Diabetic Macular EdemaPhase 1/2HULKNCT02949024
Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema
A Phase 1/2 study testing IVT Aflibercept and SC CLS-TA in people with Diabetic Macular Edema, run by Clearside Biomedical, Inc. at 2 sites in United States.
Trial summary
This study is designed to demonstrate the safety and tolerability of suprachoroidal CLS-TA alone or in combination with intravitreal aflibercept in subjects with diabetic macular edema associated with diabetes mellitus. 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?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Nov 2016to 17 Oct 2017
- Phase
- Phase 1/2
- 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
- Men or women ≥ 18 years of age with type 1 or type 2 diabetes mellitus
- DME with central involvement (>320 microns in the central subfield on SD-OCT) in the study eye
- ETDRS BCVA letter score of 83 to 14, inclusive (Snellen equivalent of 20/25 to 20/500) in the study eye
Who cannot join
- Evidence of DME due to any other cause other than diabetes mellitus in the study eye
- PRP or focal laser photocoagulation in the study eye within 90 days of screening
- Intraocular pressure ≥ 22 mmHg or uncontrolled glaucoma (open angle or angle closure) in the study eye
- History of any previous ophthalmic surgeries in the study eye within 90 days of screening
- High risk PDR in the study eye, for whom enrollment into the study, in the principal investigator's opinion would put the eye at undue risk for vision loss
- Any previous treatment in the study eye with ILUVIEN implant
Show all 9Show fewer
- Previous treatment for DME in the study eye (TX naive arm only); treatment in the study eye for DME greater than 1 year prior to screening can be considered as treatment naive, at the investigator's discretion
- Subjects previously treated for DME cannot have been treated in the study eye with an intravitreal injection of anti-VEGF or periocular corticosteroids within 90 days prior to screening (Previous TX arm only)
- Subjects previously treated for DME cannot have been treated in the study eye with intraocular corticosteroids within 6 months prior to screening (Previous TX arm only)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Retina Vitreous Associates Medical Group Inc
Mountain View, California, 94040
Retina Consultants of Houston, PA
The Woodlands, Texas, 77384
About this study
Official title: Open-Label Study of the Safety and Efficacy of Suprachoroidal CLS-TA Alone or in Combination With Intravitreal Aflibercept for the Treatment of Diabetic Macular Edema
This study is designed to demonstrate the safety and tolerability of suprachoroidal CLS-TA alone or in combination with intravitreal aflibercept in subjects with diabetic macular edema associated with diabetes mellitus.
Read the detailed description
This is a Phase 1/2, multicenter, open-label study in subject with DME associated with diabetes mellitus.
Subjects will be screened and if eligible, will be assigned to study arm at the Baseline Visit (Visit 1, Day 0).
Following the Baseline Visit, subjects will participate in six monthly follow-up visits (Visit 2-7; Weeks 4-24) for safety and efficacy assessments and to determine whether additional therapy is needed based upon pre-defined criteria.
- Conditions
- Diabetic Macular Edema
- Being tested
- IVT Aflibercept, SC CLS-TA
- Keywords
- Diabetes mellitus, Diabetic retinopathy, Microneedle, Microinjection, 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 Aflibercept
IVT aflibercept [2 mg (50 µL)]
SC CLS-TADrug
Also called Triamcinolone Acetonide
[4 mg (100 µL)]
| Study group | Role | What they receive |
|---|---|---|
| TX Naïve Arm | Experimental | Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye. Receives: Drug: IVT Aflibercept; Drug: SC CLS-TA |
| Previous TX Arm | Experimental | Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA. Receives: Drug: SC CLS-TA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Number of participants with treatment emergent adverse events and serious adverse events reported over 6 months of follow-up
Measured: Over 6 months of follow-up
Secondary outcomes (4)
Mean Change From Baseline in Intraocular Pressure
Baseline and change from baseline at 6 months in intraocular pressure as measured by applanation tonometry
Measured: Baseline and 6 months
Mean Change From Baseline in Central Subfield Thickness
Baseline and change from baseline at 6 months 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 and 6 months
Best Corrected Visual Acuity
Baseline and Change from baseline at 6 months in best corrected visual acuity before and after treatment 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 as the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.
