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

• Sponsor: Clearside Biomedical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02303184
• Collaborator: (none)
• Enrollment: 46
• Locations: 14
• Arms: 2
• Duration (Months): 14
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Macular Edema; Retinal Vein Occlusion	Drug: 4 mg CLS-TA; Drug: Sham; Drug: IVT aflibercept	Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: TANZANITE: Safety and Efficacy of Suprachoroidal CLS-TA in Combination With Intravitreal Aflibercept in Subjects With Macular Edema Following Retinal Vein Occlusion
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 4 mg 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	Drug: 4 mg CLS-TA; 40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension); Drug: IVT aflibercept; 2 mg intravitreal injection of aflibercept; Other Names: Eylea
Active Comparator: sham + IVT aflibercept Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept	Drug: Sham; suprachoroidal sham procedure; Other Names: suprachoroidal sham ; Drug: IVT aflibercept; 2 mg intravitreal injection of aflibercept; Other Names: Eylea

Outcome Measures

Primary Outcome Measures

1. Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States	85014
2		Beverly Hills	California	United States	90211
3		San Diego	California	United States	92037
4		Boynton Beach	Florida	United States	33426
5		Atlanta	Georgia	United States	30322
6		Baltimore	Maryland	United States	21287
7		Saint Louis	Missouri	United States	63128
8		Winston-Salem	North Carolina	United States	27157
9		Rapid City	South Dakota	United States	57701
10		Abilene	Texas	United States	79606
11		Houston	Texas	United States	77030
12		McAllen	Texas	United States	78503
13		San Antonio	Texas	United States	78251
14		The Woodlands	Texas	United States	77384

Sponsors and Collaborators

• Clearside Biomedical, Inc.

Investigators

• Study Director: Thomas Ciulla, MD, Clearside Biomedical, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clearside Biomedical, Inc.
• ClinicalTrials.gov Identifier: NCT02303184
• Other Study ID Numbers: CLS1003-201
• First Posted: Nov 27, 2014
• Last Update Posted: Feb 8, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Clearside Biomedical, Inc.: RVO; ME; Central Subfield Thickness; OCT; optical coherence tomography; cystoid macular edema; subretinal fluid; Eylea; aflibercept; anti-VEGF
• Additional relevant MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema; Aflibercept

Study Results

Participant Flow

Arm/Group Title	Suprachoroidal CLS-TA + IVT Aflibercept	Suprachoroidal Sham + IVT Aflibercept
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	23	23
COMPLETED	23	23
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Suprachoroidal CLS-TA + IVT Aflibercept	Suprachoroidal Sham + IVT Aflibercept	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	23	23	46
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 21.7%	10 43.5%	15 32.6%
>=65 years	18 78.3%	13 56.5%	31 67.4%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	66.9 (12.02)	65.8 (14.64)	66.3 (12.02)
Sex: Female, Male (Count of Participants)
Female	10 43.5%	13 56.5%	23 50%
Male	13 56.5%	10 43.5%	23 50%
Region of Enrollment (participants) [Number]
United States	23 100%	23 100%	46 100%

Outcome Measures

1. Primary Outcome

Title	Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Suprachoroidal CLS-TA + IVT Aflibercept	Suprachoroidal Sham + IVT Aflibercept
Arm/Group Description	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	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
Measure Participants	23	23
0	18 78.3%	7 30.4%
1	3 13%	12 52.2%
2	0 0%	1 4.3%
3	2 8.7%	3 13%

Adverse Events

Time Frame	3 months
Arm/Group Title	Suprachoroidal CLS-TA + IVT Aflibercept		Suprachoroidal Sham + IVT Aflibercept
Arm/Group Description	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		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
All Cause Mortality
	Suprachoroidal CLS-TA + IVT Aflibercept		Suprachoroidal Sham + IVT Aflibercept
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Serious Adverse Events
	Suprachoroidal CLS-TA + IVT Aflibercept		Suprachoroidal Sham + IVT Aflibercept
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Suprachoroidal CLS-TA + IVT Aflibercept		Suprachoroidal Sham + IVT Aflibercept
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/23 (52.2%)		10/23 (43.5%)
Ear and labyrinth disorders
Vertigo	1/23 (4.3%)	1	0/23 (0%)	0
Eye disorders
Cataract	1/23 (4.3%)	1	0/23 (0%)	0
Cataract	0/23 (0%)	0	1/23 (4.3%)	1
Conjunctival haemorrhage	2/23 (8.7%)	2	1/23 (4.3%)	1
Conjunctival hyperaemia	2/23 (8.7%)	2	0/23 (0%)	0
Conjunctivitis allergic	0/23 (0%)	0	1/23 (4.3%)	1
Conjunctivitis allergic	0/23 (0%)	0	1/23 (4.3%)	1
Corneal oedema	1/23 (4.3%)	1	0/23 (0%)	0
Eye pain	8/23 (34.8%)	9	1/23 (4.3%)	1
Foreign body sensation in eyes	1/23 (4.3%)	1	0/23 (0%)	0
Lacrimation increased	1/23 (4.3%)	1	0/23 (0%)	0
Macular fibrosis	0/23 (0%)	0	1/23 (4.3%)	1
Ocular discomfort	0/23 (0%)	0	2/23 (8.7%)	2
Ocular hypertension	2/23 (8.7%)	2	0/23 (0%)	0
Optic disc vascular disorder	0/23 (0%)	0	1/23 (4.3%)	1
Optic nerve disorder	1/23 (4.3%)	1	0/23 (0%)	0
Punctate keratitis	1/23 (4.3%)	1	0/23 (0%)	0
Retinal degeneration	0/23 (0%)	0	1/23 (4.3%)	1
Retinal degeneration	0/23 (0%)	0	1/23 (4.3%)	1
Retinal exudates	1/23 (4.3%)	1	1/23 (4.3%)	1
Retinal haemorrhage	1/23 (4.3%)	2	0/23 (0%)	0
Retinopathy	0/23 (0%)	0	1/23 (4.3%)	1
Vision blurred	0/23 (0%)	0	1/23 (4.3%)	1
Vision blurred	0/23 (0%)	0	1/23 (4.3%)	1
Visual acuity reduced	0/23 (0%)	0	2/23 (8.7%)	2
Vitreous detachment	1/23 (4.3%)	1	0/23 (0%)	0
Vitreous floaters	1/23 (4.3%)	1	0/23 (0%)	0
Gastrointestinal disorders
Nausea	1/23 (4.3%)	1	0/23 (0%)	0
Investigations
Intraocular pressure increased	2/23 (8.7%)	2	0/23 (0%)	0
Metabolism and nutrition disorders
Hypercholesterolaemia	0/23 (0%)	0	1/23 (4.3%)	1
Nervous system disorders
Headache	2/23 (8.7%)	2	1/23 (4.3%)	1
Psychiatric disorders
Anxiety	1/23 (4.3%)	1	0/23 (0%)	0
Vascular disorders
Hypertension	4/23 (17.4%)	4	1/23 (4.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The institution and investigators participating in this trial shall have no right to publish or present the results of this study without the prior written consent of Clearside.