Macular Edema, Panuveitis, Uveitis, Uveitis, Anterior, Uveitis, Intermediate, Uveitis, Posterior
Conditions
Keywords
uveitis, macular edema, UME, posterior uveitis, anterior uveitis, panuveitis, intermediate uveitis, noninfectious uveitis, triamcinolone acetonide, suprachoroidal space, injection, microneedle, intravitreal injection, corticosteroid, CME, choroid, retina, microinjection, SCS
Brief summary
The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA, in subjects with macular edema following non-infectious uveitis. A single suprachoroidal injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema following non-infectious uveitis.
Detailed description
This is a Phase 2, randomized, masked, multicenter study to assess the safety and efficacy of two different doses of CLS-TA in the treatment of subjects with macular edema following non-infectious uveitis. Each subject will receive a single suprachoroidal injection of CLS-TA. The subjects enrolled in this study will be chosen from subjects with macular edema following non-infectious uveitis. A single injection will be administered via the Clearside microinjector into the suprachoroidal space. The dose injected will either be 4 mg or 0.8 mg of CLS-TA in a total volume of 100 μL. The dose they receive will depend on what their randomization code dictates. Subjects will be monitored for safety and efficacy for approximately 8 weeks following treatment.
Interventions
DRUG4 mg CLS-TA
40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
DRUG0.8 mg CLS-TA
8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
Sponsors
Clearside Biomedical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of noninfectious uveitis * diagnosis of macular edema associated with noninfectious uveitis
Exclusion criteria
* any ocular trauma within the immediate 6 months prior to treatment * any photocoagulation or cryotherapy in the 6 months prior to treatment * any IVT injection of anti-VEGF treatment in the 2 months prior to treatment * any eye diseases other than uveitis and ME that could compromise central visual acuity * any previous suprachoroidal injection of triamcinolone acetonide in the study eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis | 2 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 4 mg CLS-TA Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) | 17 |
| 0.8 mg CLS-TA Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA
0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) | 5 |
| Total | 22 |
Baseline characteristics
| Characteristic | 0.8 mg CLS-TA | 4 mg CLS-TA | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 13 Participants | 17 Participants |
| Age, Continuous | 51.8 Years STANDARD_DEVIATION 16.87 | 52.2 Years STANDARD_DEVIATION 19.65 | 52.1 Years STANDARD_DEVIATION 18.67 |
| Region of Enrollment United States | 5 participants | 17 participants | 22 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 1 Participants | 9 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 5 |
| other Total, other adverse events | 14 / 17 | 5 / 5 |
| serious Total, serious adverse events | 1 / 17 | 0 / 5 |
Outcome results
Primary
Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis
Time frame: 2 months
Population: Intent-to-Treat set includes all randomly assigned subjects who received at least one dose of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4 mg CLS-TA | Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis | -164.44 Microns | Standard Deviation 173.148 |
| 0.8 mg CLS-TA | Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis | -78.20 Microns | Standard Deviation 121.89 |
Comparison: A paired t-test was used to assess the statistical significance of the change between Baseline and Month 2.~A sample size of 16 subjects would have 80% power to detect a difference of 75, assuming a standard deviation of 100, using a paired t-test with a 0.050 two-sided significance level.p-value: 0.001795% CI: [-256.7, -72.2]Paired t-test, two-sided