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Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO

TANZANITE: Safety and Efficacy of Suprachoroidal CLS-TA in Combination With Intravitreal Aflibercept in Subjects With Macular Edema Following Retinal Vein Occlusion

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02303184
Acronym
TANZANITE
Enrollment
46
Registered
2014-11-27
Start date
2015-01-31
Completion date
2016-03-31
Last updated
2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema, Retinal Vein Occlusion

Keywords

RVO, ME, Central Subfield Thickness, OCT, optical coherence tomography, cystoid macular edema, subretinal fluid, Eylea, aflibercept, anti-VEGF

Brief 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 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

Interventions

DRUG4 mg CLS-TA

40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

DRUGSham

suprachoroidal sham procedure

DRUGIVT aflibercept

2 mg intravitreal injection of aflibercept

Sponsors

Clearside Biomedical, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* diagnosis of macular edema following RVO * History of ME ≤ 12 months * 20-70 letters inclusive BCVA using ETDRS

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm3 months

Countries

United States

Participant flow

Participants by arm

ArmCount
Suprachoroidal CLS-TA + IVT Aflibercept
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA IVT aflibercept: 2 mg intravitreal injection of aflibercept
23
Suprachoroidal Sham + IVT Aflibercept
Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept suprachoroidal sham: suprachoroidal sham procedure IVT aflibercept: 2 mg intravitreal injection of aflibercept
23
Total46

Baseline characteristics

CharacteristicSuprachoroidal Sham + IVT AfliberceptSuprachoroidal CLS-TA + IVT AfliberceptTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
13 Participants18 Participants31 Participants
Age, Categorical
Between 18 and 65 years
10 Participants5 Participants15 Participants
Age, Continuous65.8 Years
STANDARD_DEVIATION 14.64
66.9 Years
STANDARD_DEVIATION 12.02
66.3 Years
STANDARD_DEVIATION 12.02
Region of Enrollment
United States
23 participants23 participants46 participants
Sex: Female, Male
Female
13 Participants10 Participants23 Participants
Sex: Female, Male
Male
10 Participants13 Participants23 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 230 / 23
other
Total, other adverse events
12 / 2310 / 23
serious
Total, serious adverse events
0 / 230 / 23

Outcome results

Primary

Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm

Time frame: 3 months

Population: The Intent-to-Treat set included all randomly assigned subjects who were treated and had at least one post-Baseline assessment.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Suprachoroidal CLS-TA + IVT AfliberceptTotal Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm018 Participants
Suprachoroidal CLS-TA + IVT AfliberceptTotal Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm13 Participants
Suprachoroidal CLS-TA + IVT AfliberceptTotal Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm20 Participants
Suprachoroidal CLS-TA + IVT AfliberceptTotal Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm32 Participants
Suprachoroidal Sham + IVT AfliberceptTotal Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm33 Participants
Suprachoroidal Sham + IVT AfliberceptTotal Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm07 Participants
Suprachoroidal Sham + IVT AfliberceptTotal Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm21 Participants
Suprachoroidal Sham + IVT AfliberceptTotal Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm112 Participants

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026