Macular EdemaPhase 3SAPPHIRENCT02980874
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
A Phase 3 study testing suprachoroidal CLS-TA and IVT aflibercept in people with Macular Edema and Retinal Vein Occlusion, run by Clearside Biomedical, Inc. at 110 sites in 16 countries.
Trial summary
This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO. 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 IVT aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 110 sitesin 16 countries
- Study dates
- 31 Jan 2017to 10 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
110 sites in 16 countries.
110 sites in 16 countries
United States58 sites
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701
Retina Research Institute of Texas
Abilene, Texas, 79606-1224
Texas Retina Associates-Arlington
Arlington, Texas, 76012-2505
Western Carolina Retinal Associates, PA
Asheville, North Carolina, 28803
Emory Eye Center
Atlanta, Georgia, 30322
Southeast Retina Center, PC
Augusta, Georgia, 30909
Austin Retina Associates
Austin, Texas, 78705
California Retina Research Consultants
Bakersfield, California, 93309
Wilmer Eye Institute John Hopkins University
Baltimore, Maryland, 21287-0005
Retina Vitreous Medical Group Clinical Research
Beverly Hills, California, 90211-1841
Illinois Eye and Ear Infirmary, UIC
Chicago, Illinois, 60612
Illinois Retina Associates
Chicago, Illinois, 60657
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Cleveland Clinic Foundation/Cole Eye Institute
Cleveland, Ohio, 44195
Texas Retina Associates
Dallas, Texas, 75231
Colorado Retina Associates
Golden, Colorado, 80401
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740-5940
New England Retina Associates
Hamden, Connecticut, 06518
Retina Consultants of Houston
Houston, Texas, 77030
Atlantis Eyecare
Huntington Beach, California, 92647
Midwest Eye Institute
Indianapolis, Indiana, 46290
Eye Care Specialists
Kingston, Pennsylvania, 18704
Jacobs Retina Center at the Shiley Eye Institute, UCSD
La Jolla, California, 92093
Retina and Vitrous Associates of Kentucky
Lexington, Kentucky, 40509
University of Wisconsin-Madison
Madison, Wisconsin, 53705
Marietta Eye Clinic
Marietta, Georgia, 30060
Valley Retina Institute
McAllen, Texas, 78503
Oregon Retina Institute
Medford, Oregon, 97504
MedEye Associates
Miami, Florida, 33143-5188
Northern California Retina Vitreous Associates
Mountain View, California, 94040
East Bay Retina Consultants Inc.
Oakland, California, 95409
Southern California Desert Retina Consultants
Palm Desert, California, 92211
Retina Institute of California
Palm Desert, California, 92260
Retina Specialty Institute
Pensacola, Florida, 32503
Associated Retina Consultants, Ltd.
Peoria, Arizona, 85381
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Retinal Consultants of Arizona and Retinal Research Institute
Phoenix, Arizona, 85014-2709
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, 85021
Associated Retina Consultants, Ltd.
Phoenix, Arizona, 85381
Casey Eye Institute/Oregon Health & Science University
Portland, Oregon, 97239
Retina Consultants San Diego
Poway, California, 92064-2526
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701-7374
Retina Institute of Virginia
Richmond, Virginia, 23235
University of Utah HSC - John A. Moran Eye Center
Salt Lake City, Utah, 84132
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240-1502
Orange County Retina Medical Group
Santa Ana, California, 92705
California Retina Consultants CRC
Santa Barbara, California, 93103
Sarasota Retina Institute
Sarasota, Florida, 34239
Retina Associates, PA
Shawnee Mission, Kansas, 66204
The Retina Institute
St Louis, Missouri, 63128
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711
Retina Associates of NJ
Teaneck, New Jersey, 07666
Retina Consultants of Houston
The Woodlands, Texas, 77384
Retina Centers P.C.
Tucson, Arizona, 85704
Carle Foundation Hospital
Urbana, Illinois, 61801
Bay Area Retina Associates
Walnut Creek, California, 94599
Virginia Retina Center
Warrenton, Virginia, 20186
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
Spain8 sites
Hospital General de Catalunya
Barcelona
Hospital Universitari de Bellvitge
Barcelona
Instituto Cinico Quirurgico de Oftalmologia
Bilbao, Vizcaya, 48006
Hospital Clinico San Carlos
Madrid, 28040
Instituto Oftalmologico Fernandez-Vega
Oviedo, 33012
Clinica Universidad de Navarra
Pamplona, 31008
Hospital Universitario Miguel Servet
Zaragoza, 50009
Hospital Clinico Universitario
Zaragoza
Australia6 sites
The Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, 3002
Specialist Eye Group
Melbourne, Victoria, 3150
Strathfield Retina Clinic
Strathfield, New South Wales, 2135
Save Site Institute, University of Sydney, Sydney Eye Hospital
Sydney, New South Wales, 2000
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, 2000
Marsden Eye Specialists
Sydney, New South Wales, 2150
Hungary6 sites
Semmelweis Egyetem, Szemeszeti Klinika
Budapest, 1083
Bajcsy-Zsilinszky Korhaz es Rendelointezet, Szemeszeti Osztaly
Budapest, 1106
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1162
Budapest Retina Associates
Budapest
Debreceni Egyetem Klinikai Kozpont, Szemklinika
Debrecen, 4032
Ganglion Orvosi Kozpont
Pécs, 7621
India6 sites
M&J Western Regional Institute of Ophthalmology
Ahmedabad, Gujarat, 380016
Department of Medical Ophthalmology, Retina & Uvea
Delhi, New Delhi, 110029
Smt. Kanuri Santhamma Centre for Vitreo Retinal Diseases
Hyderabad, Telangana, 500034
Disha Eye Hospital Private Limited
Kolkata, West Bengal, 700120
Aravind Eye Hospitals & Postgraduate Institute of Ophthalmology
Madurai, Tamil Nadu, 625020
T.N. Medical College and B.Y.L. Nair Charitable Hospital
Mumbai, Maharashtra, 400008
Canada5 sites
Institut de l'oeil des Laurentides
Boisbriand, Quebec, J7H 1S6
St. Joseph's Health Care London, Ivey Eye Institute
London, Ontario, N6A 4V2
CIUSSS de l'Est-de-l'Ile-de-Montreal. Hospital Maisonneuve-Rosemont, Comite d'ethique de la recherche
Montreal, Quebec, H1T 2M4
University of Ottawa Eye Institute
Ottawa, Ontario, K1H 8L6
UBC/VGH Eye Care Centre
Vancouver, British Columbia, V5Z 3N9
Poland4 sites
Oftalmika sp. z o. o.
