Phase 2 N=71 Randomized Quadruple-blind Treatment

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

Diabetic Macular Edema

Bottom Line

View on ClinicalTrials.gov: NCT03126786 ↗

Enrolled (actual)

Serious AEs

14.1%

Results posted

May 2021

Primary outcome: Primary: Mean Change From Baseline in Best Corrected Visual Acuity Letter Score — 11.4; 13.8 letters — p=0.288

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: IVT aflibercept (Drug); Sham SC (Drug); SC CLS-TA (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Clearside Biomedical, Inc.
Primary completion: Apr 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Best Corrected Visual Acuity Letter Score	11.4; 13.8	0.288
SECONDARY Mean Change From Baseline in Central Subfield Thickness	-212.1; -178.6	—

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.

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")

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03126786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.