Clinical trial NCT02980874: Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Macular Edema
Retinal Vein Occlusion
Keywords: RVO
ME
Central Subfield Thickness
OCT
Optical Coherence Tomography
Cystoid Macular Edema
Subretinal Fluid
Eylea
Aflibercept
Anti-VEGF
Suprachoroidal
Triamcinolone acetonide
Lead sponsor: Clearside Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-02
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 vein occlusion

Eligibility 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;

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

Primary outcomes:
measure: Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)
timeFrame: 2 months
Secondary outcomes:
measure: Mean Change From Baseline in Best Corrected Visual Acuity
timeFrame: 6 months
measure: Mean Change From Baseline in Central Subfield Thickness
timeFrame: 6 months
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Associated Retina Consultants, Ltd.
state: Arizona
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona and Retinal Research Institute
state: Arizona
city: Phoenix
country: United States
facility: Arizona Retina and Vitreous Consultants
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants, Ltd.
state: Arizona
city: Tucson
country: United States
facility: Retina Centers P.C.
state: Arizona
city: Bakersfield
country: United States
facility: California Retina Research Consultants
state: California
city: Beverly Hills
country: United States
facility: Retina Vitreous Medical Group Clinical Research
state: California
city: Huntington Beach
country: United States
facility: Atlantis Eyecare
state: California
city: La Jolla
country: United States
facility: Jacobs Retina Center at the Shiley Eye Institute, UCSD
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Oakland
country: United States
facility: East Bay Retina Consultants Inc.
state: California
city: Palm Desert
country: United States
facility: Southern California Desert Retina Consultants
state: California
city: Palm Desert
country: United States
facility: Retina Institute of California
state: California
city: Poway
country: United States
facility: Retina Consultants San Diego
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Medical Group
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants CRC
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Golden
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Hamden
country: United States
facility: New England Retina Associates
state: Connecticut
city: Miami
country: United States
facility: MedEye Associates
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Atlanta
country: United States
facility: Emory Eye Center
state: Georgia
city: Augusta
country: United States
facility: Southeast Retina Center, PC
state: Georgia
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
city: Chicago
country: United States
facility: Illinois Eye and Ear Infirmary, UIC
state: Illinois
city: Chicago
country: United States
facility: Illinois Retina Associates
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Shawnee Mission
country: United States
facility: Retina Associates, PA
state: Kansas
city: Lexington
country: United States
facility: Retina and Vitrous Associates of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: Wilmer Eye Institute John Hopkins University
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
city: Teaneck
country: United States
facility: Retina Associates of NJ
state: New Jersey
city: Asheville
country: United States
facility: Western Carolina Retinal Associates, PA
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation/Cole Eye Institute
state: Ohio
city: Medford
country: United States
facility: Oregon Retina Institute
state: Oregon
city: Portland
country: United States
facility: Casey Eye Institute/Oregon Health & Science University
state: Oregon
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates-Arlington
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah HSC - John A. Moran Eye Center
state: Utah
city: Richmond
country: United States
facility: Retina Institute of Virginia
state: Virginia
city: Warrenton
country: United States
facility: Virginia Retina Center
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Strathfield
country: Australia
facility: Strathfield Retina Clinic
state: New South Wales
city: Sydney
country: Australia
facility: Save Site Institute, University of Sydney, Sydney Eye Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Retina Clinic and Day Surgery
state: New South Wales
city: Sydney
country: Australia
facility: Marsden Eye Specialists
state: New South Wales
city: East Melbourne
country: Australia
facility: The Royal Victorian Eye and Ear Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Specialist Eye Group
state: Victoria
city: Graz
country: Austria
facility: University of Graz-Department of Ophthalmology
city: Linz
country: Austria
facility: Kepler University Hospital
city: Vancouver
country: Canada
facility: UBC/VGH Eye Care Centre
state: British Columbia
city: London
country: Canada
facility: St. Joseph's Health Care London, Ivey Eye Institute
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Eye Institute
state: Ontario
city: Boisbriand
country: Canada
facility: Institut de l'oeil des Laurentides
state: Quebec
city: Montréal
country: Canada
facility: CIUSSS de l'Est-de-l'Ile-de-Montreal. Hospital Maisonneuve-Rosemont, Comite d'ethique de la recherche
state: Quebec
city: Glostrup
country: Denmark
facility: Rigshospitalet
city: Roskilde
country: Denmark
facility: Dept. of Ophthalmology, Sjællands Universitetshospital, Roskilde
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, Szemeszeti Klinika
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet, Szemeszeti Osztaly
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Budapest Retina Associates
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont, Szemklinika
city: Pecs
country: Hungary
facility: Ganglion Orvosi Kozpont
city: Ahmedabad
country: India
facility: M&J Western Regional Institute of Ophthalmology
state: Gujarat
city: Mumbai
country: India
facility: T.N. Medical College and B.Y.L. Nair Charitable Hospital
state: Maharashtra
city: Delhi
country: India
facility: Department of Medical Ophthalmology, Retina & Uvea
state: New Delhi
city: Madurai
country: India
facility: Aravind Eye Hospitals & Postgraduate Institute of Ophthalmology
state: Tamil Nadu
city: Hyderabad
country: India
facility: Smt. Kanuri Santhamma Centre for Vitreo Retinal Diseases
state: Telangana
city: Kolkata
country: India
facility: Disha Eye Hospital Private Limited
state: West Bengal
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Milan
country: Italy
facility: ASST Fatebenefratelli Sacco - P.O.L., University of Milan, Dep. of Ophthalmology
city: Cebu City
country: Philippines
facility: Cebu Doctor's University Hospital
city: Makati City
country: Philippines
facility: Peregrine Eye & Laser Institute
city: Pasig City
country: Philippines
facility: The Medical City
city: Bydgoszcz
country: Poland
facility: Oftalmika sp. z o. o.
city: Gdansk
country: Poland
facility: Optimum Profesorskie Centrum Okulistyki
city: Lublin
country: Poland
facility: Uniwersytet Medyczny w Lublinie
city: Olsztyn
country: Poland
facility: Centrum Diagnostyki i Mikrochirurgii Oka Lens
city: Braga
country: Portugal
facility: Centro Clinico Academico Braga - 2CA-Braga
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra, E.P.E.
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao, E.P.E.
city: Žilina
country: Slovakia
facility: Fakultna nemocnica s poliklinikou Zilina
city: Bilbao
country: Spain
facility: Instituto Cinico Quirurgico de Oftalmologia
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital General de Catalunya
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Oviedo
country: Spain
facility: Instituto Oftalmologico Fernandez-Vega
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Belfast
country: United Kingdom
facility: Queens University Royal Victoria Hospital Trust
city: Sunderland
country: United Kingdom
facility: Sunderland Eye Infirmary
Study officials:
affiliation: Clearside Biomedical, Inc.
name: Thomas Ciulla, MD MBA
role: STUDY_DIRECTOR
References: