Diabetic Macular EdemaPhase 2TYBEENCT03126786
Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema
A Phase 2 study testing IVT aflibercept and SC CLS-TA in people with Diabetic Macular Edema, run by Clearside Biomedical, Inc. at 29 sites in United States.
Trial summary
The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA used with intravitreal aflibercept in subjects with DME. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- IVT aflibercept and SC CLS-TA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 29 sitesUnited States
- Study dates
- 11 Jul 2017to 17 Apr 2018
- Phase
- Phase 2
- 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
- Clinical diagnosis of type 1 or type 2 DM
- DME with central involvement (> 300 µm in the central subfield on spectral-domain optical coherence tomography [SD-OCT], in the study eye
- ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye
- Naïve to local pharmacologic treatment for DME in the study eye
Who cannot join
- IOP > 21 mmHg in the study eye at Visit 1 (Day -30 to -1); subjects are not excluded if IOP is <22 mmHg in the study eye with no more than 1 IOP lowering medication
- Any previous treatment in the study eye with an ocular corticosteroid implant
- Has significant media opacity precluding evaluation of retina and vitreous in the study eye.
- History of glaucoma or optic nerve head change consistent with glaucoma damage
- History of glaucoma surgery
- History of clinically significant IOP elevation in response to corticosteroid treatment ("steroid responder")
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Retina Research Institute of Texas
Abilene, Texas, 79606-1224
Texas Retina Associates-Arlington
Arlington, Texas, 76012-2505
Western Carolina Retinal Associates
Asheville, North Carolina, 28803
Emory Eye Center
Augusta, Georgia, 30909-6440
Austin Retina Associates
Austin, Texas, 78705
California Retina Consultants
Bakersfield, California, 93309
The Johns Hopkins Wilmer Eye Institute
Baltimore, Maryland, 21287
Retina Vitreous Medical Group Clinical Research
Beverly Hills, California, 90211-1841
Texas Retina Associates
Dallas, Texas, 75231
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740-5940
Midwest Eye Institute
Indianapolis, Indiana, 46290
Retina and Vitrous Associates of Kentucky
Lexington, Kentucky, 40509
Marietta Eye Clinic
Marietta, Georgia, 30060
Valley Retina Institute, P.A.
McAllen, Texas, 78503
Valley Retina Institute
McAllen, Texas, 78503
Oregon Retina Institute
Medford, Oregon, 97504
MedEye Associates
Miami, Florida, 33143-5188
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, 94040
Retina Institute of California
Palm Desert, California, 92260
Retina Specialty Institute
Pensacola, Florida, 32503
Retinal Consultants of Arizona and Retinal Research Institute
Phoenix, Arizona, 85014-2709
Retina Consultants San Diego
Poway, California, 92064-2526
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701-7374
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240-1502
Sarasota Retina Institute
Sarasota, Florida, 34239
Retina Associates of NJ
Teaneck, New Jersey, 07666
Retina Consultants of Houston
The Woodlands, Texas, 77384
Retina Centers, PC
Tucson, Arizona, 85704
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
About this study
Official title: Randomized, Double Masked, Controlled Study Comparing the Safety and Efficacy of Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema
The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA used with intravitreal aflibercept in subjects with DME.
Read the detailed description
This is a Phase 2, multicenter, randomized, double-masked, controlled, parallel-group study of 6 months duration in treatment-naïve subjects with DME. This study is projected to enroll approximately 60 subjects, randomly assigned 1:1 to one of two treatment groups.
The study design includes up to 8 clinic visits over approximately 24 weeks. Subjects will attend visits for Screening (Visit 1, Days -30 to 0); Randomization and Baseline (Visit 2, Day 0 before dosing); Dosing and Evaluation (Visit 2 after dosing to Visit 5, Day 0 through Week 12); As-needed (PRN) Dosing and Follow up (Visit 6 through Visit 7, Week 16 through Week 20), and End of Study (Visit 8, Week 24).
