Prospective Imaging of the intrAvitreal fluocinoloNe Acetonide Implant Using Fluorescein Angiography and opTical coHerencE tomogRaphy in Uveitis Patients. (PANTHER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To identify imaging changes in uveitis patients receiving injectable fluocinolone acetonide implant.
研究概览
简要总结
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.
详细描述
Prospective imaging of the intrAvitreal fluocinoloNe acetonide implant using fluorescein angiography and opTical coHerencE tomogRaphy in uveitis patients. (PANTHER)
Background Uveitis, a disease with high visual morbidity Uveitis accounts for up to 20% of legal blindness in the developed world.It is characterized by invasion of inflammatory cells into the eye with resultant permanent damage of normal ocular tissue without treatment. Complications of uveitis include cataracts, glaucoma, macular edema and retinal degeneration.
Until recently treatment regimens for chronic uveitis include systemic immune suppressive agents and a surgically placed steroid implant (fluocinolone acetonide). Both treatment regimens have shown the ability to reduce complication risks and improve vision (MUST study results). The benefits of each regimen, however are mitigated by their potential side effects. The surgically placed implant has high risk of glaucoma and cataract.
This year, a long term injectable fluocinolone acetonide (i-FA) implant was approved for use in chronic uveitis patients (Yutiq, Eyepoint Pharmaceuticals). As opposed to the surgically placed implant, this implant is placed in the office and has lower reported rates of glaucoma and cataract.
Although approved for use, little data exists of the impact of the i-FA implant on imaging measures of inflammation including OCT and fluorescein angiography. Since these imaging devices are often used to monitor patient's response, a prospective evaluation of the impact of the iFA implant on these measures is needed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Poor view in fundus in both eyes which precludes image acquisition in those with posterior uveitis
- •Those with any allergy to fluorescein
- •Corneal opacities which prevent image acquisition
- •Inability to sign consent
- •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.
研究组 & 干预措施
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.
干预措施: Fluocinolone Acetonide (Drug)
结局指标
主要结局
To identify imaging changes in uveitis patients receiving injectable fluocinolone acetonide implant.
时间窗: one year
Automated imaging markers of inflammation will be analyzed using customized software to assess impact of fluocinolone acetonide implant on imaging.
次要结局
未报告次要终点
研究者
Sunil Srivastava
Staff Physician
The Cleveland Clinic