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Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO (TOPAZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03203447
Recruitment Status : Terminated (The early termination is due to the results obtained from the sister study, SAPPHIRE (CLS1003-301), which did not meet the 8-week primary efficacy endpoint.)
First Posted : June 29, 2017
Results First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Clearside Biomedical, Inc.

Study Description
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Brief Summary:
This Phase 3, multicenter, randomized, masked, controlled, parallel group study is designed to demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT) anti-VEGF agent in subjects with treatment naive RVO is superior to IVT anti-VEGF agent used alone.

Condition or disease Intervention/treatment Phase
Macular Edema Retinal Vein Occlusion Drug: suprachoroidal CLS-TA Drug: suprachoroidal sham Drug: Lucentis or Avastin Phase 3

Detailed Description:
A Randomized, Masked, Controlled Trial to Study the Safety and Efficacy of Suprachoroidal CLS-TA With Intravitreal Anti-VEGF Agent in Subjects With Retinal Vein Occlusion
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Combination With An Intravitreal Anti-VEGF Agent In Subjects With Retinal Vein Occlusion
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : December 18, 2018
Actual Study Completion Date : December 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active
Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection
 Drug: suprachoroidal CLS-TA
suprachoroidal injection of CLS-TA
Other Name: Triamcinolone acetonide

Drug: Lucentis or Avastin
IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
Other Name: IVT anti-VEGF agent
Sham Comparator: Control
Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure
 Drug: suprachoroidal sham
sham suprachoroidal procedure

Drug: Lucentis or Avastin
IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
Other Name: IVT anti-VEGF agent


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) [ Time Frame: 2 months ]
    Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.


Secondary Outcome Measures :
  1. Mean Change From Baseline in Best Corrected Visual Acuity [ Time Frame: 6 months ]
    Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.

  2. Mean Change From Baseline in Central Subfield Thickness [ Time Frame: 6 months ]
    Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Has a clinical diagnosis of RVO in the study eye
  • Has a CST of ≥ 300 µm in the study eye
  • Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye
  • Is naïve to local pharmacologic treatment for RVO in the study eye

Exclusion Criteria:

  • Any active ocular disease or infection in the study eye other than RVO
  • History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring more than one medication
  • Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
  • Any evidence of neovascularization in the study eye
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203447


Locations
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Sponsors and Collaborators
Clearside Biomedical, Inc.
Investigators
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Study Director: Thomas Ciulla, MD Chief Medical Officer
  Study Documents (Full-Text)

Documents provided by Clearside Biomedical, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] January 25, 2018

More Information
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Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT03203447    
Other Study ID Numbers: CLS1003-302
First Posted: June 29, 2017    Key Record Dates
Results First Posted: April 23, 2021
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clearside Biomedical, Inc.:
RVO
ME
Microneedle
Microinjection
Triamcinolone
Choroid
Choroid injection
Suprachoroidal
Anti-VEGF
Subretinal Fluid
 Cystoid Macular Edema
Optical Coherence Tomography
OCT
Central Subfield Thickness
Lucentis
Avastin
Ranibizumab
Bevacizumab
Triamcinolone acetonide
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
 Bevacizumab
Ranibizumab
Triamcinolone diacetate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents