Macular EdemaPhase 2TANZANITENCT02303184
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
A Phase 2 study testing 4 mg CLS-TA and IVT aflibercept in people with Macular Edema and Retinal Vein Occlusion, run by Clearside Biomedical, Inc. at 14 sites in United States.
Trial summary
A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Retinal Vein Occlusion
- What is being tested?
- 4 mg CLS-TA and IVT aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 14 sitesUnited States
- Study dates
- Jan 2015to Mar 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 macular edema following RVO
- History of ME ≤ 12 months
- 20-70 letters inclusive BCVA using ETDRS
Who cannot join
- has had an IVT injection of anti-VEGF for RVO in the study eye
- has had a corticosteroid injection in the past 3 months in the study eye
- any uncontrolled ophthalmic condition in the study eye other than RVO
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Study site
Abilene, Texas, 79606
Study site
Atlanta, Georgia, 30322
Study site
Baltimore, Maryland, 21287
Study site
Beverly Hills, California, 90211
Study site
Boynton Beach, Florida, 33426
Study site
Houston, Texas, 77030
Study site
McAllen, Texas, 78503
Study site
Phoenix, Arizona, 85014
Study site
Rapid City, South Dakota, 57701
Study site
San Antonio, Texas, 78251
Study site
San Diego, California, 92037
Study site
St Louis, Missouri, 63128
Study site
The Woodlands, Texas, 77384
Study site
Winston-Salem, North Carolina, 27157
About this study
Official title: TANZANITE: Safety and Efficacy of Suprachoroidal CLS-TA in Combination With Intravitreal Aflibercept in Subjects With Macular Edema Following Retinal Vein Occlusion
A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO).
Read the detailed description
A randomized, masked, controlled trial of safety and efficacy of suprachoroidal CLS-TA in combination with intravitreal aflibercept in subjects with macular edema following retinal vein occlusion
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Being tested
- 4 mg CLS-TA, Sham, IVT aflibercept
- Keywords
- RVO, ME, Central Subfield Thickness, OCT, optical coherence tomography, cystoid macular edema, subretinal fluid, Eylea, aflibercept, anti-VEGF
- Medical subject headings
- Macular Edema, Retinal Vein Occlusion
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)
ShamDrug
Also called suprachoroidal sham
suprachoroidal sham procedure
IVT afliberceptDrug
Also called Eylea
2 mg intravitreal injection of aflibercept
| Study group | Role | What they receive |
|---|---|---|
| 4 mg CLS-TA + IVT aflibercept | Experimental | Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept Receives: Drug: 4 mg CLS-TA; Drug: IVT aflibercept |
| sham + IVT aflibercept | Active comparator | Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept Receives: Drug: Sham; Drug: IVT aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionMar 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 Macular EdemaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 46 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
- NCT02303184
- Sponsor's protocol ID
- CLS1003-201
- Acronym
- TANZANITE
- Status last verified
- Jan 2021
- First submitted
- 25 Nov 2014
- Last updated
- 8 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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
- TANZANITE: Safety and Efficacy of Suprachoroidal CLS-TA in Combination With Intravitreal Aflibercept in Subjects With Macular Edema Following Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT02303184
- Acronym / sponsor ID
- TANZANITE / CLS1003-201
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Keywords
- RVO, ME, Central Subfield Thickness, OCT, optical coherence tomography, cystoid macular edema, subretinal fluid, Eylea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Clearside Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Nov 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.
A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO).
Detailed description
A randomized, masked, controlled trial of safety and efficacy of suprachoroidal CLS-TA in combination with intravitreal aflibercept in subjects with macular edema following retinal vein occlusion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 mg CLS-TA + IVT aflibercept | Experimental | Drug: 4 mg CLS-TA, Drug: IVT afliberceptSingle unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept |
| sham + IVT aflibercept | Active comparator | Drug: Sham, Drug: IVT afliberceptSingle unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of macular edema following RVO
- History of ME ≤ 12 months
- 20-70 letters inclusive BCVA using ETDRS
Key exclusion criteria (3 listed)
- has had an IVT injection of anti-VEGF for RVO in the study eye
- has had a corticosteroid injection in the past 3 months in the study eye
- any uncontrolled ophthalmic condition in the study eye other than RVO
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 + IVT aflibercept |
| ShamAlso: suprachoroidal shamsuprachoroidal sham procedure | Drug | sham + IVT aflibercept |
| IVT afliberceptAlso: Eylea2 mg intravitreal injection of aflibercept | Drug | 4 mg CLS-TA + IVT aflibercept, sham + IVT aflibercept |
Primary outcome
Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm
Time frame: 3 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.
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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.
14 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 IVT aflibercept in people with Macular Edema and Retinal Vein Occlusion, run by Clearside Biomedical, Inc. at 14 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 3 inclusion and 3 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 14 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?
Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm (time frame: 3 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.