A Phase 2 interventional study of 4 mg CLS-TA and 0.8 mg CLS-TA in Uveitis, Macular Edema and Uveitis, Posterior, sponsored by Clearside Biomedical, Inc.. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-08.
Sponsored by Clearside Biomedical, Inc. · Phase 2, Interventional, and Treatment
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.
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.
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's enrollment of 22 is below 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.
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Exclusion Criteria:
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
Drug: 4 mg CLS-TA
Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA
Drug: 0.8 mg CLS-TA
40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
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
| Milestone | 4 mg CLS-TA | 0.8 mg CLS-TA |
|---|---|---|
| Started | 17 | 5 |
| Completed | 17 | 5 |
| Not completed | 0 | 0 |
| Microns | 4 mg CLS-TA | 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 | -164.44 ± 173.148 | -78.20 ± 121.890 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 4 mg CLS-TA | 0/17 (0%) | 1/17 (5.9%) | 14/17 (82.4%) |
| 0.8 mg CLS-TA | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Event | 4 mg CLS-TA | 0.8 mg CLS-TA |
|---|---|---|
| Atrial fibrillationCardiac disorders | 1/17 | 0/5 |
| Event | 4 mg CLS-TA | 0.8 mg CLS-TA |
|---|---|---|
| Macular oedemaEye disorders | 0/17 | 3/5 |
| Conjunctival haemorrhageEye disorders | 1/17 | 2/5 |
| Anterior chamber inflammationEye disorders | 0/17 | 1/5 |
| Blindness transientEye disorders | 0/17 | 1/5 |
| Macular oedemaEye disorders | 2/17 | 1/5 |
| Retinal artery occlusionEye disorders | 0/17 | 1/5 |
| UveitisEye disorders | 1/17 | 1/5 |
| Injection site painGeneral disorders | 1/17 | 1/5 |
| Tooth infectionInfections and infestations | 0/17 | 1/5 |
| Upper respiratory tract infectionInfections and infestations | 0/17 | 1/5 |
Intent-to-Treat set includes all randomly assigned subjects who received at least one dose of study drug.
| Age, Categorical(Participants) | 4 mg CLS-TA | 0.8 mg CLS-TA | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 4 | 17 |
| >=65 years | 4 | 1 | 5 |
| Age, Continuous(Years) | 4 mg CLS-TA | 0.8 mg CLS-TA | Total |
|---|---|---|---|
| Mean | 52.2 ± 19.65 | 51.8 ± 16.87 | 52.1 ± 18.67 |
| Sex: Female, Male(Participants) | 4 mg CLS-TA | 0.8 mg CLS-TA | Total |
|---|---|---|---|
| Female | 8 | 4 | 12 |
| Male | 9 | 1 | 10 |
| Region of Enrollment(participants) | 4 mg CLS-TA | 0.8 mg CLS-TA | Total |
|---|---|---|---|
| United States | 17 | 5 | 22 |
Plan to share: No
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Clearside Biomedical, Inc.