Clinical trial NCT03203447: Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Macular Edema
Retinal Vein Occlusion
Keywords: RVO
ME
Microneedle
Microinjection
Triamcinolone
Choroid
Choroid injection
Suprachoroidal
Anti-VEGF
Subretinal Fluid
Cystoid Macular Edema
Optical Coherence Tomography
OCT
Central Subfield Thickness
Lucentis
Avastin
Ranibizumab
Bevacizumab
Triamcinolone acetonide
Lead sponsor: Clearside Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-29
Enrollment: 325
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 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.

Detailed 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

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