- Conditions
- Diabetic Macular Edema
- Being tested
- IVT aflibercept, Sham SC, SC CLS-TA
- Keywords
- Diabetes Mellitus, Diabetic Retinopathy, Microneedle, Mircoinjection, Triamcinolone, Choroid, Choroid Injection, Aflibercept, Suprachoroidal, Triamcinolone acetonide
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVT afliberceptDrug
Also called Eylea
IVT aflibercept [2 mg/0.05 mL]
Sham SCDrug
Also called suprachoroidal sham
sham SC
SC CLS-TADrug
Also called Triamcinolone Acetonide
CLS-TA [4 mg/100 μL] SC injection
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA Receives: Drug: IVT aflibercept; Drug: SC CLS-TA |
| Control | Sham comparator | Treatment will consist of IVT aflibercept injection followed by a sham SC procedure Receives: Drug: IVT aflibercept; Drug: Sham SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Best Corrected Visual Acuity Letter Score
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: Baseline, 6 months
Secondary outcomes (1)
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: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start11 Jul 2017
- Primary completion17 Apr 2018
- Study completion17 Apr 2018
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 Diabetic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clearside Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Ciulla, MD, Study director, Clearside Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126786
- Sponsor's protocol ID
- CLS1004-201
- Acronym
- TYBEE
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2017
- Last updated
- 13 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Masked, Controlled Study Comparing the Safety and Efficacy of Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT03126786
- Acronym / sponsor ID
- TYBEE / CLS1004-201
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetes Mellitus, Diabetic Retinopathy, Microneedle, Mircoinjection, Triamcinolone, Choroid, Choroid Injection, Aflibercept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Clearside Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 17 Apr 2018 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Posted 13 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA used with intravitreal aflibercept in subjects with DME.
Detailed description
This is a Phase 2, multicenter, randomized, double-masked, controlled, parallel-group study of 6 months duration in treatment-naïve subjects with DME. This study is projected to enroll approximately 60 subjects, randomly assigned 1:1 to one of two treatment groups.
The study design includes up to 8 clinic visits over approximately 24 weeks. Subjects will attend visits for Screening (Visit 1, Days -30 to 0); Randomization and Baseline (Visit 2, Day 0 before dosing); Dosing and Evaluation (Visit 2 after dosing to Visit 5, Day 0 through Week 12); As-needed (PRN) Dosing and Follow up (Visit 6 through Visit 7, Week 16 through Week 20), and End of Study (Visit 8, Week 24).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: IVT aflibercept, Drug: SC CLS-TATreatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA |
| Control | Sham comparator | Drug: IVT aflibercept, Drug: Sham SCTreatment will consist of IVT aflibercept injection followed by a 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)
- Clinical diagnosis of type 1 or type 2 DM
- DME with central involvement (> 300 µm in the central subfield on spectral-domain optical coherence tomography [SD-OCT], in the study eye
- ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye
- Naïve to local pharmacologic treatment for DME in the study eye
Key exclusion criteria (6 listed)
- IOP > 21 mmHg in the study eye at Visit 1 (Day -30 to -1); subjects are not excluded if IOP is <22 mmHg in the study eye with no more than 1 IOP lowering medication
- Any previous treatment in the study eye with an ocular corticosteroid implant
- Has significant media opacity precluding evaluation of retina and vitreous in the study eye.
- History of glaucoma or optic nerve head change consistent with glaucoma damage
- History of glaucoma surgery
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 |
|---|---|---|
| IVT afliberceptAlso: EyleaIVT aflibercept [2 mg/0.05 mL] | Drug | Active, Control |
| Sham SCAlso: suprachoroidal shamsham SC | Drug | Control |
| SC CLS-TAAlso: Triamcinolone AcetonideCLS-TA [4 mg/100 μL] SC injection | Drug | Active |
Primary outcome
Mean Change From Baseline in Best Corrected Visual Acuity Letter Score
Time frame: Baseline, 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. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
1 secondary outcome
Mean Change From Baseline in Central Subfield Thickness
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 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 study director
Clearside Biomedical
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IVT aflibercept and SC CLS-TA in people with Diabetic Macular Edema, run by Clearside Biomedical, Inc. at 29 sites in United States.
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 6 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: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 13 May 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?
Mean Change From Baseline in Best Corrected Visual Acuity Letter Score (time frame: Baseline, 6 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 13 May 2021.