Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04340505 |
| Other study ID # |
19-700 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 8, 2019 |
| Est. completion date |
March 1, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
The Cleveland Clinic |
| Contact |
Kimberly M Baynes, MSN |
| Phone |
216-444-2566 |
| Email |
baynesk[@]ccf.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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.
Our previous work produced an initial automated algorithm for quantifying anterior chamber
cells, which results a continuous measure of cells per mm3 We have already produced a
desktop-based software interface that allows real time quantification. We have also created
software that would allow clinicians to measure different types of posterior segment
inflammation including retinal vascular leakage on ultra wide field fluorescein angiography
(UWFFA) and vitreous haze with optical coherence tomography (OCT). Our group has demonstrated
the ability of wide field fluorescein angiogram leakage to identify patients who are actively
inflamed and require therapy. Additionally, we have developed an automated leakage analysis
algorithm to quantitate the area of leakage. We will use these tools to measure and
quantitate both anterior segment and posterior segment inflammation in patients receiving the
i-FA implant.
Research Design 1. Perform observational study assessing response of i-FA implant as measured
on ocular imaging.
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. 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.
Image acquisition protocols will depend on subtype of uveitis. In those with anterior
uveitis, only OCT, OCTA and anterior segment OCT will be obtained by study staff. In those
with posterior segment uveitis, UWFFA will be obtained as part of standard of care.
Study Aim:
The purpose is to identify imaging changes in uveitis patients receiving injectable
fluocinolone acetonide implant.
Inclusion Critieria:
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 Critieria:
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.
Protocol:
Baseline visit, standard of care imaging performed including OCT, OCTA, UWFFA. Visual
function measures performed visual acuity contrast sensitivity.
Regular follow-up per clinician standard of care Imaging protocol table
Baseline Week 4-6 Weeks 8-12 Weeks 16-23 Month 6 Visual Function (vision and contrast
sensitivity) x x x x x OCT X X X X X OCTA X X X X X UWFFA (as needed) X X X X X
Statistical analysis
Quantitative Health Service (QHS) have been engaged for statistical analysis and will be
involved in this study.
In brief, correlations between changes in imaging outcomes over time will be analyzed.
All imaging in both studies will be either part of standard of care will be billed to the
patient and/or their insurance. or performed by study staff and not charged to patients.
There will be no financial compensation for the patient as part of this study, but patients
will receive parking vouchers.
Approximately 30 patients will take part in this study.
Adverse Event Reporting
As OCT imaging is a non-contact and non-invasive technique approved by the FDA for routine
clinical imaging there is minimal risk involved for the patient. UWFFA is a FDA approved
device, with a risk of allergy secondary to fluorescein injection through a vein. Allergeric
reactions are rare, but will be reported to the IRB. In the rare case of an adverse event,
the patient will be evaluated by one of the investigators at the Cole Eye Institute and the
IRB will be informed. All adverse events and unanticipated problems will be reviewed and
managed by the principle investigator and treating physician.
Elevated IOP, cataract worsening are known side effects of the injectable FA implant. These
will be monitored during the study.
