Evaluation of EYS606 in Patients With Non-infectious Posterior, Intermediate or Panuveitis

NCT03308045 | Completed Phase 1 DMC

• 1 other identifier: EYS606-CT1
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 4

Brief Summary

Primary objective: safety and tolerability Secondary objectives: additional indicators of long term safety and indicators of clinical activity Exploratory objectives: to characterize EYS606 biodistribution, immunogenicity and biomarkers

Conditions

Non-infectious Uveitis

Keywords

plasmid; electrotransfer; ciliary muscle; uveitis

Outcome Measures

Primary Outcomes (1)

• Number of patients with treatment emergent adverse events

  Assessment of the safety and tolerability of EYS606

  4 weeks

Secondary Outcomes (6)

• Change from baseline in ocular safety assessments

  6 months

• Improvement in best corrected visual acuity

  6 months

• Improvement in anterior chamber cell grade

  6 months

• Improvement in vitreous haze grade

  6 months

• Improvement in central retinal thickness

  6 months

Study Arms (1)

pEYS606

EXPERIMENTAL

Cohort 1 (pEYS606 lower dose); Cohort 2 (pEYS606 intermediate dose); Cohort 3 (pEYS606 higher dose); Extension Cohort (pEYS606 maximum tolerated dose)

Biological: pEYS606

Interventions

pEYS606 BIOLOGICAL

pEYS606 is a DNA plasmid solution administered by electrotransfection into the ciliary muscle

pEYS606

Eligibility Criteria

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

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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 γ-interferon tuberculosis test at the screening 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 TNFα 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.

Sponsors & Collaborators

• Eyevensys: lead

Study Sites (4)

CHU de Grenoble - Hôpital Michallon

Grenoble, 38043, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Bristol Eye Hospital

Bristol, BS1 2LX, United Kingdom

Location

Moorfields Eye Hospital

London, United Kingdom

Location

Related Publications (1)

• Touchard E, Benard R, Bigot K, Laffitte JD, Buggage R, Bordet T, Behar-Cohen F. Non-viral ocular gene therapy, pEYS606, for the treatment of non-infectious uveitis: Preclinical evaluation of the medicinal product. J Control Release. 2018 Sep 10;285:244-251. doi: 10.1016/j.jconrel.2018.07.013. Epub 2018 Aug 1.

  PMID: 30009894 DERIVED

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Officials

• Antoine AB BREZIN, MD

  Hôpital Cochin - Paris - France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Clinical trial with a single arm

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: October 12, 2017
• Study Start: April 4, 2017
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); GB (2)