Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema (TYBEE)

Clearside Biomedical

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: SC CLS-TA; Drug: IVT aflibercept; Drug: Sham SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03126786

CLS1004-201

Details and patient eligibility

About

The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA used with intravitreal aflibercept in subjects with DME.

Full 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).

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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")

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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71 participants in 2 patient groups

Active

Active Comparator group

Description:

Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA

Treatment:

Drug: IVT aflibercept

Drug: SC CLS-TA

Control

Sham Comparator group

Description:

Treatment will consist of IVT aflibercept injection followed by a sham SC procedure

Treatment:

Drug: IVT aflibercept

Drug: Sham SC