Observing the effects of an injectable implant on uveitis patients
Prospective Imaging of the intrAvitreal fluocinoloNe Acetonide Implant Using Fluorescein Angiography and opTical coHerencE tomogRaphy in Uveitis Patients. (PANTHER)
This study is testing how well an injectable implant helps people with uveitis by looking at their vision and inflammation over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04340505 on ClinicalTrials.gov |
What this trial studies
This observational study aims to prospectively monitor patients with uveitis who are either currently active or were recently active within the last six months and are treated with an injectable fluocinolone acetonide implant. Participants will undergo standard clinical exams and imaging quantification of inflammation using OCT, OCTA, and UWFFA as needed. The study will track changes in visual acuity, clinical grades of inflammation, and contrast sensitivity over a 12-month follow-up period, with data analyzed for correlations between imaging results and clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with uveitis who are currently active or have been active in the past six months and require treatment with the injectable implant.
Not a fit: Patients who have poor views of the fundus, allergies to fluorescein, or advanced glaucoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of the injectable fluocinolone acetonide implant in reducing inflammation and improving vision in uveitis patients.
How similar studies have performed: While the injectable fluocinolone acetonide implant has been approved, this specific observational approach to assess its impact on imaging measures of inflammation is novel and has limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. 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. Exclusion Criteria: - 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. 6. Children under the age of 18 and pregnant/nursing mothers.
Where this trial is running
Cleveland, Ohio
- Cole Eye Institute Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Sunil K Srivastava, MD — The Cleveland Clinic
- Study coordinator: Kimberly M Baynes, MSN
- Email: baynesk@ccf.org
- Phone: 216-444-2566
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.