators.
Data are collected retrospectively from medical records and include clinical, functional, and imaging parameters routinely used in uveitis follow-up. The primary objective is to assess the intensity of inflammatory relapses before and after implantation by analyzing variations in best corrected visual acuity, central macular thickness, and laser flare measurements over predefined time periods.
Secondary objectives include evaluation of relapse frequency, retreatment burden, changes in systemic anti-inflammatory or immunosuppressive therapies, identification of predictive factors associated with relapse severity, and assessment of the long-term safety profile of the fluocinolone acetonide implant in real-life practice.
Data are pseudonymized and recorded in a secure electronic database hosted by the sponsor institution, in compliance with applicable data protection regulations. Analyses are primarily descriptive, reflecting the observational nature of the study.
This study is conducted in accordance with French regulations for non-interventional research and aims to provide complementary real-world evidence to existing clinical trial data on the long-term management of non-infectious posterior uveitis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FACi-treated cohort | – | Drug: fluocinolone acetonide intravitreal implantAdult patients with non-infectious posterior uveitis or persistent posterior segment inflammation who received a fluocinolone acetonide intravitreal implant as part of routine clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients followed in ophthalmology departments of participating French university and general hospitals for non-infectious posterior uveitis or persistent posterior segment inflammation and treated with a fluocinolone acetonide intravitreal implant as part of routine clinical care.
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or older
- Diagnosis of non-infectious uveitis with posterior segment involvement
- Presence of uveitic macular edema or persistent posterior segment inflammation
- Treatment with a fluocinolone acetonide intravitreal implant prior to January 2024
Key exclusion criteria (3 listed)
- Infectious uveitis
- Refusal to participate or documented opposition to the study
- Follow-up duration shorter than 12 months after implantation
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 |
|---|---|---|
| fluocinolone acetonide intravitreal implantIntravitreal corticosteroid implant delivering fluocinolone acetonide, administered as part of routine clinical management for the prevention of inflammatory relapses and macular edema in non-infectious posterior uveitis. Treatment decisions were made independently of the study. | Drug | FACi-treated cohort |
Primary outcome
Intensity of inflammatory recurrences after fluocinolone acetonide implant
Time frame: Year -1 before implantation 0 to 12 months after implantation 12 to 24 months after implantation 24 to 36 months after implantation
Intensity of inflammatory recurrences assessed as the delta between the highest and lowest values of best corrected visual acuity (ETDRS letters), central macular thickness of the central 1000 µm (µm), and laser flare meter values within predefined time periods before and after implantation.
4 secondary outcomes
Frequency of inflammatory recurrences and retreatments
Time frame: Year -1 before implantation 0 to 36 months after implantation
Change in systemic anti-inflammatory and immunosuppressive treatment burden
Time frame: Baseline (implantation) 12, 24, and 36 months after implantation
Safety outcomes related to intraocular pressure and ocular complications
Time frame: 0 to 36 months after implantation
Peripapillary retinal nerve fiber layer changes
Time frame: Baseline 12, 24, and 36 months after implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Noninfectious Posterior Uveitis and Uveitis, Posterior, run by Nantes University Hospital at 1 site 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Jun 2026. 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 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean Baptiste DUCLOYER, MD, PhD (02 40 08 34 01, jeanbaptiste.ducloyer@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of inflammatory recurrences after fluocinolone acetonide implant (time frame: Year -1 before implantation 0 to 12 months after implantation 12 to 24 months after implantation 24 to 36 months after implantation). 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 24 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.