Frequency and Intensity of Inflammatory Relapses in Patients With Non-infectious Posterior Uveitis Treated With a Fluocinolone Acetonide Implant

NCT07423442 | Not Yet Recruiting

• 1 other identifier: AP_JBD_SG_fire
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Noninfectious Posterior Uveitis; Uveitis, Posterior; Uveitic Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Year -1 before implantation 0 to 36 months after implantation

• Change in systemic anti-inflammatory and immunosuppressive treatment burden

  Baseline (implantation) 12, 24, and 36 months after implantation

• Safety outcomes related to intraocular pressure and ocular complications

  0 to 36 months after implantation

• Peripapillary retinal nerve fiber layer changes

  Baseline 12, 24, and 36 months after implantation

Study Arms (1)

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.

Drug: fluocinolone acetonide intravitreal implant

Interventions

fluocinolone acetonide intravitreal implant DRUG

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.

FACi-treated cohort

Eligibility Criteria

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

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.

You may qualify if:

• 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

You may not qualify if:

• Infectious uveitis
• Refusal to participate or documented opposition to the study
• Follow-up duration shorter than 12 months after implantation

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Conditions

Uveitis, Posterior

Interventions

Fluocinolone Acetonide

Condition Hierarchy (Ancestors)

Panuveitis; Uveitis; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Jean Baptiste DUCLOYER, MD, PhD

CONTACT

02 40 08 34 01; jeanbaptiste.ducloyer@chu-nantes.fr

Alexandra Poinas, PhD

CONTACT

+33 2 53 48 28 57; alexandra.poinas@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02