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

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. Identifier: NCT02980874
Recruitment Status : Terminated (Primary, 8-week efficacy endpoint not achieved. No additional benefit for subjects receiving a corticosteroid together with an intravitreal anti-VEGF agent.)
First Posted : December 2, 2016
Last Update Posted : December 20, 2019
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 Drug: suprachoroidal sham Drug: 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

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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 31, 2017
Actual Primary Completion Date : December 10, 2018
Actual Study Completion Date : December 10, 2018

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
suprachoroidal injection of CLS-TA

Drug: IVT aflibercept
2 mg intravitreal injection of aflibercept

Active Comparator: Control
IVT aflibercept (2 mg/0.05 mL) + sham SC procedure
Drug: suprachoroidal sham
suprachoroidal sham procedure

Drug: IVT aflibercept
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

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT02980874

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Sponsors and Collaborators
Clearside Biomedical, Inc.
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Study Director: Thomas Ciulla, MD Clearside Biomedical, Inc.
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Responsible Party: Clearside Biomedical, Inc. Identifier: NCT02980874    
Other Study ID Numbers: CLS1003-301
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019

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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.:
Central Subfield Thickness
Optical Coherence Tomography
Cystoid Macular Edema
Subretinal Fluid
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases