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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier:
NCT02303184
First received: November 25, 2014
Last updated: March 2, 2016
Last verified: March 2016
  Purpose
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 Intervention Phase
Macular Edema
Retinal Vein Occlusion
Drug: suprachoroidal CLS-TA + IVT aflibercept
Drug: suprachoroidal sham + IVT aflibercept
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Clearside Biomedical, Inc.:

Primary Outcome Measures:
  • Total number of times a subject qualifies to be administered IVT aflibercept in each arm [ Time Frame: 3 months ]

Enrollment: 46
Study Start Date: January 2015
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: suprachoroidal CLS-TA + IVT aflibercept
suprachoroidal injection of CLS-TA following a 2 mg intravitreal injection of aflibercept
Other Name: Active Arm
Active Comparator: suprachoroidal sham + IVT aflibercept
Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept
Drug: suprachoroidal sham + IVT aflibercept
suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept
Other Name: Control Arm

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02303184

Locations
United States, Arizona
Phoenix, Arizona, United States
United States, California
Beverly Hills, California, United States
San Diego, California, United States
United States, Florida
Boynton Beach, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Missouri
St. Louis, Missouri, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, South Dakota
Rapid City, South Dakota, United States
United States, Texas
Abilene, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
Sponsors and Collaborators
Clearside Biomedical, Inc.
Investigators
Study Director: Glenn Noronha, PhD Clearside Biomedical, Inc.
  More Information

Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02303184     History of Changes
Other Study ID Numbers: CLS1003-201
Study First Received: November 25, 2014
Last Updated: March 2, 2016

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:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Polystyrene sulfonic acid
Triamcinolone Acetonide
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 28, 2017