Skip to main content
OpenTrials
Completed

NCT Number: NCT02949024

Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Macular Edema Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Retina Vitreous Associates Medical Group Inc, Mountain View, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IVT aflibercept

Drug

IVT aflibercept [2 mg (50 µL)]

Other names: Aflibercept

SC CLS-TA

Drug

[4 mg (100 µL)]

Other names: Triamcinolone Acetonide

Primary outcomes

  1. 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

Secondary outcomes

  1. Mean Change From Baseline in Intraocular Pressure

    Time frame: Baseline and 6 months

    Baseline and change from baseline at 6 months in intraocular pressure as measured by applanation tonometry

  2. Mean Change From Baseline in Central Subfield Thickness

    Time frame: Baseline and 6 months

    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.

  3. Best Corrected Visual Acuity

    Time frame: Baseline and 6 months

    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.

  4. CLS-TA Injections

    Time frame: 2 to 6 months following initial treatment with study drug

    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.

Sponsors and collaborators

Lead sponsor

Clearside Biomedical, Inc.

Industry

Registry information

Official study 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

Acronym: HULK

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2016
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.