Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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

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

Details

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

Keywords

Macular Edema Retinal Vein Occlusion RVO ME Central Subfield Thickness OCT Optical Coherence Tomography Cystoid Macular Edema Subretinal Fluid Eylea Aflibercept Anti-VEGF Suprachoroidal Edema Triamcinolone Acetonide suprachoroidal CLS-TA + IVT aflibercept suprachoroidal sham + IVT aflibercept

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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;

You CAN'T join if...

  • 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

Locations

  • Jacobs Retina Center at the Shiley Eye Institute, UCSD accepting new patients
    La Jolla, California, 92093, United States
  • Retina Consultants San Diego accepting new patients
    Poway, California, 92064-2526, United States
  • Orange County Retina Medical Group accepting new patients
    Santa Ana, California, 92705, United States
  • Atlantis Eyecare accepting new patients
    Huntington Beach, California, 92647, United States
  • Retina Institute of California accepting new patients
    Palm Desert, California, 92260, United States
  • Southern California Desert Retina Consultants accepting new patients
    Palm Desert, California, 92211, United States
  • Retina Vitreous Medical Group Clinical Research accepting new patients
    Beverly Hills, California, 90211-1841, United States
  • California Retina Consultants CRC accepting new patients
    Santa Barbara, California, 93103, United States
  • California Retina Research Consultants accepting new patients
    Bakersfield, California, 93309, United States
  • Associated Retina Consultants, Ltd. accepting new patients
    Peoria, Arizona, 85381, United States
  • Associated Retina Consultants, Ltd. accepting new patients
    Phoenix, Arizona, 85381, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Clearside Biomedical, Inc.
ID
NCT02980874
Phase
Phase 3
Study Type
Interventional
Last Updated
May 8, 2018