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
Overview
- Phase
- Phase 2
- Intervention
- IVT aflibercept
- Conditions
- Diabetic Macular Edema
- Sponsor
- Clearside Biomedical, Inc.
- Enrollment
- 71
- Locations
- 29
- Primary Endpoint
- Mean Change From Baseline in Best Corrected Visual Acuity Letter Score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA used with intravitreal aflibercept in subjects with DME.
Detailed 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).
Investigators
Eligibility Criteria
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")
Arms & Interventions
Active
Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA
Intervention: IVT aflibercept
Active
Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA
Intervention: SC CLS-TA
Control
Treatment will consist of IVT aflibercept injection followed by a sham SC procedure
Intervention: IVT aflibercept
Control
Treatment will consist of IVT aflibercept injection followed by a sham SC procedure
Intervention: Sham SC
Outcomes
Primary Outcomes
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
- Mean Change From Baseline in Central Subfield Thickness(Baseline, 6 months)