Measured: Baseline and 6 months
CLS-TA Injections
After the initial treatment with CLS-TA, with or without intravitreal aflibercept, at Baseline, retreatment with CLS-TA was allowed in either treatment group from Month 2 through Month 6 if pre-defined retreatment criteria were met. Number of patients receiving 0, 1, 2, 3, 4 or 5 retreatments with CLS-TA.
Measured: 2 to 6 months following initial treatment with study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start10 Nov 2016
- Primary completion17 Oct 2017
- Study completion17 Oct 2017
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT02949024
- Sponsor's protocol ID
- CLS1004-101
- Acronym
- HULK
- Status last verified
- Apr 2021
- First submitted
- 25 Oct 2016
- 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
- Open-Label Study of the Safety and Efficacy of Suprachoroidal CLS-TA Alone or in Combination With Intravitreal Aflibercept for the Treatment of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02949024
- Acronym / sponsor ID
- HULK / CLS1004-101
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetes mellitus, Diabetic retinopathy, Microneedle, Microinjection, Triamcinolone, Choroid, Choroid Injection, Aflibercept
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Clearside Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Posted 19 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 study is designed to demonstrate the safety and tolerability of suprachoroidal CLS-TA alone or in combination with intravitreal aflibercept in subjects with diabetic macular edema associated with diabetes mellitus.
Detailed description
This is a Phase 1/2, multicenter, open-label study in subject with DME associated with diabetes mellitus.
Subjects will be screened and if eligible, will be assigned to study arm at the Baseline Visit (Visit 1, Day 0).
Following the Baseline Visit, subjects will participate in six monthly follow-up visits (Visit 2-7; Weeks 4-24) for safety and efficacy assessments and to determine whether additional therapy is needed based upon pre-defined criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TX Naïve Arm | Experimental | Drug: IVT Aflibercept, Drug: SC CLS-TATreatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye. |
| Previous TX Arm | Experimental | Drug: SC CLS-TATreatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women ≥ 18 years of age with type 1 or type 2 diabetes mellitus
- DME with central involvement (>320 microns in the central subfield on SD-OCT) in the study eye
- ETDRS BCVA letter score of 83 to 14, inclusive (Snellen equivalent of 20/25 to 20/500) in the study eye
Key exclusion criteria (9 listed)
- Evidence of DME due to any other cause other than diabetes mellitus in the study eye
- PRP or focal laser photocoagulation in the study eye within 90 days of screening
- Intraocular pressure ≥ 22 mmHg or uncontrolled glaucoma (open angle or angle closure) in the study eye
- History of any previous ophthalmic surgeries in the study eye within 90 days of screening
- High risk PDR in the study eye, for whom enrollment into the study, in the principal investigator's opinion would put the eye at undue risk for vision loss
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: AfliberceptIVT aflibercept [2 mg (50 µL)] | Drug | TX Naïve Arm |
| SC CLS-TAAlso: Triamcinolone Acetonide[4 mg (100 µL)] | Drug | Previous TX Arm, TX Naïve Arm |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Time frame: Over 6 months of follow-up
Number of participants with treatment emergent adverse events and serious adverse events reported over 6 months of follow-up
4 secondary outcomes
Mean Change From Baseline in Intraocular Pressure
Time frame: Baseline and 6 months
Mean Change From Baseline in Central Subfield Thickness
Time frame: Baseline and 6 months
Best Corrected Visual Acuity
Time frame: Baseline and 6 months
CLS-TA Injections
Time frame: 2 to 6 months following initial treatment with study drug
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 MBA study director
Clearside Biomedical, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IVT Aflibercept and SC CLS-TA in people with Diabetic Macular Edema, run by Clearside Biomedical, Inc. at 2 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 3 inclusion and 9 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 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 19 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?
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events (time frame: Over 6 months of follow-up). 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.