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Macular EdemaPhase 3TOPAZNCT03203447

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

A Phase 3 study testing suprachoroidal CLS-TA and Lucentis or Avastin in people with Macular Edema and Retinal Vein Occlusion, run by Clearside Biomedical, Inc. at 92 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Macular Edema, Retinal Vein Occlusion
What is being tested?
suprachoroidal CLS-TA and Lucentis or Avastin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
325 participants
Where
92 sitesin 5 countries
Study dates
5 Mar 2018to 18 Dec 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

92 sites in 5 countries.

92 sites in 5 countries

United States72 sites

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701

  • Win Retina

    Arcadia, California, 91006

  • Texas Retina Associates - Arlington

    Arlington, Texas, 76012

  • Austin Retina Associates

    Austin, Texas, 78705

  • Retina Research Center

    Austin, Texas, 78705

  • Retina Specialists

    Baltimore, Maryland, 21204

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Retina Vitreous Medical Group

    Beverly Hills, California, 90211

  • Gailey Eye Clinic

    Bloomington, Illinois, 61704

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Florida Eye Microsurgical Institute

    Boynton Beach, Florida, 33426

  • Pennsylvania Retina Specialists PC

    Camp Hill, Pennsylvania, 17011

  • Retinal Diagnostic Center

    Campbell, California, 95008

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Specialty Retina Center

    Coral Springs, Florida, 33067

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Retina Group of Washington

    Fairfax, Virginia, 22031

  • Retina Associates of St. Louis

    Florissant, Missouri, 63031

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Macula and Retina Institute

    Glendale, California, 91203

  • Associated Retinal Consultants PC

    Grand Rapids, Michigan, 49546

  • Vitreo-Retinal Associates, P.C.

    Grand Rapids, Michigan, 49546

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Retina and Vitreous of Texas, PLLC

    Houston, Texas, 77025

  • Retina Consultants of Houston, PA

    Houston, Texas, 77030

  • Retina Consultants of Nevada

    Las Vegas, Nevada, 89144

  • Sabates Eye Centers

    Leawood, Kansas, 66211

  • American Institute of Research

    Los Angeles, California, 90017

  • Ophthalmic Consultants of Long Island

    Lynbrook, New York, 11563

  • Valley Retina Institute, PA

    McAllen, Texas, 78503

  • Center for Retina Care at The Eye Institute

    Melbourne, Florida, 32904

  • Retina Associates of Cleveland Inc

    Middleburg Heights, Ohio, 44130

  • West Virginia University Medicine Eye Institute

    Morgantown, West Virginia, 26506

  • Retina Vitreous Associates Medical Group Inc

    Mountain View, California, 94040

  • Retina Group of New England, PC

    New London, Connecticut, 06320

  • University and Macula Associates

    Oak Forest, Illinois, 60452

  • Dean A. McGee Eye Institute

    Oklahoma City, Oklahoma, 73104

  • Florida Retina Institute

    Orlando, Florida, 32806

  • Paducah Retinal Center

    Paducah, Kentucky, 42001

  • Stanford University - Byers Eye Institute

    Palo Alto, California, 94303

  • Retinal Research Institute

    Phoenix, Arizona, 85053

  • Eye Associates of Pinellas

    Pinellas Park, Florida, 33782

  • Retina Specialists

    Plano, Texas, 75093

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Associates of Western New York

    Rochester, New York, 14620

  • Associated Retinal Consultants P.C.

    Royal Oak, Michigan, 48073

  • Retina Consultants Medical Group Inc

    Sacramento, California, 95819

  • Rocky Mountain Retina Consultants

    Salt Lake City, Utah, 84107

  • San Antonio Eye Center

    San Antonio, Texas, 78215

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Retina Associates of South Texas PA

    San Antonio, Texas, 78240

  • Island Retina

    Shirley, New York, 11967

  • Retina Consultants of Michigan

    Southfield, Michigan, 48034

  • Prairie Eye Center, Ltd.

