Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO

Macular Edema Clinical Trial

— TOPAZ  

Official title:

A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Combination With An Intravitreal Anti-VEGF Agent In Subjects With Retinal Vein Occlusion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03203447
• Other study ID #: CLS1003-302
• Status: Terminated
• Phase: Phase 3
• Start date: March 5, 2018
• Est. completion date: December 18, 2018

Study information

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

Clinical Trial Summary

This Phase 3, multicenter, randomized, masked, controlled, parallel group study is designed to demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT) anti-VEGF agent in subjects with treatment naive RVO is superior to IVT anti-VEGF agent used alone.

Description:

A Randomized, Masked, Controlled Trial to Study the Safety and Efficacy of Suprachoroidal CLS-TA With Intravitreal Anti-VEGF Agent in Subjects With Retinal Vein Occlusion

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 325
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 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
sham suprachoroidal procedure
• Lucentis or Avastin
IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin

Locations

Country	Name	City	State
Australia	Eye Clinic Albury Wodonga	Albury	New South Wales
Australia	Strathfield Retina Clinic	Strathfield	New South Wales
Australia	Save Sight Institute, University of Sydney (Sydney Eye Hospital)	Sydney	New South Wales
Hungary	MH EK Honvédkórház	Budapest
India	M&J Western Regional Institute of Ophthalmology	Asarwa	Gujarat
India	Regional Institute of Ophthalmology	Bihar	Patna
India	Dr Shroff 's Charity Eye Hospital	Delhi	New Delhi
India	Raghudeep Eye Hospital	Gujrat	Ahmedabad
India	LV Prasad Eye Institute	Hyderabad	Andhra Pradesh
India	SMS Hospital	Jaipur	Rajasthan
India	Jawaharlal Rohatgi Eye Hospital	Kanpur	Uttar Pradesh
India	B B Eye Foundation VIP	Kolkata	Raghunathpur
India	Disha Eye Hospitals Pvt. Ltd.	Kolkata	West Bengal
India	Aravind Eye Hospital	Madurai	Tamil Nadu
India	R.P. Centre, AIIMS	New Delhi	Ansari Nagar
India	LV Prasad Eye Institute	Patia	Bhubaneswar
India	PBMA's H.V Desai Eye Hospital	Pune	Maharashtra
India	Narayana Nethralaya	RajajiNagar	Bangalaore
India	L V Prasad Eye Institute	Visakhapatnam	Andhra Pradesh
New Zealand	Auckland Eye	Auckland
United States	Retina Consultants of Hawaii	'Aiea	Hawaii
United States	Win Retina	Arcadia	California
United States	Texas Retina Associates - Arlington	Arlington	Texas
United States	Austin Retina Associates	Austin	Texas
United States	Retina Research Center	Austin	Texas
United States	Retina Specialists	Baltimore	Maryland
United States	The Retina Care Center	Baltimore	Maryland
United States	Retina Vitreous Medical Group	Beverly Hills	California
United States	Gailey Eye Clinic	Bloomington	Illinois
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Florida Eye Microsurgical Institute	Boynton Beach	Florida
United States	Pennsylvania Retina Specialists PC	Camp Hill	Pennsylvania
United States	Retinal Diagnostic Center	Campbell	California
United States	Retina Group of Washington	Chevy Chase	Maryland
United States	Specialty Retina Center	Coral Springs	Florida
United States	Texas Retina Associates	Dallas	Texas
United States	Retina Group of Washington	Fairfax	Virginia
United States	Retina Associates of St. Louis	Florissant	Missouri
United States	National Ophthalmic Research Institute	Fort Myers	Florida
United States	Retina Consultants of Orange County	Fullerton	California
United States	Macula and Retina Institute	Glendale	California
United States	Associated Retinal Consultants PC	Grand Rapids	Michigan
United States	Vitreo-Retinal Associates, P.C.	Grand Rapids	Michigan
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Retina and Vitreous of Texas, PLLC	Houston	Texas
United States	Retina Consultants of Houston, PA	Houston	Texas
United States	Retina Consultants of Nevada	Las Vegas	Nevada
United States	Sabates Eye Centers	Leawood	Kansas
United States	American Institute of Research	Los Angeles	California
United States	Ophthalmic Consultants of Long Island	Lynbrook	New York
United States	Valley Retina Institute, PA	McAllen	Texas
United States	Center for Retina Care at The Eye Institute	Melbourne	Florida
United States	Retina Associates of Cleveland Inc	Middleburg Heights	Ohio
United States	West Virginia University Medicine Eye Institute	Morgantown	West Virginia
United States	Retina Vitreous Associates Medical Group Inc	Mountain View	California
United States	Retina Group of New England, PC	New London	Connecticut
United States	University and Macula Associates	Oak Forest	Illinois
United States	Dean A. McGee Eye Institute	Oklahoma City	Oklahoma
United States	Florida Retina Institute	Orlando	Florida
United States	Paducah Retinal Center	Paducah	Kentucky
United States	Stanford University - Byers Eye Institute	Palo Alto	California
United States	Retinal Research Institute	Phoenix	Arizona
United States	Eye Associates of Pinellas	Pinellas Park	Florida
United States	Retina Specialists	Plano	Texas
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Retina Consultants of Southern California	Redlands	California
United States	Sierra Eye Associates	Reno	Nevada
United States	Retina Associates of Western New York	Rochester	New York
United States	Associated Retinal Consultants P.C.	Royal Oak	Michigan
United States	Retina Consultants Medical Group Inc	Sacramento	California
United States	Retina Vitreous Associates of Florida	Saint Petersburg	Florida
United States	Rocky Mountain Retina Consultants	Salt Lake City	Utah
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Retina Associates of South Texas PA	San Antonio	Texas
United States	San Antonio Eye Center	San Antonio	Texas
United States	Island Retina	Shirley	New York
United States	Retina Consultants of Michigan	Southfield	Michigan
United States	New England Retina Consultants	Springfield	Massachusetts
United States	Prairie Eye Center, Ltd.	Springfield	Illinois
United States	East Florida Eye Institute EFEI	Stuart	Florida
United States	Retina-Vitreous Surgeons of Central New York	Syracuse	New York
United States	Southern Vitreoretinal Association	Tallahassee	Florida
United States	Retina Consultants of Houston, PA	The Woodlands	Texas
United States	The National Retina Institute	Towson	Maryland
United States	Associated Retinal Consultants PC	Traverse City	Michigan
United States	Retina Associates Southwest PC	Tucson	Arizona
United States	Retina Centers PC	Tucson	Arizona
United States	American Institute of Research	Whittier	California
United States	Central Plains Eye MDs	Wichita	Kansas
United States	Vitreo-Retinal Consultants and Surgeons PA	Wichita	Kansas
United States	Strategic Clinical Research Group, LLC	Willow Park	Texas
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,  Hungary,  India,  New Zealand, 

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