UveitisPhase 2DOGWOODNCT02255032
Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis
A Phase 2 study testing 4 mg CLS-TA and 0.8 mg CLS-TA in people with Uveitis and Macular Edema, run by Clearside Biomedical, Inc. at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Macular Edema, Uveitis, Posterior
- What is being tested?
- 4 mg CLS-TA and 0.8 mg CLS-TA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 11 sitesUnited States
- Study dates
- Oct 2014to Jan 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of noninfectious uveitis
- diagnosis of macular edema associated with noninfectious uveitis
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Atlanta, Georgia, 30322
Study site
Boston, Massachusetts, 02114
Study site
Chicago, Illinois, 60611
Study site
Cleveland, Ohio, 44195
Study site
Dallas, Texas, 75231
Study site
Fargo, North Dakota, 58103
Study site
Miami, Florida, 33136
Study site
New York, New York, 10021
Study site
Omaha, Nebraska, 68105
Study site
Waltham, Massachusetts, 02451
Study site
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read the 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.
- Conditions
- Uveitis, Macular Edema, Uveitis, Posterior, Uveitis, Anterior, Panuveitis, Uveitis, Intermediate
- Being tested
- 4 mg CLS-TA, 0.8 mg CLS-TA
- 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
- Medical subject headings
- Uveitis, Macular Edema, Uveitis, Posterior, Uveitis, Anterior, Panuveitis, Uveitis, Intermediate, Choroidal Effusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 mg CLS-TADrug
40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
0.8 mg CLS-TADrug
8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
| Study group | Role | What they receive |
|---|---|---|
| 4 mg CLS-TA | Experimental | Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA Receives: Drug: 4 mg CLS-TA |
| 0.8 mg CLS-TA | Experimental | Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA Receives: Drug: 0.8 mg CLS-TA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clearside Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Ciulla, MD, Study director, Clearside Biomedical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255032
- Sponsor's protocol ID
- CLS1001-201
- Acronym
- DOGWOOD
- Status last verified
- Jan 2021
- First submitted
- 30 Sep 2014
- Last updated
- 8 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02255032
- Acronym / sponsor ID
- DOGWOOD / CLS1001-201
- Conditions
- Uveitis, Macular Edema, Uveitis, Posterior, Uveitis, Anterior, Panuveitis, Uveitis, Intermediate
- Keywords
- uveitis, macular edema, UME, posterior uveitis, anterior uveitis, panuveitis, intermediate uveitis, noninfectious uveitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Clearside Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Posted 8 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 mg CLS-TA | Experimental | Drug: 4 mg CLS-TASingle unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA |
| 0.8 mg CLS-TA | Experimental | Drug: 0.8 mg CLS-TASingle unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of noninfectious uveitis
- diagnosis of macular edema associated with noninfectious uveitis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4 mg CLS-TA40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) | Drug | 4 mg CLS-TA |
| 0.8 mg CLS-TA8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) | Drug | 0.8 mg CLS-TA |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Ciulla, MD study director
Clearside Biomedical, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 4 mg CLS-TA and 0.8 mg CLS-TA in people with Uveitis and Macular Edema, run by Clearside Biomedical, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.