search
Back to results

Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema (HULK)

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IVT Aflibercept
SC CLS-TA
Sponsored by
Clearside Biomedical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetes mellitus, Diabetic retinopathy, Microneedle, Microinjection, Triamcinolone, Choroid, Choroid Injection, Aflibercept, Suprachoroidal, Triamcinolone acetonide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)

Sites / Locations

  • Retina Vitreous Associates Medical Group Inc
  • Retina Consultants of Houston, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TX Naïve Arm

Previous TX Arm

Arm Description

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.

Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean Change From Baseline in Intraocular Pressure
Baseline and change from baseline at 6 months in intraocular pressure as measured by applanation tonometry
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.
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.
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.

Full Information

First Posted
October 25, 2016
Last Updated
April 22, 2021
Sponsor
Clearside Biomedical, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02949024
Brief Title
Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema
Acronym
HULK
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 10, 2016 (Actual)
Primary Completion Date
October 17, 2017 (Actual)
Study Completion Date
October 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clearside Biomedical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetes mellitus, Diabetic retinopathy, Microneedle, Microinjection, Triamcinolone, Choroid, Choroid Injection, Aflibercept, Suprachoroidal, Triamcinolone acetonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TX Naïve Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Previous TX Arm
Arm Type
Experimental
Arm Description
Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.
Intervention Type
Drug
Intervention Name(s)
IVT Aflibercept
Other Intervention Name(s)
Aflibercept
Intervention Description
IVT aflibercept [2 mg (50 µL)]
Intervention Type
Drug
Intervention Name(s)
SC CLS-TA
Other Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
[4 mg (100 µL)]
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Description
Number of participants with treatment emergent adverse events and serious adverse events reported over 6 months of follow-up
Time Frame
Over 6 months of follow-up
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Intraocular Pressure
Description
Baseline and change from baseline at 6 months in intraocular pressure as measured by applanation tonometry
Time Frame
Baseline and 6 months
Title
Mean Change From Baseline in Central Subfield Thickness
Description
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.
Time Frame
Baseline and 6 months
Title
Best Corrected Visual Acuity
Description
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.
Time Frame
Baseline and 6 months
Title
CLS-TA Injections
Description
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.
Time Frame
2 to 6 months following initial treatment with study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Ciulla, MD MBA
Organizational Affiliation
Clearside Biomedical, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Retina Vitreous Associates Medical Group Inc
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Retina Consultants of Houston, PA
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema

We'll reach out to this number within 24 hrs