Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis (DOGWOOD)
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| ClinicalTrials.gov Identifier: NCT02255032 |
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Recruitment Status :
Completed
First Posted : October 2, 2014
Results First Posted : February 8, 2021
Last Update Posted : February 8, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Uveitis Macular Edema Uveitis, Posterior Uveitis, Anterior Panuveitis Uveitis, Intermediate | Drug: 4 mg CLS-TA Drug: 0.8 mg CLS-TA | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 22 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Masked, Multicenter Study to Assess the Safety and Efficacy of CLS-TA, Triamcinolone Acetonide Injectable Suspension in the Treatment of Subjects With Macular Edema Following Uveitis |
| Study Start Date : | October 2014 |
| Actual Primary Completion Date : | December 2015 |
| Actual Study Completion Date : | January 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 4 mg CLS-TA
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
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Drug: 4 mg CLS-TA
40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) |
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Experimental: 0.8 mg CLS-TA
Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA
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Drug: 0.8 mg CLS-TA
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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255032
| United States, Florida | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60611 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02114 | |
| Waltham, Massachusetts, United States, 02451 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68105 | |
| United States, New York | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, North Dakota | |
| Fargo, North Dakota, United States, 58103 | |
| United States, Ohio | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| Dallas, Texas, United States, 75231 | |
| Study Director: | Thomas Ciulla, MD | Clearside Biomedical, Inc. |
| Responsible Party: | Clearside Biomedical, Inc. |
| ClinicalTrials.gov Identifier: | NCT02255032 |
| Other Study ID Numbers: |
CLS1001-201 |
| First Posted: | October 2, 2014 Key Record Dates |
| Results First Posted: | February 8, 2021 |
| Last Update Posted: | February 8, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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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 |
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Macular Edema Uveitis Panuveitis Uveitis, Posterior Uveitis, Intermediate Pars Planitis Uveitis, Anterior Edema |
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Uveal Diseases Choroiditis Choroid Diseases |