Imaging of Uveitis Patients Receiving Injectable Fluocinolone Acetonide Implant

NCT04340505 | Completed FDA Drug

• 1 other identifier: 19-700
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

We will prospectively observe patients with uveitis who are either active or were recently active in the previous 6 months and are treated with the i-FA implant. All of the patients will have standard clinical exams at baseline and image quantification of their inflammation using OCT, OCTA and UWFFA (if needed). At baseline, ETDRS vision will be measured. Patients will be followed for 12 months months. During follow-up repeat imaging will be performed along with standard examinations, visual acuity and contrast sensitivity measurements. At the final visit, all tests will be repeated. Data collected will be analyzed using statistical software package. Correlations between changes in imaging quantification of inflammation scores and changes in visual acuity, clinical grades of inflammation, and contract sensitivity will be calculated.

Conditions

Uveitis

Outcome Measures

Primary Outcomes (1)

• To identify imaging changes in uveitis patients receiving injectable fluocinolone acetonide implant.

  Automated imaging markers of inflammation will be analyzed using customized software to assess impact of fluocinolone acetonide implant on imaging.

  one year

Study Arms (1)

Active uveitis patients.

Any patient with a diagnosis of uveitis, who is deemed active or recently active (6 months) by a uveitis specialist and requires an injectable fluocinolone acetonide implant to treat their inflammation.

Drug: Fluocinolone Acetonide

Interventions

Fluocinolone Acetonide DRUG

Injection of fluocinolone acetonide implant will be injected as standard of care treatment for patients with active uveitis.

Active uveitis patients.

Eligibility Criteria

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

Study Population

Patients with active uveitis.

You may qualify if:

• \. Any patient with a diagnosis of uveitis, who is deemed active or recently active (6 months) by a uveitis specialist and requires an injectable fluocinolone acetonide implant to treat their inflammation.

You may not qualify if:

• \- 1. Poor view in fundus in both eyes which precludes image acquisition in those with posterior uveitis 2. Those with any allergy to fluorescein 3. Corneal opacities which prevent image acquisition 4. Inability to sign consent 5. Poor candidates for injectable fluocinolone acetonide (advanced glaucoma without previous filtering surgery, chronic elevated IOP (\>25) on maximal topical anti-glaucoma drops and evidence of optic nerve progression.
• \. Children under the age of 18 and pregnant/nursing mothers.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cole Eye Institute Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Uveitis

Interventions

Fluocinolone Acetonide

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sunil K Srivastava, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 9, 2020
• Study Start: August 8, 2019
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)