Phase 2
N=20
Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema
Diabetic Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT02949024 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events — 8; 9; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IVT Aflibercept (Drug); SC CLS-TA (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Clearside Biomedical, Inc.
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events |
8; 9; 0; 0 | — |
| SECONDARY Mean Change From Baseline in Intraocular Pressure |
14.2; 13.3; -0.3; 2.8 | — |
| SECONDARY Mean Change From Baseline in Central Subfield Thickness |
421.6; 472.7; -90.9; -119.6 | — |
| SECONDARY Best Corrected Visual Acuity |
67.2; 67.2; 8.5; 1.1 | — |
| SECONDARY CLS-TA Injections |
4; 1; 2; 3; 0; 2 | — |
Summary
This study is designed to demonstrate the safety and tolerability of suprachoroidal CLS-TA alone or in combination with intravitreal aflibercept in subjects with diabetic macular edema associated with diabetes mellitus.
Eligibility Criteria
Inclusion Criteria
- Men or women ≥ 18 years of age with type 1 or type 2 diabetes mellitus
- DME with central involvement (>320 microns in the central subfield on SD-OCT) in the study eye
- ETDRS BCVA letter score of 83 to 14, inclusive (Snellen equivalent of 20/25 to 20/500) in the study eye
Exclusion Criteria
- Evidence of DME due to any other cause other than diabetes mellitus in the study eye
- PRP or focal laser photocoagulation in the study eye within 90 days of screening
- Intraocular pressure ≥ 22 mmHg or uncontrolled glaucoma (open angle or angle closure) in the study eye
- History of any previous ophthalmic surgeries in the study eye within 90 days of screening
- High risk PDR in the study eye, for whom enrollment into the study, in the principal investigator's opinion would put the eye at undue risk for vision loss
- Any previous treatment in the study eye with ILUVIEN implant
- Previous treatment for DME in the study eye (TX naive arm only); treatment in the study eye for DME greater than 1 year prior to screening can be considered as treatment naive, at the investigator's discretion
- Subjects previously treated for DME cannot have been treated in the study eye with an intravitreal injection of anti-VEGF or periocular corticosteroids within 90 days prior to screening (Previous TX arm only)
- Subjects previously treated for DME cannot have been treated in the study eye with intraocular corticosteroids within 6 months prior to screening (Previous TX arm only)
Data sourced from ClinicalTrials.gov (NCT02949024). 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.