Uveitis
Conditions
Keywords
HLA-B27, relapses, curcumin
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.
Interventions
DRUGNorflo Oro
Norflo Oro is highly bioavailable curcumin complexed into phytosomes
DRUGPlacebo for Norflo Oro
Placebo consist of look-alike single foil pouches without active ingredient of Norflo.
Sponsors
Bascom Palmer Eye Institute
Eye Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline | Baseline and 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Side Effects Associated With HLA-B27 Uveitis | 12 months | The changes in side effects associated with HLA-B27 uveitis, such as intraocular pressure (IOP) in the NORFLO® ORO treatment group and control group at the end of the study (12 month) compared to the 12 months before the study started (baseline) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Norflo Oro 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.
Norflo Oro: Norflo Oro is highly bioavailable curcumin complexed into phytosomes | 25 |
| Placebo for Norflo Oro 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.
Placebo for Norflo Oro: Placebo consist of look-alike single foil pouches without active ingredient of Norflo. | 24 |
| Total | 49 |
Baseline characteristics
| Characteristic | Norflo Oro | Placebo for Norflo Oro | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 19 Participants | 41 Participants |
| Age, Continuous | 46.40 years STANDARD_DEVIATION 13.21 | 50.88 years STANDARD_DEVIATION 14.9 | 48.59 years STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 23 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 23 Participants | 48 Participants |
| Region of Enrollment Italy | 19 participants | 19 participants | 38 participants |
| Region of Enrollment Turkey | 3 participants | 3 participants | 6 participants |
| Region of Enrollment United States | 3 participants | 2 participants | 5 participants |
| Relapses Per Patient | 1.95 Relapses STANDARD_DEVIATION 0.94 | 1.50 Relapses STANDARD_DEVIATION 0.83 | 1.71 Relapses STANDARD_DEVIATION 0.94 |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 23 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 24 |
| other Total, other adverse events | 20 / 20 | 19 / 24 |
| serious Total, serious adverse events | 3 / 20 | 0 / 24 |
Outcome results
Primary
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.
Time frame: Baseline and 12 months
Population: Only patients that completed the 12 month study were included in the analysis of the mean number of relapses per patient during the study duration (12 months).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norflo Oro | Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline | 0.35 Relapses Per Patient | Standard Deviation 0.75 |
| Placebo for Norflo Oro | Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline | 0.58 Relapses Per Patient | Standard Deviation 0.88 |
Secondary
Changes in Side Effects Associated With HLA-B27 Uveitis
The changes in side effects associated with HLA-B27 uveitis, such as intraocular pressure (IOP) in the NORFLO® ORO treatment group and control group at the end of the study (12 month) compared to the 12 months before the study started (baseline)
Time frame: 12 months
Population: Only participants that completed the study were included in the 12-month evaluation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Norflo Oro | Changes in Side Effects Associated With HLA-B27 Uveitis | IOP change (right eye) | 0.44 mmHg | Standard Deviation 1.85 |
| Norflo Oro | Changes in Side Effects Associated With HLA-B27 Uveitis | IOP change (left eye) | -0.06 mmHg | Standard Deviation 1.7 |
| Placebo for Norflo Oro | Changes in Side Effects Associated With HLA-B27 Uveitis | IOP change (right eye) | 0.22 mmHg | Standard Deviation 3.01 |
| Placebo for Norflo Oro | Changes in Side Effects Associated With HLA-B27 Uveitis | IOP change (left eye) | -0.09 mmHg | Standard Deviation 2.37 |