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 - SAPPHIRE

• Register: EUCTR
• Last refreshed on: 21 December 2021
• Main ID: EUCTR2016-004648-12-HU
• Date of registration: 03/05/2017
• Prospective Registration: Yes
• Primary sponsor: Clearside Biomedical, Inc.
• Public 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 - SAPPHIRE
• Scientific 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 - SAPPHIRE
• Date of first enrolment: 15/06/2017
• Target sample size: 460
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004648-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Canada, Czech Republic, Denmark, Germany, Hungary, Israel, Italy, Korea, Republic of, Philippines, Poland, Portugal, Slovakia, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Kathleen Billman
• Affiliation: Clearside Biomedical, Inc

• Name: Kathleen Billman
• Affiliation: Clearside Biomedical, Inc

Key inclusion & exclusion 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;
•Is at least 18 years of age

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 460
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•Any active ocular disease or infection in the study eye other than RVO
•Intraocular pressure > 21mmHg in study eye at visit 1
• history of glaucoma, optic nerve head change consistent with glaucoma damage; or ocular hypertension in the study eye 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Retinal Vein Occlusion

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Intervention(s)

Product Name: Triamcinolone acetonide
Product Code: CLS-TA
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Triamcinolone acetonide
Current Sponsor code: CLS-TA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Trade Name: Eylea
Product Name: Eylea
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AFLIBERCEPT
CAS Number: 862111-32-8
Other descriptive name: AFLIBERCEPT
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Main Objective: 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

Primary end point(s): proportion of subjects demonstrating = 15 letter improvement from Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) BCVA at Visit 4 (Month 2).

Secondary Objective: - Mean change from baseline in best corrected visual acuity [ Time Frame: 6 months ]
Based on ETDRS

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

Timepoint(s) of evaluation of this end point: during treatment period

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: during treatment period

Secondary end point(s): ·Mean change from Baseline (Visit 2, Day 0) in BCVA at Visit 4 (Week 8) and Visit 8 (Week 24)
·Mean change from Baseline (Visit 2, Day 0) in CST at Visit 4 (Week 8) and Visit 8 (Week 24)

Secondary ID(s)

CLS1003-301

2016-004648-12-GB

Source(s) of Monetary Support

Clearside Biomedical, Inc

Ethics review

Status: Approved
Approval date: 07/06/2017
Contact:

Results

• Results available: Yes
• Date Posted: 05/03/2021
• Date Completed: 18/12/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-004648-12/results