Phase 2
Completed N=71
Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema
Source: ClinicalTrials.gov NCT03126786 ↗Enrolled (actual)
71
Serious AEs
14.1%
Results posted
May 2021
Primary outcomePrimary: Mean Change From Baseline in Best Corrected Visual Acuity Letter Score — 11.4; 13.8 letters — p=0.288
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.
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 | — |
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")
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. Informational only — not medical advice.