A Phase 3 interventional study of 4 mg CLS-TA Suprachoriodal Injection in Uveitis, Uveitis, Posterior and Uveitis, Anterior, sponsored by Clearside Biomedical, Inc.. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-23.
Sponsored by Clearside Biomedical, Inc. · Phase 3, Interventional, and Treatment
This open-label study is designed to evaluate the safety of suprachoroidally administered triamcinolone acetone injectable suspension, CLS-TA, in patients with non-infectious uveitis with and without macular edema.
This is a Phase 3, open-label multicenter study to assess the safety of 4 mg of CLS-TA administered via suprachoroidal injection in the treatment of patients diagnosed with noninfectious uveitis with and without macular edema.
Qualified patients will be enrolled and receive two suprachoroidal injections of CLS-TA 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).
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's enrollment of 38 is above the median of 30 across 175 interventional studies indexed under Uveitis.
Browse Uveitis studies →Clearside Biomedical, Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA
Drug: 4 mg CLS-TA Suprachoriodal Injection
CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
Also known as: Triamcinolone Acetonide
Adverse Events
Number of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a preexisting medical condition after or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A TEAE is an AE occurring on or after the date of the first dose of study drug or worsening relative to the pre-treatment state. An SAE is an AE that fulfils one or more of the following: results in death; is immediately life-threatening; requires hospitalization nor prolongation of hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event that may jeopardize the subject or may require medical intervention to present one of the outcomes listed above.
Time frame: Baseline to 24 weeks
Mean Intraocular Pressure in the Study Eye
Intraocular pressure is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine this. IOP is an important aspect in the evaluation of patients at risk of glaucoma. Tonometers in this study were calibrated to measure pressure in millimeters of mercury.
Time frame: Baseline, 24 Weeks
Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye
The anterior chamber is the aqueous humor-filled space inside the eye between the iris and the cornea's innermost surface, the endothelium. The grading of cellular reaction in the anterior chamber helps in the assessment of the severity of uveitis. In this study, anterior chamber cells were graded following the Standardization of Uveitis Nomenclature working group recommendations. The following scale was used to grade the cells in the field: 0 = \<1, 0.5+ = 1-5, 1+ = 6-15, 2+ = 16-25, 3+ = 26-50, and 4+ = \>50 cells. A lower grade represents less inflammation in the eye.
Time frame: Baseline, 24 Weeks
Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye
The anterior chamber is the aqueous humor-filled space inside the eye between the iris and the cornea's innermost surface, the endothelium. The grading of intraocular inflammation or flare in the anterior chamber helps in the assessment of the severity of uveitis. In this study, anterior chamber flare was graded following the Standardization of Uveitis Nomenclature working group recommendations. The following scale was used to grade the flare: 0 = none, 1+ = faint, 2+ moderate (iris and lens details clear), 3+ = marked (iris and lens details hazy), 4+ = intense (fibrin or plastic aqueous). A lower grade represents less inflammation in the eye.
Time frame: Baseline, 24 Weeks
Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye
The vitreous body is that part of the eye that fills the space in the center of the eye. The primary purpose of the vitreous body is to keep the center of the eye clear so that light can get to the retina and vision can begin. Vitreous haze involves the obstruction of the back of the eye by vitreous cells and protein exudation. In this study, vitreous haze was graded following a standardized photographic scale ranging from 0 to 4. The following scale was used to grade the vitreous haze: 0 = no inflammation, +0.5 = trace inflammation, +1 = mild blurring of the retinal vessels and optic nerve, +1.5 = optic nerve head and posterior retina view obscuration greater than +1 but less than +2, +2 = moderate blurring of the optic nerve head, +3 = marked blurring of the optic nerve head, +4 = optic nerve head not visible. A lower grade represents less inflammation in the eye.
Time frame: Baseline, 24 Weeks
| Milestone | 4 mg CLS-TA Suprachoriodal Injection |
|---|---|
| Started | 38 |
| Intention-to-treat population | 38 |
| Safety population | 38 |
| Completed | 37 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
Number of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a preexisting medical condition after or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A TEAE is an AE occurring on or after the date of the first dose of study drug or worsening relative to the pre-treatment state. An SAE is an AE that fulfils one or more of the following: results in death; is immediately life-threatening; requires hospitalization nor prolongation of hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event that may jeopardize the subject or may require medical intervention to present one of the outcomes listed above.
| Participants | 4 mg CLS-TA Suprachoriodal Injection |
|---|---|
| Treatment-Emergent Adverse Events | 27 |
| Serious Adverse Events | 1 |
Intraocular pressure is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine this. IOP is an important aspect in the evaluation of patients at risk of glaucoma. Tonometers in this study were calibrated to measure pressure in millimeters of mercury.
