A Phase 3 interventional study of 4mg CLS-TA Suprachoriodal Injection and Sham Procedure in Uveitis, Uveitis, Posterior and Uveitis, Anterior, sponsored by Clearside Biomedical, Inc.. Completed at 64 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-28.
Sponsored by Clearside Biomedical, Inc. · Phase 3, Interventional, and Treatment
The study is designed to evaluate the safety and efficacy of suprachoroidally administered triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with non-infectious uveitis.
This is a Phase 3, randomized, masked, sham-controlled, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham injection procedure in the treatment of subjects with macular edema associated with non-infectious uveitis.
Qualified subjects will be randomized to receive two suprachoroidal injections of CLS-TA administered to the study eye or two sham injection procedures administered to the study eye approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted monthly up to 24 weeks (Visit 8).
Exclusion Criteria:
Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
Drug: 4mg CLS-TA Suprachoriodal Injection
Matching suprachoroidal syringe with sham procedure
Drug: Sham Procedure
CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints
Also known as: Triamcinolone Acetonide
Sham procedure administered at 2 timepoints
Also known as: suprachoroidal sham
Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on electronic Visual Acuity (eVA). An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
Time frame: Baseline, 24 weeks
Mean Change From Baseline in Central Subfield Thickness
Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. Only images that were gradable by the central reading center were included in the analysis.
Time frame: Baseline, 24 weeks
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of subjects with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) reported between the first dose of study drug and study exit.
Time frame: Baseline to 24 weeks
| Milestone | 4mg CLS-TA Suprachoriodal Injection | Sham Procedure |
|---|---|---|
| Started | 96 | 64 |
| Intention-to-treat (itt) population | 96 | 64 |
| Safety population | 96 | 64 |
| Completed | 92 | 63 |
| Not completed | 4 | 1 |
| Withdrew: Non-compliance | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on electronic Visual Acuity (eVA). An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
| Participants | 4mg CLS-TA Suprachoriodal Injection | Sham Procedure |
|---|---|---|
| Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks | 45 | 10 |
Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. Only images that were gradable by the central reading center were included in the analysis.
| microns | 4mg CLS-TA Suprachoriodal Injection | Sham Procedure |
|---|---|---|
| Mean Change From Baseline in Central Subfield Thickness | -152.6 ± 159.14 | -17.9 ± 150.98 |
Number of subjects with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) reported between the first dose of study drug and study exit.
| Participants | 4mg CLS-TA Suprachoriodal Injection | Sham Procedure |
|---|---|---|
| Experiencing at least one TEAE | 67 | 45 |
| Experiencing at least one SAE | 3 | 0 |
Collected over Adverse events were collected over 24 weeks of follow-up.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 4mg CLS-TA Suprachoriodal Injection | 0/96 (0%) | 3/96 (3.1%) | 42/96 (43.8%) |
| Sham Procedure | 0/64 (0%) | 0/64 (0%) | 29/64 (45.3%) |
| Event | 4mg CLS-TA Suprachoriodal Injection | Sham Procedure |
|---|---|---|
| SialoadenitisInfections and infestations | 1/96 | 0/64 |
| Lumbar vertebral fractureInjury, poisoning and procedural complications | 1/96 | 0/64 |
| Retinal detachmentEye disorders | 1/96 | 0/64 |
| Event | 4mg CLS-TA Suprachoriodal Injection | Sham Procedure |
|---|---|---|
| Intraocular pressure increasedInvestigations | 17/96 | 4/64 |
| Eye painEye disorders | 14/96 | 0/64 |
| Cystoid macular oedemaEye disorders | 0/96 | 9/64 |
| Ocular hypertensionEye disorders | 2/96 | 5/64 |
| Cataract subcapsularEye disorders | 7/96 | 3/64 |
| UveitisEye disorders | 2/96 | 4/64 |
| Intraocular pressure increasedInvestigations | 6/96 | 2/64 |
| HeadacheNervous system disorders | 5/96 | 2/64 |
The Intent-to-treat population included all randomized subjects who received at least one study treatment.
| Age, Categorical(Participants) | 4mg CLS-TA Suprachoriodal Injection | Sham Procedure | Total |
|---|---|---|---|
| <=18 years | 1 | 0 | 1 |
| Between 18 and 65 years | 79 | 52 | 131 |
| >=65 years | 16 | 12 | 28 |
| Age, Continuous(years) | 4mg CLS-TA Suprachoriodal Injection | Sham Procedure | Total |
|---|---|---|---|
| Mean | 50.40 ± 14.180 | 50.00 ± 15.083 | 50.24 ± 14.502 |
| Sex: Female, Male(Participants) | 4mg CLS-TA Suprachoriodal Injection | Sham Procedure | Total |
|---|---|---|---|
| Female | 54 | 34 | 88 |
| Male | 42 | 30 | 72 |
| Ethnicity (NIH/OMB)(Participants) | 4mg CLS-TA Suprachoriodal Injection | Sham Procedure | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 6 | 16 |
| Not Hispanic or Latino | 86 | 58 | 144 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 4mg CLS-TA Suprachoriodal Injection | Sham Procedure | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 44 | 28 | 72 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 11 | 22 |
| White | 40 | 25 | 65 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | 4mg CLS-TA Suprachoriodal Injection | Sham Procedure | Total |
|---|---|---|---|
| United States | 46 | 34 | 80 |
| Israel | 7 | 3 | 10 |
| India | 43 | 27 | 70 |
| Type of Uveitis(Participants) | 4mg CLS-TA Suprachoriodal Injection | Sham Procedure | Total |
|---|---|---|---|
| Anterior uveitis | 27 | 14 | 41 |
| Intermediate uveitis | 34 | 23 | 57 |
| Posterior uveitis | 22 | 13 | 35 |
| Panuveitis | 28 | 24 | 52 |
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Clearside Biomedical, Inc.