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

NCT03203447 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: CLS1003-302
• Study Type: interventional
• Target: 325
• Locations: 5 countries
• Sites: 92

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.

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

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

ACTIVE COMPARATOR

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

Drug: suprachoroidal CLS-TA; Drug: Lucentis or Avastin

Control

SHAM COMPARATOR

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

Drug: suprachoroidal sham; Drug: Lucentis or Avastin

Interventions

suprachoroidal CLS-TA DRUG

suprachoroidal injection of CLS-TA

Also known as: Triamcinolone acetonide

Active

suprachoroidal sham DRUG

sham suprachoroidal procedure

Control

Lucentis or Avastin DRUG

IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin

Also known as: IVT anti-VEGF agent

Active; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Clearside Biomedical, Inc.: lead

Study Sites (92)

Retinal Research Institute

Phoenix, Arizona, 85053, United States

Location

Retina Centers PC

Tucson, Arizona, 85704, United States

Location

Retina Associates Southwest PC

Tucson, Arizona, 85710, United States

Location

Win Retina

Arcadia, California, 91006, United States

Location

Retina Vitreous Medical Group

Beverly Hills, California, 90211, United States

Location

Retinal Diagnostic Center

Campbell, California, 95008, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835, United States

Location

Macula and Retina Institute

Glendale, California, 91203, United States

Location

American Institute of Research

Los Angeles, California, 90017, United States

Location

Retina Vitreous Associates Medical Group Inc

Mountain View, California, 94040, United States

Location

Stanford University - Byers Eye Institute

Palo Alto, California, 94303, United States

Location

Retina Consultants of Southern California

Redlands, California, 92374, United States

Location

Retina Consultants Medical Group Inc

Sacramento, California, 95819, United States

Location

American Institute of Research

Whittier, California, 90603, United States

Location

Retina Group of New England, PC

New London, Connecticut, 06320, United States

Location

Florida Eye Microsurgical Institute

Boynton Beach, Florida, 33426, United States

Location

Specialty Retina Center

Coral Springs, Florida, 33067, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

Center for Retina Care at The Eye Institute

Melbourne, Florida, 32904, United States

Location

Florida Retina Institute

Orlando, Florida, 32806, United States

Location

Eye Associates of Pinellas

Pinellas Park, Florida, 33782, United States

Location

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

Location

East Florida Eye Institute EFEI

Stuart, Florida, 34994, United States

Location

Southern Vitreoretinal Association

Tallahassee, Florida, 32308, United States

Location

Center for Retina And Macular Disease

Winter Haven, Florida, 33880, United States

Location

Retina Consultants of Hawaii

‘Aiea, Hawaii, 96701, United States

Location

Gailey Eye Clinic

Bloomington, Illinois, 61704, United States

Location

University and Macula Associates

Oak Forest, Illinois, 60452, United States

Location

Prairie Eye Center, Ltd.

Springfield, Illinois, 62704, United States

Location

Sabates Eye Centers

Leawood, Kansas, 66211, United States

Location

Vitreo-Retinal Consultants and Surgeons PA

Wichita, Kansas, 67214, United States

Location

Central Plains Eye MDs

Wichita, Kansas, 67226, United States

Location

Paducah Retinal Center

Paducah, Kentucky, 42001, United States

Location

Retina Specialists

Baltimore, Maryland, 21204, United States

Location

The Retina Care Center

Baltimore, Maryland, 21209, United States

Location

Retina Group of Washington

Chevy Chase, Maryland, 20815, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

The National Retina Institute

Towson, Maryland, 21204, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

New England Retina Consultants

Springfield, Massachusetts, 01107, United States

Location

Associated Retinal Consultants PC

Grand Rapids, Michigan, 49546, United States

Location

Vitreo-Retinal Associates, P.C.

Grand Rapids, Michigan, 49546, United States

Location

Associated Retinal Consultants P.C.

