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

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ClinicalTrials.gov Identifier: NCT02980874
Recruitment Status : Active, not recruiting
First Posted : December 2, 2016
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Clearside Biomedical, Inc.

Brief Summary:
This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.

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

Detailed Description:
A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal veinocclusion

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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




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 ]
    Based on best corrected visual acuity


Secondary Outcome Measures :
  1. Mean change from baseline in best corrected visual acuity [ Time Frame: 6 months ]
    Based on ETDRS

  2. Mean change from baseline in central subfield thickness [ Time Frame: 6 months ]
    Based on spectral domain optical coherence tomography



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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

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): NCT02980874


  Show 110 Study Locations
Sponsors and Collaborators
Clearside Biomedical, Inc.
Investigators
Study Director: Jennifer Kissner, PhD Clearside Biomedical, Inc.

Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02980874     History of Changes
Other Study ID Numbers: CLS1003-301
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

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
Central Subfield Thickness
OCT
Optical Coherence Tomography
Cystoid Macular Edema
Subretinal Fluid
Eylea
Aflibercept
Anti-VEGF
Suprachoroidal

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
Triamcinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors