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Trial record 7 of 9 for:    CARDIOVASCULAR SAPPHIRE

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2016 by Clearside Biomedical, Inc.
Sponsor:
Information provided by (Responsible Party):
Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier:
NCT02980874
First received: November 30, 2016
Last updated: NA
Last verified: November 2016
History: No changes posted
  Purpose
This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.

Condition Intervention Phase
Macular Edema
Retinal Vein Occlusion
Drug: suprachoroidal CLS-TA + IVT aflibercept
Drug: suprachoroidal sham + IVT aflibercept
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SAPPHIRE: A RANDOMIZED, MASKED, CONTROLLED TRIAL TO STUDY THE SAFETY AND EFFICACY OF SUPRACHOROIDAL CLS-TA IN CONJUNCTION WITH INTRAVITREAL AFLIBERCEPT IN SUBJECTS WITH RETINAL VEIN OCCLUSION

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of subjects demonstrating ≥ 15 letter improvement from Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Based on best corrected visual acuity


Secondary Outcome Measures:
  • Mean change from baseline in best corrected visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Based on ETDRS

  • Mean change from baseline in central subfield thickness [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Based on spectral domain optical coherence tomography


Estimated Enrollment: 460
Study Start Date: January 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections
Drug: suprachoroidal CLS-TA + IVT aflibercept
suprachoroidal injection of CLS-TA following a 2 mg intravitreal injection of aflibercept
Active Comparator: Control
IVT aflibercept (2 mg/0.05 mL) + sham SC procedure
Drug: suprachoroidal sham + IVT aflibercept
suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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 ≥ 5 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
  • Intraocular pressure > 22mmHg or uncontrolled glaucoma in study eye
  • 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
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: NCT02980874

Contacts
Contact: Kathleen Billman kathleen.billman@clearsidebio.com
Contact: Nichole Wilkes nichole.wilkes@clearsidebio.com

Sponsors and Collaborators
Clearside Biomedical, Inc.
Investigators
Study Director: Jennifer Kissner, PhD Clearside Biomedical, Inc.
  More Information

Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02980874     History of Changes
Other Study ID Numbers: CLS1003-301 
Study First Received: November 30, 2016
Last Updated: November 30, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Clearside Biomedical, Inc.:
RVO
ME
Central Subfield Thickness
OCT
Optical Coherence Tomography
Cystoid Macular Edema
Subretinal Fluid
Eylea
Aflibercept
Anti-VEGF
Suprachoroidal

Additional relevant MeSH terms:
Cardiovascular Diseases
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
Triamcinolone Acetonide
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 December 09, 2016