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Non-infectious UveitisPhase 1/2NCT03308045

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

A Phase 1/2 study testing pEYS606 in people with Non-infectious Uveitis, run by Eyevensys at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-infectious Uveitis
What is being tested?
pEYS606
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
4 sitesin 2 countries
Study dates
4 Apr 2017to 1 Jun 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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,
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  • 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).

Who cannot join

  • 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.
  • 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.
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  • 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.
  • 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-TNFα, 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.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

France2 sites

  • CHU de Grenoble - Hôpital Michallon

    Grenoble, 38043

  • Hôpital Cochin

    Paris, 75014

Other trials in France

United Kingdom2 sites

  • Bristol Eye Hospital

    Bristol, BS1 2LX

  • Moorfields Eye Hospital

    London

Other trials in United Kingdom

About this study

Official title: A Phase I/II, Open-label, Multicentre, Dose Escalation Study Assessing Safety/Tolerability of pEYS606 When Administered by Electrotransfer (ET) in Ciliary Muscle of Patients With Non-infectious Posterior, Intermediate or Panuveitis

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

Read the detailed description

The maximum study duration per patient is 51 Weeks (including an up to 3 week screening period + 48 weeks follow-up after treatment).

The study is conducted in 2 parts. Part 1 is a dose escalation phase which will investigate three pEYS606 doses levels (lower, intermediate and higher dose) over 3 cohorts. Part 1 of the study has been completed. Part 2, the extension phase, which is now ongoing will confirm to safety of the maximum tolerated higher dose from Part 1 and allow a preliminary assessment of efficacy.

Being tested
pEYS606
Keywords
plasmid, electrotransfer, ciliary muscle, uveitis
Medical subject headings
Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pEYS606Biological

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

Study groups in NCT03308045
Study groupRoleWhat they receive
pEYS606ExperimentalCohort 1 (pEYS606 lower dose); Cohort 2 (pEYS606 intermediate dose); Cohort 3 (pEYS606 higher dose); Extension Cohort (pEYS606 maximum tolerated dose)
Receives: Biological: pEYS606

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with treatment emergent adverse events

    Assessment of the safety and tolerability of EYS606

    Measured: 4 weeks

Secondary outcomes (6)

  1. Change from baseline in ocular safety assessments

    Measured as change from baseline in adverse events, concomitant medications, intraocular pressure, electroretinogram, electrocardiogram, vital signs, physical exam and routine labs (blood and urinalysis)

    Measured: 6 months

  2. Improvement in best corrected visual acuity

    Measured as change from baseline eye in best corrected visual acuity using ETDRS scale

    Measured: 6 months

  3. Improvement in anterior chamber cell grade

    Measured as change from baseline in anterior cell grade according to the SUN scale

    Measured: 6 months

  4. Improvement in vitreous haze grade

    Measures as change from baseline in vitreous haze grade according to SUN scale

    Measured: 6 months

  5. Improvement in central retinal thickness

    Measures as change from baseline in central retinal thickness using ocular coherence tomography

    Measured: 6 months

  6. Change in corticosteroid dose

    Measures as change from baseline in prescribed dose of corticosteroids

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2017
  2. Study start4 Apr 2017
  3. Primary completion1 Jun 2021
  4. Study completion1 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Clinical trial with a single arm
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03308045
Sponsor's protocol ID
EYS606-CT1
Status last verified
Mar 2022
First submitted
31 Mar 2017
Last updated
10 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30009894

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing pEYS606 in people with Non-infectious Uveitis, run by Eyevensys at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with treatment emergent adverse events (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03308045, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.

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