| mmHg | 4 mg CLS-TA Suprachoriodal Injection |
|---|---|
| Baseline | 13.3 ± 3.57 |
| Week 24 | 15.2 ± 4.40 |
The anterior chamber is the aqueous humor-filled space inside the eye between the iris and the cornea's innermost surface, the endothelium. The grading of cellular reaction in the anterior chamber helps in the assessment of the severity of uveitis. In this study, anterior chamber cells were graded following the Standardization of Uveitis Nomenclature working group recommendations. The following scale was used to grade the cells in the field: 0 = \<1, 0.5+ = 1-5, 1+ = 6-15, 2+ = 16-25, 3+ = 26-50, and 4+ = \>50 cells. A lower grade represents less inflammation in the eye.
| Participants | 4 mg CLS-TA Suprachoriodal Injection |
|---|---|
| Baseline | 17 |
| Week 24 | 31 |
The anterior chamber is the aqueous humor-filled space inside the eye between the iris and the cornea's innermost surface, the endothelium. The grading of intraocular inflammation or flare in the anterior chamber helps in the assessment of the severity of uveitis. In this study, anterior chamber flare was graded following the Standardization of Uveitis Nomenclature working group recommendations. The following scale was used to grade the flare: 0 = none, 1+ = faint, 2+ moderate (iris and lens details clear), 3+ = marked (iris and lens details hazy), 4+ = intense (fibrin or plastic aqueous). A lower grade represents less inflammation in the eye.
| Participants | 4 mg CLS-TA Suprachoriodal Injection |
|---|---|
| Baseline | 27 |
| Week 24 | 34 |
The vitreous body is that part of the eye that fills the space in the center of the eye. The primary purpose of the vitreous body is to keep the center of the eye clear so that light can get to the retina and vision can begin. Vitreous haze involves the obstruction of the back of the eye by vitreous cells and protein exudation. In this study, vitreous haze was graded following a standardized photographic scale ranging from 0 to 4. The following scale was used to grade the vitreous haze: 0 = no inflammation, +0.5 = trace inflammation, +1 = mild blurring of the retinal vessels and optic nerve, +1.5 = optic nerve head and posterior retina view obscuration greater than +1 but less than +2, +2 = moderate blurring of the optic nerve head, +3 = marked blurring of the optic nerve head, +4 = optic nerve head not visible. A lower grade represents less inflammation in the eye.
| Participants | 4 mg CLS-TA Suprachoriodal Injection |
|---|---|
| Baseline | 17 |
| Week 24 | 34 |
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 |
|---|---|---|---|
| 4 mg CLS-TA Suprachoriodal Injection | 0/38 (0%) | 1/38 (2.6%) | 24/38 (63.2%) |
| Event | 4 mg CLS-TA Suprachoriodal Injection |
|---|---|
| Visual acuity reducedEye disorders | 1/38 |
| Event | 4 mg CLS-TA Suprachoriodal Injection |
|---|---|
| Conjunctival haemorrhageEye disorders | 5/38 |
| Intraocular pressure increasedInvestigations | 4/38 |
| Intraocular pressure increasedInvestigations | 4/38 |
| Eye painEye disorders | 3/38 |
| Procedure headacheInjury, poisoning and procedural complications | 3/38 |
| Eye inflammationEye disorders | 2/38 |
| Eye inflammationEye disorders | 2/38 |
| Ocular hypertensionEye disorders | 2/38 |
| Visual acuity reducedEye disorders | 2/38 |
| CataractEye disorders | 2/38 |
The Safety Population included all patients who entered the study and were administered at least one dose of CLS-TA
| Age, Categorical(Participants) | 4 mg CLS-TA Suprachoriodal Injection |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 25 |
| >=65 years | 13 |
| Age, Continuous(years) | 4 mg CLS-TA Suprachoriodal Injection |
|---|---|
| Mean | 52.4 ± 15.8 |
| Sex: Female, Male(Participants) | 4 mg CLS-TA Suprachoriodal Injection |
|---|---|
| Female | 25 |
| Male | 13 |
| Ethnicity (NIH/OMB)(Participants) | 4 mg CLS-TA Suprachoriodal Injection |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 33 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | 4 mg CLS-TA Suprachoriodal Injection |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 31 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | 4 mg CLS-TA Suprachoriodal Injection |
|---|---|
| United States | 38 |
| Type of Uveitis in the Study Eye(Participants) | 4 mg CLS-TA Suprachoriodal Injection |
|---|---|
| Anterior uveitis | 12 |
| Intermediate uveitis | 15 |
| Posterior uveitis | 10 |
| Panuveitis | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2017 to primary completion in Jan 2018, 9 months.
Results were first posted in Jun 2021, 3 years 4 months after primary completion. A results delay was requested in Sep 2018.
Of 15 phase 3 interventional studies under Uveitis, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 55. This study's 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Triamcinolone Acetonide
Clearside Biomedical, Inc.