Retinal Vein Occlusion
Conditions
Interventions
Product Name: Triamcinoclone acetonide
Product Code: CLS-TA
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: TRIAMCINOLONE ACETONIDE
Current Sponsor code: CLS-TA
Concentration unit:
Sponsors
Clearside Biomedical, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has a clinical diagnosis of RVO in the study eye within = 6 months screening; 2. Has a CST of = 300 µm in the study eye as measured by spectral-domain optical coherence tomography (SD-OCT) with intraretinal or subretinal fluid and confirmed by the central reading center (CRC); 3. Has an ETDRS BCVA score of = 20 letters read and = 70 letters read in the study eye; at least 20 letters in the non-study eye; 4. Is naïve to local pharmacologic treatment for RVO in the study eye; 5. Is at least 18 years of age, understands the language of the informed consent and is willing and able to provide written informed consent before any study procedures, and is willing to comply with the instructions and attend all scheduled study visits. 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) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: * macular edema with etiology 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: To demonstrate that suprachoroidally injected CLS-TA in combination with an intravitreally injected anti-VEGF agent is superior to an intravitreally injected anti-VEGF agent alone using a best corrected visual acuity (BCVA) outcome measure. ;Secondary Objective: • To determine the effect of suprachoroidally injected CLS-TA in combination with an intravitreally injected anti-VEGF agent on mean change from Baseline in BCVA • To determine the effect of suprachoroidally injected CLS-TA in combination with an intravitreally injected anti-VEGF agent on mean change from Baseline in central subfield thickness ;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, Czech Republic, Estonia, France, Germany, Hungary, India, Latvia, Lithuania, New Zealand, Slovakia, United Kingdom, United States
Contacts
Public ContactKathleen Billman
Clearside Biomedical, Inc.
Outcome results
None listed