A safety study of intravitreal PP-001 in patients with chronic, non-infectious uveitis having chronic inflammatio

Withdrawn

Conditions: inflammation
uveitis
10015919

Registration Number: NL-OMON48871

Lead Sponsor: Panoptes Pharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 5

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

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 <25 mmHg are allowed
to participate).
12. Ocular hypotonia (IOP less than 6 mmHg).
13. Pupillary dilation inadequate for quality fundus photography in the study
eye.
14. Aphakia or anterior chamber lens in the study eye.
15. Visible scleral thinning, scleral ectasia or keratoconus in the study eye.
16. Presence of any ocular malignancy.
17. Ocular or periocular infection in either eye or the use of systemic
antibiotics.
18. Participation in other investigational drug or device clinical trials
within 90 days prior to Day 0, or planning to participate in other
investigational drug or device clinical trials within 180 days following Day 0.
This includes both ocular and non-ocular clinical trials.
19. Female patients who are pregnant, nursing, or planning a pregnancy, or who
are of childbearing potential and not willing to use reliable means of
contraception.
20. Use of any anticoagulant or thrombocyte aggregation inhibiting agent
(marcumar, warfarin, heparin, enoxaparin, apixaban, rivaroxaban,
pentosanpolysulfate, dabigatran) less than 7 days prior to injection visit (Day
0).
21. Known allergy or hypersensitivity to the study medication, any component of
the delivery vehicle, any corticosteroids or any diagnostic agents used during
the study (e.g., fluorescein, dilation drops, antibiotic drops, povidone).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary<br /><br>* Safety parameters (i.e., changes in clinical signs and symptoms from<br /><br>ophthalmic exam, and AEs)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary<br /><br>* Improvement of inflammation or of any other parameter determined at the<br /><br>ophthalmic examination following the injection of PP-001<br /><br>* The concentration of PP-001 in plasma at Screening, 4 h ± 1 h after dosing<br /><br>and on Day 2</p><br>