Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO

Macular Edema Clinical Trial

— SAPPHIRE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02980874
• Other study ID #: CLS1003-301
• Status: Terminated
• Phase: Phase 3
• Start date: January 31, 2017
• Est. completion date: December 10, 2018

Study information

• Verified date: March 2021
• Source: Clearside Biomedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 460
• Est. completion date: December 10, 2018
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• suprachoroidal CLS-TA
suprachoroidal injection of CLS-TA
• suprachoroidal sham
suprachoroidal sham procedure
• IVT aflibercept
2 mg intravitreal injection of aflibercept

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Clearside Biomedical, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Denmark,  Hungary,  India,  Israel,  Italy,  Philippines,  Poland,  Portugal,  Slovakia,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Change From Baseline in Best Corrected Visual Acuity	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. A positive change from baseline value represents an improvement in vision.	6 months
Secondary	Mean Change From Baseline in Central Subfield Thickness	Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.	6 months