Assessment of the Anti-inflammatory Effects of Norflo Oro in Acute Relapses of HLA-B27 Associated Autoimmune Uveitis

NCT03584724 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: Norflo-Oro-16
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveitis

Keywords

HLA-B27; relapses; curcumin

Outcome Measures

Primary Outcomes (1)

• Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline

  The mean number of uveitis relapses per patient in the 12 months of study duration (12 months) will be compared to the average number of uveitis relapses per patient in the 12 months before (baseline) for the Norflo Oro group and for the Placebo group.

  Baseline and 12 months

Secondary Outcomes (1)

• Changes in Side Effects Associated With HLA-B27 Uveitis

  12 months

Study Arms (2)

Norflo Oro

EXPERIMENTAL

The study subject will take the entire content of one packet of Norflo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits.

Drug: Norflo Oro

Placebo for Norflo Oro

PLACEBO COMPARATOR

The study subject will take the entire content of one packet of Placebo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits.

Drug: Placebo for Norflo Oro

Interventions

Norflo Oro DRUG

Norflo Oro is highly bioavailable curcumin complexed into phytosomes

Also known as: Meriva

Norflo Oro

Placebo for Norflo Oro DRUG

Placebo consist of look-alike single foil pouches without active ingredient of Norflo.

Also known as: Placebo

Placebo for Norflo Oro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye Pharma: lead
• Bascom Palmer Eye Institute: collaborator

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Related Publications (4)

• 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.

  PMID: 21060672 BACKGROUND

• 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.

  PMID: 23241930 BACKGROUND

• 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.

  PMID: 23723686 BACKGROUND

• 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.

  PMID: 35353651 DERIVED

MeSH Terms

Conditions

Uveitis; Recurrence

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Elena Meloni
• Organization: Eye Pharma

elena.meloni@eyepharma.com

7862187339

Study Officials

• Pia Allegri

  S.S. Uveitis Center, Rapallo Hospital, Genoa- Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Up to 60 eligible patients will be randomly assigned to NORFLO® ORO or placebo treatment groups in a 1:1 ratio using a stratified randomization blocks scheme.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: July 12, 2018
• Study Start: December 19, 2018
• Primary Completion: August 20, 2020
• Study Completion: December 30, 2020
• Last Updated: March 28, 2022
• Results First Posted: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)