Skip to main content
OpenTrials
Completed

NCT Number: NCT03126786

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.

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 2

Primary location

Retinal Consultants of Arizona and Retinal Research Institute, Phoenix, Arizona, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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")

Treatment and study plan

IVT aflibercept

Drug

IVT aflibercept [2 mg/0.05 mL]

Other names: Eylea

Sham SC

Drug

sham SC

Other names: suprachoroidal sham

SC CLS-TA

Drug

CLS-TA [4 mg/100 μL] SC injection

Other names: Triamcinolone Acetonide

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean Change From Baseline in Central Subfield Thickness

    Time frame: Baseline, 6 months

    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.

Sponsors and collaborators

Lead sponsor

Clearside Biomedical, Inc.

Industry

Registry information

Official study 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

Acronym: TYBEE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 24, 2017
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.