this is a phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004648-12-AT

Enrollment

460

Registered

2017-05-24

Start date

2017-07-09

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Vein Occlusion

Interventions

Product Name: Triamcinolone acetonide Product Code: CLS-TA Pharmaceutical Form: Suspension for injection INN or Proposed INN: Triamcinolone acetonide

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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 ; 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 ;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).;Timepoint(s) of evaluation of this end point: during treatment period	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
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) ;Timepoint(s) of evaluation of this end point: during treatment period	—

Countries

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

Contacts

Public ContactKathleen Billman

Clearside Biomedical, Inc

Kathleen.Billman@clearsidebio.com001678894-0703

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026