Non-Infectious Uveitis affecting the posterior segment MedDRA version: 20.1 Level: LLT Classification code 10036370 Term: Posterior uveitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: ILUVIEN 190 micrograms intravitreal implant in applicator
Product Name: ILUVIEN 190 micrograms intravitreal implant in applicator
Pharmaceutical Form: Intravitreal implant in applicator
IN
Sponsors
Alimera Sciences Europe Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females of =6 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of intraocular surgery in the study eye within 90 days of the screening visit 2. Hypersensitivity to FA or any component of ILUVIEN® 3. History of any form of glaucoma or ocular hypertension in study eye, unless study eye has been previously treated with an incisional IOP-lowering surgical procedure at least 90 days prior to the screening visit and that procedure has resulted in stable IOP in the normal range (10-21 mmHg)) 4. Increased intraocular pressure >25 mmHg or that required treatment including increases in medications, surgery (other than drainage surgery), or hospitalisations, within 4 weeks prior to baseline that, in the opinion of the Investigator, would pose an unacceptable risk to the patient participating in the study 5. Best corrected visual acuity (BCVA) 0.15 mg/kg daily) or systemic immunosuppressive therapy for autoimmune conditions other than Juvenile Idiopathic Arthritis, Blau syndrome, Idiopathic Chronic Anterior Uveitis, Intermediate Uveitis, Idiopathic Panuveitis 26. History of certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to Day 1 27. Systemic infection within 30 days prior to Day 1 28. Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the Investigator, could make the subject inappropriate for entry into this study 29. Any other systemic or ocular condition which, in the judgment of the Investigator, could make the subject inappropriate for entry into this study 30. Treatment with an investigational drug or device within 3 months prior to Day 1 31. Pregnant or nursing females; females of child
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety and efficacy of ILUVIEN® 190µg in paediatric subjects with recurrent non-infectious uveitis affecting the posterior segment of the eye;Secondary Objective: 1.To assess the incidence of recurrence of non-infectious uveitis affecting the posterior segment in the study eye 2.To evaluate the incidence and onset of secondary lens opacity and extraction 3.To assess the incidence of secondary intraocular pressure (IOP) elevation ;Primary end point(s): Primary Efficacy Endpoints: Treatment success based on: 1.Absence of cystoid macular oedema on Optical Coherence Tomography AND 2.A decrease from baseline in vitreous haze grade =2 steps, or absence of vitreous haze Primary Safety Endpoints: •Rate of cataract formation •Rate of IOP elevation (Change from baseline in IOP and incidence of significant changes in IOP, including: IOP>21 mmHg, IOP>25 mmHg, IOP>30 mmHg, increases from baseline of 10 mmHg or more). ;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints 1. Absence of cystoid macular oedema and decrease from baseline in vitreous haze grade of =2 steps, or absence of vitreous haze at completion of the study 2. Uveitis recurrence rate following treatment, compared to the uveitis recurrence rate over the 12 months prior to enrolment 3. The incidence of recurrence of non-infectious uveitis affecting the posterior segment in the study eye and in the fellow eye after receiving study treatment 4. The time to recurrence of non-infectious uveitis affecting the posterior segment in the study eye 5. Change in macular oedema 6. Change in Best Corrected Visual Acuity 7. Change in vitreous haze 8. Change in anterior chamber cell grade 9. Incidence of secondary increase in IOP 10. Incidence of secondary increase in IOP requiring surgical intervention 11. Incidence and onset of secondary lens opacity and extraction 12. Number of adjunctive treatments required to treat recurrences of uveitis 13. Presence of active chorioretinal and retinal vascular lesions 14. Incidence of ocular infection 15. Change from baseline in cup-to-disc ratio 16. Incidence of ocular and non-ocular adverse events (AEs) Secondary Safety Endpoints: • Incidence of secondary increase in IOP • Incidence of secondary increase in IOP requiring surgical intervention • Incidence of ocular and non-ocular AEs. ;Timepoint(s) of evaluation of this end point: 3 years | — |
Countries
European Union, Germany, Spain, United Kingdom
Contacts
Public ContactProject Management
AMS Advanced Medical Services GmbH
Outcome results
None listed