Bydgoszcz, 85-631
Optimum Profesorskie Centrum Okulistyki
Gdansk, 80-809
Uniwersytet Medyczny w Lublinie
Lublin, 20-079
Centrum Diagnostyki i Mikrochirurgii Oka Lens
Olsztyn, 10-424
Philippines3 sites
Cebu Doctor's University Hospital
Cebu City, 6000
Peregrine Eye & Laser Institute
Makati City, 1209
The Medical City
Pasig, 1600
Portugal3 sites
Centro Clinico Academico Braga - 2CA-Braga
Braga, 4710-243
Centro Hospitalar e Universitario de Coimbra, E.P.E.
Coimbra, 3000-075
Centro Hospitalar de Sao Joao, E.P.E.
Porto, 4200-319
Austria2 sites
University of Graz-Department of Ophthalmology
Graz
Kepler University Hospital
Linz
Denmark2 sites
Rigshospitalet
Glostrup Municipality
Dept. of Ophthalmology, Sjællands Universitetshospital, Roskilde
Roskilde
Taiwan2 sites
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
Taipei Veterans General Hospital
Taipei, 112
United Kingdom2 sites
Queens University Royal Victoria Hospital Trust
Belfast, BT12 6BJ
Sunderland Eye Infirmary
Sunderland
Italy1 site
ASST Fatebenefratelli Sacco - P.O.L., University of Milan, Dep. of Ophthalmology
Milan, 20157
About this study
Official title: SAPPHIRE: A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Conjunction With Intravitreal Aflibercept In Subjects With Retinal Vein Occlusion
This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.
Read the detailed description
A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Being tested
- suprachoroidal CLS-TA, suprachoroidal sham, IVT aflibercept
- Keywords
- RVO, ME, Central Subfield Thickness, OCT, Optical Coherence Tomography, Cystoid Macular Edema, Subretinal Fluid, Eylea, Aflibercept, Anti-VEGF, Suprachoroidal, 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
suprachoroidal sham procedure
IVT afliberceptDrug
Also called Aflibercept
2 mg intravitreal injection of aflibercept
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections Receives: Drug: suprachoroidal CLS-TA; Drug: IVT aflibercept |
| Control | Active comparator | IVT aflibercept (2 mg/0.05 mL) + sham SC procedure Receives: Drug: suprachoroidal sham; Drug: IVT aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted2 Dec 2016 (estimated)
- Study start31 Jan 2017
- Primary completion10 Dec 2018
- Study completion10 Dec 2018
Why it stopped: Primary, 8-week efficacy endpoint not achieved. No additional benefit for subjects receiving a corticosteroid together with an intravitreal anti-VEGF agent.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clearside Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Ciulla, MD MBA, Study director, Clearside Biomedical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980874
- Sponsor's protocol ID
- CLS1003-301
- Acronym
- SAPPHIRE
- Status last verified
- Mar 2021
- First submitted
- 30 Nov 2016
- Last updated
- 14 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAPPHIRE: A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Conjunction With Intravitreal Aflibercept In Subjects With Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT02980874
- Acronym / sponsor ID
- SAPPHIRE / CLS1003-301
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Keywords
- RVO, ME, Central Subfield Thickness, OCT, Optical Coherence Tomography, Cystoid Macular Edema, Subretinal Fluid, Eylea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary, 8-week efficacy endpoint not achieved. No additional benefit for subjects receiving a corticosteroid together with an intravitreal anti-VEGF agent.
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Clearside Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Posted 14 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.
Detailed description
A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: suprachoroidal CLS-TA, Drug: IVT afliberceptIVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections |
| Control | Active comparator | Drug: suprachoroidal sham, Drug: IVT afliberceptIVT aflibercept (2 mg/0.05 mL) + sham SC procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suprachoroidal CLS-TAAlso: Triamcinolone acetonidesuprachoroidal injection of CLS-TA | Drug | Active |
| suprachoroidal shamsuprachoroidal sham procedure | Drug | Control |
| IVT afliberceptAlso: Aflibercept2 mg intravitreal injection of aflibercept | Drug | Active, Control |
Primary outcome
Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)
Time frame: 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.
2 secondary outcomes
Mean Change From Baseline in Best Corrected Visual Acuity
Time frame: 6 months
Mean Change From Baseline in Central Subfield Thickness
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Ciulla, MD MBA study director
Clearside Biomedical, Inc.
110 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing suprachoroidal CLS-TA and IVT aflibercept in people with Macular Edema and Retinal Vein Occlusion, run by Clearside Biomedical, Inc. at 110 sites in 16 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 14 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 110 sites in United States, Spain, Australia, Hungary, India and 11 more countries. 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. 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 14 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?
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 14 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.