Study Stopped
Primary, 8-week efficacy endpoint not achieved. No additional benefit for subjects receiving a corticosteroid together with an intravitreal anti-VEGF agent.
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
SAPPHIRE
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
1 other identifier
interventional
460
15 countries
104
Brief Summary
This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2017
104 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2016
CompletedFirst Posted
Study publicly available on registry
December 2, 2016
CompletedStudy Start
First participant enrolled
January 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2018
CompletedResults Posted
Study results publicly available
April 14, 2021
CompletedApril 14, 2021
March 1, 2021
1.9 years
November 30, 2016
March 18, 2021
March 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
2 months
Secondary Outcomes (2)
Mean Change From Baseline in Best Corrected Visual Acuity
6 months
Mean Change From Baseline in Central Subfield Thickness
6 months
Study Arms (2)
Active
EXPERIMENTALIVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections
Control
ACTIVE COMPARATORIVT aflibercept (2 mg/0.05 mL) + sham SC procedure
Interventions
suprachoroidal injection of CLS-TA
2 mg intravitreal injection of aflibercept
Eligibility Criteria
You may qualify if:
- 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (110)
Associated Retina Consultants, Ltd.
Peoria, Arizona, 85381, United States
Retinal Consultants of Arizona and Retinal Research Institute
Phoenix, Arizona, 85014-2709, United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, 85021, United States
Associated Retina Consultants, Ltd.
Phoenix, Arizona, 85381, United States
Retina Centers P.C.
Tucson, Arizona, 85704, United States
California Retina Research Consultants
Bakersfield, California, 93309, United States
Retina Vitreous Medical Group Clinical Research
Beverly Hills, California, 90211-1841, United States
Atlantis Eyecare
Huntington Beach, California, 92647, United States
Jacobs Retina Center at the Shiley Eye Institute, UCSD
La Jolla, California, 92093, United States
Northern California Retina Vitreous Associates
Mountain View, California, 94040, United States
East Bay Retina Consultants Inc.
Oakland, California, 95409, United States
Southern California Desert Retina Consultants
Palm Desert, California, 92211, United States
Retina Institute of California
Palm Desert, California, 92260, United States
Retina Consultants San Diego
Poway, California, 92064-2526, United States
Orange County Retina Medical Group
Santa Ana, California, 92705, United States
California Retina Consultants CRC
Santa Barbara, California, 93103, United States
Bay Area Retina Associates
Walnut Creek, California, 94599, United States
Colorado Retina Associates
Golden, Colorado, 80401, United States
New England Retina Associates
Hamden, Connecticut, 06518, United States
MedEye Associates
Miami, Florida, 33143-5188, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Sarasota Retina Institute
Sarasota, Florida, 34239, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, United States
Emory Eye Center
Atlanta, Georgia, 30322, United States
Southeast Retina Center, PC
Augusta, Georgia, 30909, United States
Marietta Eye Clinic
Marietta, Georgia, 30060, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701, United States
Illinois Eye and Ear Infirmary, UIC
Chicago, Illinois, 60612, United States
Illinois Retina Associates
Chicago, Illinois, 60657, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Midwest Eye Institute
Indianapolis, Indiana, 46290, United States
Retina Associates, PA
Shawnee Mission, Kansas, 66204, United States
Retina and Vitrous Associates of Kentucky
Lexington, Kentucky, 40509, United States
Wilmer Eye Institute John Hopkins University
Baltimore, Maryland, 21287-0005, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740-5940, United States
The Retina Institute
St Louis, Missouri, 63128, United States
Retina Associates of NJ
Teaneck, New Jersey, 07666, United States
Western Carolina Retinal Associates, PA
Asheville, North Carolina, 28803, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Cleveland Clinic Foundation/Cole Eye Institute
Cleveland, Ohio, 44195, United States
Oregon Retina Institute
Medford, Oregon, 97504, United States
Casey Eye Institute/Oregon Health & Science University
Portland, Oregon, 97239, United States
Eye Care Specialists
Kingston, Pennsylvania, 18704, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701-7374, United States
Retina Research Institute of Texas
Abilene, Texas, 79606-1224, United States
Texas Retina Associates-Arlington