Royal Oak, Michigan, 48073, United States

Location

Retina Consultants of Michigan

Southfield, Michigan, 48034, United States

Location

Associated Retinal Consultants PC

Traverse City, Michigan, 49686, United States

Location

Retina Associates of St. Louis

Florissant, Missouri, 63031, United States

Location

Retina Consultants of Nevada

Las Vegas, Nevada, 89144, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Ophthalmic Consultants of Long Island

Lynbrook, New York, 11563, United States

Location

Retina Associates of Western New York

Rochester, New York, 14620, United States

Location

Island Retina

Shirley, New York, 11967, United States

Location

Retina-Vitreous Surgeons of Central New York

Syracuse, New York, 13224, United States

Location

Retina Associates of Cleveland Inc

Middleburg Heights, Ohio, 44130, United States

Location

Dean A. McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Pennsylvania Retina Specialists PC

Camp Hill, Pennsylvania, 17011, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Texas Retina Associates - Arlington

Arlington, Texas, 76012, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Retina Research Center

Austin, Texas, 78705, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Retina and Vitreous of Texas, PLLC

Houston, Texas, 77025, United States

Location

Retina Consultants of Houston, PA

Houston, Texas, 77030, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

Retina Specialists

Plano, Texas, 75093, United States

Location

San Antonio Eye Center

San Antonio, Texas, 78215, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Retina Associates of South Texas PA

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Houston, PA

The Woodlands, Texas, 77384, United States

Location

Strategic Clinical Research Group, LLC

Willow Park, Texas, 76087, United States

Location

Rocky Mountain Retina Consultants

Salt Lake City, Utah, 84107, United States

Location

Retina Group of Washington

Fairfax, Virginia, 22031, United States

Location

West Virginia University Medicine Eye Institute

Morgantown, West Virginia, 26506, United States

Location

Eye Clinic Albury Wodonga

Albury, New South Wales, 2640, Australia

Location

Strathfield Retina Clinic

Strathfield, New South Wales, 2135, Australia

Location

Save Sight Institute, University of Sydney (Sydney Eye Hospital)

Sydney, New South Wales, 2000, Australia

Location

MH EK Honvédkórház

Budapest, 1062, Hungary

Location

Raghudeep Eye Hospital

Gujrāt, Ahmedabad, 380052, India

Location

LV Prasad Eye Institute

Hyderabad, Andhra Pradesh, 500034, India

Location

L V Prasad Eye Institute

Visakhapatnam, Andhra Pradesh, 530040, India

Location

R.P. Centre, AIIMS

New Delhi, Ansari Nagar, 110029, India

Location

Narayana Nethralaya

RajajiNagar, Bangalaore, 560010, India

Location

LV Prasad Eye Institute

Pātia, Bhubaneswar, 751024, India

Location

M&J Western Regional Institute of Ophthalmology

Asarwa, Gujarat, 380016, India

Location

PBMA's H.V Desai Eye Hospital

Pune, Maharashtra, 411060, India

Location

Dr Shroff 's Charity Eye Hospital

Delhi, New Delhi, 758770, India

Location

Regional Institute of Ophthalmology

Bihār, Patna, 800001, India

Location

B B Eye Foundation VIP

Kolkata, Raghunathpur, 700059, India

Location

SMS Hospital

Jaipur, Rajasthan, 302004, India

Location

Aravind Eye Hospital

Madurai, Tamil Nadu, 625020, India

Location

Jawaharlal Rohatgi Eye Hospital

Kanpur, Uttar Pradesh, 208005, India

Location

Disha Eye Hospitals Pvt. Ltd.

Kolkata, West Bengal, 700120, India

Location

Auckland Eye

Auckland, 1050, New Zealand

Location

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion

Interventions

Triamcinolone Acetonide; Ranibizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Due to the early termination of the trial by sponsor, 325 of the planned 460 were enrolled. 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.

thomas.ciulla@clearsidebio.com

(678) 392-2318

Study Officials

• Thomas Ciulla, MD

  Chief Medical Officer

  STUDY DIRECTOR

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: June 28, 2017
• First Posted: June 29, 2017
• Study Start: March 5, 2018
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: April 23, 2021
• Results First Posted: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); US (72); AU (3); HU (1); IN (15)