Clinical trial NCT03584724: Assessment of the Anti-inflammatory Effects of Norflo Oro in Acute Relapses of HLA-B27 Associated Autoimmune Uveitis
Official title: Assessment of the Anti-inflammatory Effects of Norflo Oro in Acute Relapses of HLA-B27 Associated Autoimmune Uveitis: a Multicenter Randomized, Placebo Controlled, Double-blind Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Uveitis
Keywords: HLA-B27
relapses
curcumin
Lead sponsor: Eye Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bascom Palmer Eye Institute
First posted: 2018-07-12
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the efficacy of Norflo Oro in the treatment of relapsing autoimmune uveitis (RAU), measured as a long term reduction of the frequency and the severity of relapses, in patients with HLA-B27 associated uveitis, under conditions of routine medical practice. The reduction of the mean number of relapses per patient between the year before study treatment and the study period will also be assessed.

Detailed description: The secondary objective of this study will be: (i) evaluation of the improvement of side effects due to HLA-B27 associated uveitis such as intraocular pressure (IOP), cystoid macular edema, keratophaty and synechia (ii) evaluation of the improvement in uveitis-related symptoms: BCVA and symptoms measured by VAS, like ocular pain, photophobia, floaters and blurred vision; (iii) evaluation of cell damage and inflammation reduction in patients with HLA-B27 associated uveitis; (iv) evaluation of the patients' attitude towards the study treatment and also the evaluation of the safety profile of the study product.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of HLA-B27 positive related uveitis in non- acute phase
* At least one autoimmune uveitis relapse

Exclusion Criteria:

* Use of supplements (nutraceuticals) or systemic therapy for uveitis with anti-inflammatory immunosuppressive or biological drugs within last 30 days
* Anticipated need for systemic anti-inflammatory treatment during the study
* Use of intravitreal peribulbar, sub-tenon, periocular injection in the previous 6 months
* Long-term treatment with a systemic anti-inflammatory, immune suppressant drugs
* Woman taking hormonal contraceptives, pregnant or breastfeeding.

Primary outcomes:
measure: Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Changes in Side Effects Associated With HLA-B27 Uveitis
timeFrame: 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: S.S. Uveitis Center, Rapallo Hospital, Genoa- Italy
name: Pia Allegri
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allegri P, Mastromarino A, Neri P. Management of chronic anterior uveitis relapses: efficacy of oral phospholipidic curcumin treatment. Long-term follow-up. Clin Ophthalmol. 2010 Oct 21;4:1201-6. doi: 10.2147/OPTH.S13271.
citation: Steigerwalt R, Nebbioso M, Appendino G, Belcaro G, Ciammaichella G, Cornelli U, Luzzi R, Togni S, Dugall M, Cesarone MR, Ippolito E, Errichi BM, Ledda A, Hosoi M, Corsi M. Meriva(R), a lecithinized curcumin delivery system, in diabetic microangiopathy and retinopathy. Panminerva Med. 2012 Dec;54(1 Suppl 4):11-6.
citation: Mazzolani F, Togni S. Oral administration of a curcumin-phospholipid delivery system for the treatment of central serous chorioretinopathy: a 12-month follow-up study. Clin Ophthalmol. 2013;7:939-45. doi: 10.2147/OPTH.S45820. Epub 2013 May 22.
citation: Allegri P, Cimino L, Davis JL, Tugal-Tutkun I; Norflo Oro study group. Assessment of the Anti-inflammatory Effects of NORFLO(R) ORO in Acute Relapses of HLA-B27-associated Autoimmune Uveitis: A Multicenter, Randomized, Placebo-controlled, Double-blind Clinical Study. Ocul Immunol Inflamm. 2023 Apr;31(3):526-535. doi: 10.1080/09273948.2022.2039210. Epub 2022 Mar 30.