inflammation uveitis
Conditions
Interventions
Patients will receive a single intraocular dose of PP-001.
The study treatment procedure must be performed only by the qualified
Investigator in an operating room, surgical suite, or in an office set
Sponsors
Panoptes Pharma
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients at the age of 18 years and older who have diagnosis of chronic posterior uveitis, intermediate uveitis or panuveitis. 2. Good general state of health (mentally and physically). Laboratory parameters and vital signs of patients must be within the normal ranges. 3. A signed and dated written informed consent form. 4. A signed and dated written data protection consent form. 5. Female patients of childbearing potential must perform a negative urine pregnancy test prior to the injection on the day of the injection visit (Day 0). 6. Male and female patients must ensure that one highly effective method combined with an acceptable method of contraception is used for the entire duration of the study, from first dose up to the study follow-up visit, and refrain from becoming pregnant or fathering a child in the 3 months following the last study drug administration. Male patient must agree with their female partners prior to screening to use the above specified methods of contraception while receiving protocol-specified medication, and for 3 months after stopping the medication 7. Have diagnosis of chronic posterior uveitis, intermediate uveitis or panuveitis (as defined by the Standardization of Uveitis Nomenclature Working Group [Jabs et al., 2005]) in at least one eye. For patients with panuveitis, the anterior component of inflammation must be less than the posterior component. The investigator to his best knowledge must rule out any suspected masquerade syndrome or infection prior to study entry. 8. Have chronic, posterior uveitis, intermediate uveitis or panuveitis requiring treatment. 9. Have media clarity, pupillary dilation and patient cooperation sufficient for adequate visualization of the optic nerve in the study eye. 10. Have been receiving an adequate therapy of e.g. systemic corticosteroid treatment or immunosuppressive therapy (e.g. azathioprine, methotrexate, cyclosporine, mycophenolate, tacrolimus) or any combination thereof. Any systemic therapy at study start should be continued throughout the study. 11. Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity of 10 letters or better (approximately 1/35 or 0.032) but equal or less than 70 letters (approximately 20/40 or 0.5) in the study eye 12. Best-corrected ETDRS visual acuity of 34 letters or better in the fellow eye (approximately 20/200 or 0.1)
Exclusion criteria
Exclusion criteria: 1. Patients in whom media opacities (cornea, anterior or posterior synechia, cataract, vitreous haze and others) of either eye preclude investigation and documentation of the posterior pole and intravenous fluorescein angiography, or optical coherence tomography evaluation in the study eye. 2. Patients receiving any local biologicals. 3. Treatment with cyclophosphamide or chlorambucil. 4. Intravitreal injections (including but not limited to anti-vascular endothelial growth factors) 60 days prior to the baseline. 5. Posterior subtenon's injection or orbital floor injection of steroids 90 days prior to Baseline. 6. Any implantable corticosteroid-eluting device (Ozurdex, Iluvien, Retisert, triamcinolone intravitreal implant, fluocinolone intravitreal implant) in the study eye, with the following exceptions: * If the device had been removed more than 90 days prior to Day 0 of this study, the eye will be eligible for PP-001-1001. * If Ozurdex had been implanted 6 months before Day 0 of this study, the eye will be eligible for PP-001-1001. * If Iluvien or Retisert had been implanted 3 years before Day 0 of this study, the eye will be eligible for PP-001-1001. 7. Intraocular surgery within 90 days prior to Day 0 in the study eye. 8. Capsulotomy within 30 days prior to Day 0 in the study eye. 9. History of vitreoretinal surgery or scleral buckling within 90 days prior to Day 0 in the study eye. 10. Any ocular surgery (including cataract extraction or capsulotomy) of the study eye anticipated within the first 60 days following Day 0. 11. Intraocular pressure (IOP) *25 mmHg in the study eye (glaucoma patients maintained on no more than one topical medication with IOP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary * Safety parameters (i.e., changes in clinical signs and symptoms from ophthalmic exam, and AEs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary * Improvement of inflammation or of any other parameter determined at the ophthalmic examination following the injection of PP-001 * The concentration of PP-001 in plasma at Screening, 4 h ± 1 h after dosing and on Day 2 | — |
Countries
Netherlands
Outcome results
None listed