Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO
- Conditions
- Retinal Vein OcclusionMacular Edema
- Interventions
- Registration Number
- NCT03203447
- Lead Sponsor
- Clearside Biomedical, Inc.
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 325
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Lucentis or Avastin Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection Active suprachoroidal CLS-TA Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection Control suprachoroidal sham Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure Control Lucentis or Avastin Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure
- Primary Outcome Measures
Name Time Method Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) 2 months 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.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in Best Corrected Visual Acuity 6 months 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.
Mean Change From Baseline in Central Subfield Thickness 6 months 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.
Trial Locations
- Locations (86)
Win Retina
🇺🇸Arcadia, California, United States
Retina Vitreous Medical Group
🇺🇸Beverly Hills, California, United States
Macula and Retina Institute
🇺🇸Glendale, California, United States
Retinal Diagnostic Center
🇺🇸Campbell, California, United States
Stanford University - Byers Eye Institute
🇺🇸Palo Alto, California, United States
American Institute of Research
🇺🇸Whittier, California, United States
Retina Consultants of Southern California
🇺🇸Redlands, California, United States
Retina Group of New England, PC
🇺🇸New London, Connecticut, United States
Florida Eye Microsurgical Institute
🇺🇸Boynton Beach, Florida, United States
Specialty Retina Center
🇺🇸Coral Springs, Florida, United States
Eye Associates of Pinellas
🇺🇸Pinellas Park, Florida, United States
Retina Vitreous Associates of Florida
🇺🇸Saint Petersburg, Florida, United States
East Florida Eye Institute EFEI
🇺🇸Stuart, Florida, United States
Gailey Eye Clinic
🇺🇸Bloomington, Illinois, United States
Center for Retina And Macular Disease
🇺🇸Winter Haven, Florida, United States
Retina Consultants of Hawaii
🇺🇸'Aiea, Hawaii, United States
Prairie Eye Center, Ltd.
🇺🇸Springfield, Illinois, United States
University and Macula Associates
🇺🇸Oak Forest, Illinois, United States
Retina Specialists
🇺🇸Plano, Texas, United States
Vitreo-Retinal Consultants and Surgeons PA
🇺🇸Wichita, Kansas, United States
The National Retina Institute
🇺🇸Towson, Maryland, United States
Retina Associates of Western New York
🇺🇸Rochester, New York, United States
Retina Associates of St. Louis
🇺🇸Florissant, Missouri, United States
Ophthalmic Consultants of Long Island
🇺🇸Lynbrook, New York, United States
Retina Associates of Cleveland Inc
🇺🇸Middleburg Heights, Ohio, United States
Island Retina
🇺🇸Shirley, New York, United States
Pennsylvania Retina Specialists PC
🇺🇸Camp Hill, Pennsylvania, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Strategic Clinical Research Group, LLC
🇺🇸Willow Park, Texas, United States
Eye Clinic Albury Wodonga
🇦🇺Albury, New South Wales, Australia
Strathfield Retina Clinic
🇦🇺Strathfield, New South Wales, Australia
MH EK Honvédkórház
🇭🇺Budapest, Hungary
LV Prasad Eye Institute
🇮🇳Patia, Bhubaneswar, India
M&J Western Regional Institute of Ophthalmology
🇮🇳Asarwa, Gujarat, India
Dr Shroff 's Charity Eye Hospital
🇮🇳Delhi, New Delhi, India
B B Eye Foundation VIP
🇮🇳Kolkata, Raghunathpur, India
Disha Eye Hospitals Pvt. Ltd.
🇮🇳Kolkata, West Bengal, India
Auckland Eye
🇳🇿Auckland, New Zealand
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
Retina Vitreous Associates Medical Group Inc
🇺🇸Mountain View, California, United States
National Ophthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
Center for Retina Care at The Eye Institute
🇺🇸Melbourne, Florida, United States
Southern Vitreoretinal Association
🇺🇸Tallahassee, Florida, United States
Paducah Retinal Center
🇺🇸Paducah, Kentucky, United States
The Retina Care Center
🇺🇸Baltimore, Maryland, United States
Retina Group of Washington
🇺🇸Fairfax, Virginia, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Associated Retinal Consultants P.C.
🇺🇸Royal Oak, Michigan, United States
Retina-Vitreous Surgeons of Central New York
🇺🇸Syracuse, New York, United States
Texas Retina Associates - Arlington
🇺🇸Arlington, Texas, United States
Texas Retina Associates
🇺🇸Dallas, Texas, United States
Retina and Vitreous of Texas, PLLC
🇺🇸Houston, Texas, United States
Retina Consultants of Houston, PA
🇺🇸The Woodlands, Texas, United States
West Virginia University Medicine Eye Institute
🇺🇸Morgantown, West Virginia, United States
Save Sight Institute, University of Sydney (Sydney Eye Hospital)
🇦🇺Sydney, New South Wales, Australia
Retina Consultants of Nevada
🇺🇸Las Vegas, Nevada, United States
San Antonio Eye Center
🇺🇸San Antonio, Texas, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Retina Associates of South Texas PA
🇺🇸San Antonio, Texas, United States
Aravind Eye Hospital
🇮🇳Madurai, Tamil Nadu, India
Central Plains Eye MDs
🇺🇸Wichita, Kansas, United States
SMS Hospital
🇮🇳Jaipur, Rajasthan, India
Sabates Eye Centers
🇺🇸Leawood, Kansas, United States
Retina Associates Southwest PC
🇺🇸Tucson, Arizona, United States
R.P. Centre, AIIMS
🇮🇳New Delhi, Ansari Nagar, India
Retina Centers PC
🇺🇸Tucson, Arizona, United States
Associated Retinal Consultants PC
🇺🇸Traverse City, Michigan, United States
Retina Consultants of Michigan
🇺🇸Southfield, Michigan, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
L V Prasad Eye Institute
🇮🇳Visakhapatnam, Andhra Pradesh, India
New England Retina Consultants
🇺🇸Springfield, Massachusetts, United States
Raghudeep Eye Hospital
🇮🇳Gujrat, Ahmedabad, India
Regional Institute of Ophthalmology
🇮🇳Bihar, Patna, India
Jawaharlal Rohatgi Eye Hospital
🇮🇳Kanpur, Uttar Pradesh, India
Narayana Nethralaya
🇮🇳RajajiNagar, Bangalaore, India
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
PBMA's H.V Desai Eye Hospital
🇮🇳Pune, Maharashtra, India
Vitreo-Retinal Associates, P.C.
🇺🇸Grand Rapids, Michigan, United States
Retinal Research Institute
🇺🇸Phoenix, Arizona, United States
Dean A. McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
Rocky Mountain Retina Consultants
🇺🇸Salt Lake City, Utah, United States
Retina Consultants Medical Group Inc
🇺🇸Sacramento, California, United States
Florida Retina Institute
🇺🇸Orlando, Florida, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Retina Research Center
🇺🇸Austin, Texas, United States
Valley Retina Institute, PA
🇺🇸McAllen, Texas, United States