    Springfield, Illinois, 62704

  • New England Retina Consultants

    Springfield, Massachusetts, 01107

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711

  • East Florida Eye Institute EFEI

    Stuart, Florida, 34994

  • Retina-Vitreous Surgeons of Central New York

    Syracuse, New York, 13224

  • Southern Vitreoretinal Association

    Tallahassee, Florida, 32308

  • Retina Consultants of Houston, PA

    The Woodlands, Texas, 77384

  • The National Retina Institute

    Towson, Maryland, 21204

  • Associated Retinal Consultants PC

    Traverse City, Michigan, 49686

  • Retina Centers PC

    Tucson, Arizona, 85704

  • Retina Associates Southwest PC

    Tucson, Arizona, 85710

  • American Institute of Research

    Whittier, California, 90603

  • Vitreo-Retinal Consultants and Surgeons PA

    Wichita, Kansas, 67214

  • Central Plains Eye MDs

    Wichita, Kansas, 67226

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Center for Retina And Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

India15 sites

  • M&J Western Regional Institute of Ophthalmology

    Asarwa, Gujarat, 380016

  • Regional Institute of Ophthalmology

    Bihār, Patna, 800001

  • Dr Shroff 's Charity Eye Hospital

    Delhi, New Delhi, 758770

  • Raghudeep Eye Hospital

    Gujrāt, Ahmedabad, 380052

  • LV Prasad Eye Institute

    Hyderabad, Andhra Pradesh, 500034

  • SMS Hospital

    Jaipur, Rajasthan, 302004

  • Jawaharlal Rohatgi Eye Hospital

    Kanpur, Uttar Pradesh, 208005

  • B B Eye Foundation VIP

    Kolkata, Raghunathpur, 700059

  • Disha Eye Hospitals Pvt. Ltd.

    Kolkata, West Bengal, 700120

  • Aravind Eye Hospital

    Madurai, Tamil Nadu, 625020

  • R.P. Centre, AIIMS

    New Delhi, Ansari Nagar, 110029

  • LV Prasad Eye Institute

    Pātia, Bhubaneswar, 751024

  • PBMA's H.V Desai Eye Hospital

    Pune, Maharashtra, 411060

  • Narayana Nethralaya

    RajajiNagar, Bangalaore, 560010

  • L V Prasad Eye Institute

    Visakhapatnam, Andhra Pradesh, 530040

Other trials in India

Australia3 sites

  • Eye Clinic Albury Wodonga

    Albury, New South Wales, 2640

  • Strathfield Retina Clinic

    Strathfield, New South Wales, 2135

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

    Sydney, New South Wales, 2000

Other trials in Australia

Hungary1 site

  • MH EK Honvédkórház

    Budapest, 1062

Other trials in Hungary

New Zealand1 site

  • Auckland Eye

    Auckland, 1050

Other trials in New Zealand

About this study

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

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.

Read the 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

Being tested
suprachoroidal CLS-TA, suprachoroidal sham, Lucentis or Avastin
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
Medical subject headings
Macular Edema, Retinal Vein Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • suprachoroidal CLS-TADrug

    Also called Triamcinolone acetonide

    suprachoroidal injection of CLS-TA

  • suprachoroidal shamDrug

    sham suprachoroidal procedure

  • Lucentis or AvastinDrug

    Also called IVT anti-VEGF agent

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

Study groups in NCT03203447
Study groupRoleWhat they receive
ActiveActive comparatorLucentis (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
Receives: Drug: suprachoroidal CLS-TA; Drug: Lucentis or Avastin
ControlSham comparatorLucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure
Receives: Drug: suprachoroidal sham; Drug: Lucentis or Avastin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 months

Secondary outcomes (2)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2017
  2. Study start5 Mar 2018
  3. Primary completion18 Dec 2018
  4. Study completion18 Dec 2018

Why it stopped: The early termination is due to the results obtained from the sister study, SAPPHIRE (CLS1003-301), which did not meet the 8-week primary efficacy endpoint.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
325 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03203447
Sponsor's protocol ID
CLS1003-302
Acronym
TOPAZ
Status last verified
Apr 2021
First submitted
28 Jun 2017
Last updated
23 Apr 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing suprachoroidal CLS-TA and Lucentis or Avastin in people with Macular Edema and Retinal Vein Occlusion, run by Clearside Biomedical, Inc. at 92 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, India, Australia, Hungary, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03203447.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.

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