A Phase 2 interventional study of EYS606 in Non-infectious Uveitis, sponsored by Eyevensys. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-10.
Sponsored by Eyevensys · Phase 2, Interventional, and Treatment
Among 139 studies in Uveitis with a site in United States — 7 open to participants now, 11 under way, 1 of them phase 3. Uveitis · United States.
Among the 139 studies in Uveitis with a site in United States, this one is the 90th largest by enrollment of the 100 interventional ones, is one of 3 that started in 2020, is one of 28 in phase 2, and was the 118th registered.
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's enrollment of 3 is below the median of 30 across 175 interventional studies indexed under Uveitis.
Browse Uveitis studies →7 of the 139 studies in Uveitis with a site in United States are open now, in 7 countries. Each count lists the studies.
Of the 22 Uveitis studies recruiting now, 13 (59%) set no upper age limit and 9 (41%) stop at 75 or younger; 10 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →139 studies; the count open now beside each. This study's row is marked.
First in 1987; this study’s year is marked. 3 started in 2020.
Median enrollment 19 across the 100 interventional studies, 123 across the 36 observational. Of the 117 that completed or were terminated, 50 (43%) have results posted.
46 of 139 have an industry lead sponsor. The 10 most frequent:
Eyevensys is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Eyevensys has 2 studies filed under Uveitis — fewer than ten, so there is no comparison to draw.
2 of the studies in Uveitis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07518134Jaeb Center for Health ResearchA Study of Uveitis in Children <18 Years of Age | 2027-04-01 |
| NCT04704609The Cleveland ClinicImaging Quantification of Inflammation (IQI) | 2027-04-20 |
Among the 139 studies in Uveitis with a site in United States, from their registry updates:
The objective of the study is to evaluate the efficacy and safety of two different treatment regimens of EYS606.
This is a Phase 2, multi-center, randomized open-label interventional study of EYS606 in subjects with active chronic non-infectious uveitis.
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 will be conducted in 2 parts. Part I is a safety cohort phase that will enroll up to 6 subjects, Part II is the randomized comparison phase that will enroll up to an additional 50 subjects.
Key Eligibility Criteria:
Best corrected visual acuity of
At the screening and baseline visits subject must have active chronic non-infectious uveitis as evidenced by at least one or more of the following in the study eye:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two administrations of EYS606 (135μg pEYS606/90 μL). The frequency between the two administrations will be determined by the DSMB upon completion of the Part I safety cohorts.
Combination Product: EYS606
One administration of EYS606 (135μg pEYS606/90 μL) at the baseline visit (V1).
Combination Product: EYS606
EYS606 is a DNA plasmid solution administered by electrotransfection into the ciliary muscle
Time to rescue therapy between the two EYS606 treatment regimens
Assessment of efficacy measured as time to rescue therapy required after treatment with EYS606
Time frame: Week 24
Proportion (%) of subjects responded to the treatment
Measured as an improvement in anterior cell grade and vitreous haze grade according to the SUN scale, retinal vessel leakage using fluorescein angiography, central retinal thickness using ocular coherence tomography, and an increase in visual acuity using EDTRS compared to baseline
Time frame: Week 8 and 24
Proportion (%) of subjects achieving and maintaining active chronic noninfectious posterior uveitis (CNIU)
Measured as an improvement in anterior cell grade and vitreous haze grade according to the SUN scale, retinal vessel leakage using fluorescein angiography, central retinal thickness using ocular coherence tomography, and an increase in visual acuity using EDTRS compared to baseline
Time frame: Week 24
Median time to control of active CNIU
Measured as an improvement in anterior cell grade and vitreous haze grade according to the SUN scale, retinal vessel leakage using fluorescein angiography, and central retinal thickness using ocular coherence tomography
Time frame: Each Visit up to Week 48
Median time to loss of treatment effect
Measured as an worsening in anterior cell grade and vitreous haze grade according to the SUN scale, retinal vessel leakage using fluorescein angiography, central retinal thickness using ocular coherence tomography, decrease in visual acuity using EDTRS, and any increase in the frequency of dose of specified concomitant medications
Time frame: Each Visit up to Week 48
Median change in visual acuity
Measured in change from baseline in best-corrected visual acuity using EDTRS
Time frame: Each Visit up to Week 48
Plan to share: No
Ran from Feb 2020 to primary completion in Oct 2021, 20 months.
Of 17 phase 2 interventional studies under Uveitis, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 37. This study's 20 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eyevensys