Ixekizumab for the Management of Refractory Non-Infectious Uveitis: A Proof-of-Concept Study
Status unconfirmed · Phase 4
Conditions studied: Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate, Panuveitis
In brief
The objective of this study is to explore the efficacy of ixekizumab in treating patients with a diagnosis of non-infectious intermediate, posterior, panuveitis, or chronic steroid-dependent anterior uveitis who had failed treatment with a classic synthetic DMARD including methotrexate, mycophenolate, cyclosporin, azathioprine, cyclophosphamide and/or at least one anti-TNF agent including adalimumab, infliximab, etanercept, golimumab or certolizumab.
Key facts
- Study ID
- NCT06085079
- Run by
- Massachusetts Eye Research and Surgery Institution
- People needed
- 20
- Starts
- 2022-06-01
- Expected to finish
- 2024-12-30
- Last updated by the study team
- 2023-10-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- At least 18 years of age
- Diagnosis of non-infectious intermediate, posterior, panuveitis, or chronic steroid dependent anterior uveitis
- Failure of at least one classic synthetic DMARD including Methotrexate, Mycophenolate, Cyclosporin, Azathioprine, Cyclophosphamide, and/or at least one anti-TNF agent including Adalimumab, Infliximab, Etanercept, Golimumab or Certolizumab
- Active disease at screening visit
- At least 1 of the following parameters in at least one eye:
- active inflammatory chorioretinal and/or inflammatory retinal vascular lesions
- ≥ 1+ vitreous haze (Nussenblatt criteria)
- ≥ 2+ anterior chamber cells (National Eye Institute/Standardization of Uveitis Nomenclature criteria)
- Cystoid macular edema, seen on optical coherence tomography and/or fluorescein angiography
- FA leakage pattern deemed by investigators to be suggestive of active intermediate, posterior, and panuveitis, including optic disc, retinal vascular, and macular leakages
- Active snowbanking
You may not qualify if…
- The presence of only acute anterior uveitis.
- Serpiginous choroidopathy
- Subject with prior inadequate response to high-dose oral corticosteroids (> 60 mg of prednisone)
- Subject with confirmed or suspected infectious uveitis
- Patients with intraocular pressure of ≥ 25 mmHg or evidence of optic nerve injury
- Corneal or lens opacity that precludes adequate ophthalmic evaluation.
- Patients likely to undergo cataract surgery during the duration of the trial.
- Patients with Best Corrected Visual Acuity (BCVA) less than 20 letters (Early Treatment Diabetic Retinopathy Study)
- Dose of concomitant immunosuppressive therapy at the baseline visit:
- Methotrexate (MTX) ˃ 25 mg per week
- Cyclosporine ˃ 4 mg/kg per day
- Mycophenolate mofetil ˃ 3 grams per day or an equivalent drug to mycophenolate mofetil (e.g. mycophenolic acid) at an equivalent dose approved by the medical monitor.
- Azathioprine ˃ 175 mg per day
- Tacrolimus (oral formulation) > 8 mg per day
- If entering the study on 1 concomitant immunosuppressive therapy, dose has been increased within the last 28 days prior to Baseline visit.
- Subject has received Retisert® (implant) within 3 years prior to the Baseline visit or that has had complications related to the device. Subject has had Retisert® (implant) removed within 90 days prior to the Baseline visit or has had complications related to the removal of the device
- Subject has received intraocular or periocular corticosteroids within 30 days prior to Baseline visit
- Subject with proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy
- Subject with neovascular/wet age-related macular degeneration
- Subject with abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process, deemed macular pathology is deemed by a retinal specialist to be a potential cofounder of patient's visual acuity reduction
- Subject with severe vitreous haze that precludes visualization of the fundus at the baseline visit
- Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the baseline visit
- Subject has received intravitreal anti-VEGF therapy within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within 60 days of the Baseline visit for anti-VEGF Trap (aflibercept)
- Subject has received intravitreal methotrexate within 90 days prior to the Baseline visit
- Subject on systemic carbonic anhydrase inhibitor within 1 week prior to Screening visit
Where it is running
- Massachusetts Eye Research and Surgery Institution — Waltham, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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