| Eligibility |
Inclusion Criteria:
- Patient must be 18 years of age or older
- Both female patients of childbearing potential and male patients able to father a
child must agree to practice at least one effective method of birth control for six
months following administration of study medication. Acceptable methods of birth
control for this study include hormonal contraception (birth control pills, injected
hormones, dermal patch or vaginal ring), intrauterine device, barrier methods
(diaphragm, condom) with spermicide or surgical sterilization (hysterectomy, tubal
ligation or vasectomy). Patients with a hysterectomy or vasectomy (or have a partner
with a hysterectomy or vasectomy) are exempt from using these methods of birth
control.
- Female patients of childbearing potential must not be pregnant or breast-feeding and
must have a negative urine pregnancy test at baseline and throughout the study.
- Voluntary written informed consent before performance of any study related procedure
not part of normal medical care, with the understanding that consent may be withdrawn
by the subject at any time without prejudice to future medical care.
- Patient has only one eligible eye with the following criteria:
- non-infectious intermediate, posterior, or panuveitis,
- media clarity, pupillary dilation, and individual cooperation sufficient for adequate
fundus imaging,
- macular atrophy, AND/OR degenerative macular edema, AND/OR advanced optic neuropathy,
AND/OR macular scar,
- Patients must maintain regiment of local and/or systemic corticosteroids between
screening and baseline (if applicable).
Visual Criteria - Part 1 (enrolment is Part 1 is completed)
- BCVA of 0.1 (ETDRS of 35) or worse at screening in the treated eye, and BCVA of 0.32 or
higher in the fellow eye.
Key Inclusion Criteria - Part 2 (enrolment in Part 2 is ongoing)
- BCVA of = 0.63 or 20/32 Snellen but = 0.025 or 20/800 Snellen (equivalent to = 5 and =
77 ETDRS letters) in the treated eye
- Patient must have a diagnosis of non-infectious uveitis of any anatomic subtype
- Patient must have a history of chronic or recurrent uveitis requiring or having
required treatment with corticosteroids (systemic, periocular or intraocular) and/or
systemic immunosuppressive medication(s) in the 12 months prior to the screening visit
- At the screening and baseline visits patient must have active uveitis as evidenced by
at least one or more of the following in the study eye:
oActive retinal vasculitis (retinal vascular leakage) oVitreous haze grade = 2+ oAnterior
chamber cell grade = 2+ oMacular edema
- Patient receiving concomitant topical and/or systemic corticosteroids or allowed
systemic immunosuppressive medications must have maintained the same treatment regimen
(dosage/frequency) for at least 2 weeks prior to the baseline (V1) visit, (if
applicable).
- Willingness to receive local therapy to treat ocular inflammation in the fellow eye
during the course of the study (if needed).
Exclusion Criteria:
- Patient has or is suspected to have infectious uveitis or a uveitis masquerade
syndrome.
- Patient suspected to have tuberculosis, has had a positive test for tuberculosis in
the past or has a positive ?-interferon tuberculosis test at the screening visit.
- For a patient with a primary diagnosis of idiopathic intermediate uveitis exclusion of
any signs of multiple sclerosis must be demonstrated by an MRI examination of the
brain and orbits with gadolinium prior to the baseline visit.
- Patient with macular edema as the only evidence of uveitis (e.g. absence of any
vitreous haze or vasculitis) for which a non-uveitic cause of macular edema such as
cataract extraction, age-related macular degeneration, diabetic retinopathy or retinal
vein occlusion cannot be excluded.
- Patient with media opacity in the study eye that precludes visualization of the fundus
or that is likely to require cataract surgery during the course of the trial.
- Patient with history of glaucoma filtering surgery (e.g. trabeculectomy or aqueous
shunt implant) or who underwent eye surgery within 3 months in the treated eye.
- Patient who has uncontrolled intraocular pressure of = 25 mmHg in the study eye at the
screening and baseline visits.
- Patient with intraocular hypotension (<6 mmHg) that in the opinion of the Investigator
would interfere with the administration of EYS606 or the evaluation of its safety or
efficacy.
- Patient with history of scleritis, scleral thinning, cicatrizing conjunctival
diseases, severe ocular allergies or other severe ocular surface disease that could
interfere with the administration of EYS606 or the evaluation of its safety or
efficacy.
- Patient has received Ozurdex® (dexamethasone implant) or other intraocular or
periocular corticosteroids injections within 3 months prior to the baseline visit in
the study eye
- Patient has received a fluocinolone implant (Retisert®, Illuvien®, YutiqTM) within 12
months prior to the baseline visit in the study eye.
- Patient has received treatment with a TNFa inhibitor intravitreally in the study eye
within 2 months prior to the baseline visit.
- Patient has received intravitreal anti-VEGF therapy such as Lucentis® (ranibizumab) or
Avastin® (bevacizumab) or Eylea® (aflibercept) within 2 months prior to the baseline
visit or Beovu® (Brolucizumab) within 3 months prior to the baseline visit in the
study eye.
- Patient has received intravitreal methotrexate within 2 months prior to the baseline
visit in the study eye.
- Patient with a history of allergic reaction or intolerance to any routinely used
ophthalmic medicines (e.g. fluorescein dye, topical dilating agents or local
anesthetics) that will be prescribed during the course of the study.
- Patient with active or uncontrolled underlying systemic autoimmune or inflammatory
disease requiring or likely to require an increase in systemic immunosuppressive
medications or treatment with a biologic agent during the course of the study.
- Patient has received treatment with an alkylating agent (cyclophosphamide or
chlorambucil) for the management of uveitis or an associated underlying disease.
- Patient has received treatment with a systemic biologic therapy (e.g. anti-TNFa,
anti-IL-1, anti-IL-6, anti-IL-17, interferon) within 1 month prior to the baseline
visit.
- Patient has received treatment with Rituximab within 6 months of the baseline visit.
- Patient with a history of or current evidence of any unstable medical condition (such
as heart disease due to a cardiac conduction abnormality requiring a pacemaker,
neurologic or psychiatric disorders requiring electroconvulsive therapy, acute or
chronic liver diseases, malignancy, severe systemic allergy, etc.) that in the opinion
of the Investigator, would expose the subject to an undue risk of a significant
adverse event or interfere with the administration of EYS606 or the evaluation of its
safety or efficacy during the course of the trial.
|