Arlington, Texas, 76012-2505, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Retina Consultants of Houston
Houston, Texas, 77030, United States
Valley Retina Institute
McAllen, Texas, 78503, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240-1502, United States
Retina Consultants of Houston
The Woodlands, Texas, 77384, United States
University of Utah HSC - John A. Moran Eye Center
Salt Lake City, Utah, 84132, United States
Retina Institute of Virginia
Richmond, Virginia, 23235, United States
Virginia Retina Center
Warrenton, Virginia, 20186, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53705, United States
Strathfield Retina Clinic
Strathfield, New South Wales, 2135, Australia
Save Site Institute, University of Sydney, Sydney Eye Hospital
Sydney, New South Wales, 2000, Australia
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, 2000, Australia
Marsden Eye Specialists
Sydney, New South Wales, 2150, Australia
The Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, 3002, Australia
Specialist Eye Group
Melbourne, Victoria, 3150, Australia
University of Graz-Department of Ophthalmology
Graz, Austria
Kepler University Hospital
Linz, Austria
UBC/VGH Eye Care Centre
Vancouver, British Columbia, V5Z 3N9, Canada
St. Joseph's Health Care London, Ivey Eye Institute
London, Ontario, N6A 4V2, Canada
University of Ottawa Eye Institute
Ottawa, Ontario, K1H 8L6, Canada
Institut de l'oeil des Laurentides
Boisbriand, Quebec, J7H 1S6, Canada
CIUSSS de l'Est-de-l'Ile-de-Montreal. Hospital Maisonneuve-Rosemont, Comite d'ethique de la recherche
Montreal, Quebec, H1T 2M4, Canada
Rigshospitalet
Glostrup Municipality, Denmark
Dept. of Ophthalmology, Sjællands Universitetshospital, Roskilde
Roskilde, Denmark
Semmelweis Egyetem, Szemeszeti Klinika
Budapest, 1083, Hungary
Bajcsy-Zsilinszky Korhaz es Rendelointezet, Szemeszeti Osztaly
Budapest, 1106, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1162, Hungary
Budapest Retina Associates
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont, Szemklinika
Debrecen, 4032, Hungary
Ganglion Orvosi Kozpont
Pécs, 7621, Hungary
M&J Western Regional Institute of Ophthalmology
Ahmedabad, Gujarat, 380016, India
T.N. Medical College and B.Y.L. Nair Charitable Hospital
Mumbai, Maharashtra, 400008, India
Department of Medical Ophthalmology, Retina & Uvea
Delhi, New Delhi, 110029, India
Aravind Eye Hospitals & Postgraduate Institute of Ophthalmology
Madurai, Tamil Nadu, 625020, India
Smt. Kanuri Santhamma Centre for Vitreo Retinal Diseases
Hyderabad, Telangana, 500034, India
Disha Eye Hospital Private Limited
Kolkata, West Bengal, 700120, India
Bnai Zion Medical Center
Haifa, 3104802, Israel
ASST Fatebenefratelli Sacco - P.O.L., University of Milan, Dep. of Ophthalmology
Milan, 20157, Italy
Cebu Doctor's University Hospital
Cebu City, 6000, Philippines
Peregrine Eye & Laser Institute
Makati City, 1209, Philippines
The Medical City
Pasig, 1600, Philippines
Oftalmika sp. z o. o.
Bydgoszcz, 85-631, Poland
Optimum Profesorskie Centrum Okulistyki
Gdansk, 80-809, Poland
Uniwersytet Medyczny w Lublinie
Lublin, 20-079, Poland
Centrum Diagnostyki i Mikrochirurgii Oka Lens
Olsztyn, 10-424, Poland
Centro Clinico Academico Braga - 2CA-Braga
Braga, 4710-243, Portugal
Centro Hospitalar e Universitario de Coimbra, E.P.E.
Coimbra, 3000-075, Portugal
Centro Hospitalar de Sao Joao, E.P.E.
Porto, 4200-319, Portugal
Fakultna nemocnica s poliklinikou Zilina
Žilina, 01207, Slovakia
Instituto Cinico Quirurgico de Oftalmologia
Bilbao, Vizcaya, 48006, Spain
Hospital General de Catalunya
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Instituto Oftalmologico Fernandez-Vega
Oviedo, 33012, Spain
Clinica Universidad de Navarra
Pamplona, 31008, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Hospital Clinico Universitario
Zaragoza, Spain
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Queens University Royal Victoria Hospital Trust
Belfast, BT12 6BJ, United Kingdom
Sunderland Eye Infirmary
Sunderland, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to the early termination of the trial by sponsor all planned study visits were not completed by all treated subjects; therefore, all planned data was not collected.
Results Point of Contact
- Title
- Thomas Ciulla, MD MBA
- Organization
- Clearside Biomedical, Inc.
Study Officials
- STUDY DIRECTOR
Thomas Ciulla, MD MBA
Clearside Biomedical, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2016
First Posted
December 2, 2016
Study Start
January 31, 2017
Primary Completion
December 10, 2018
Study Completion
December 10, 2018
Last Updated
April 14, 2021
Results First Posted
April 14, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share