At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 71 enrolled
Drug / intervention
IVT aflibercept +2 moredrug
Likely dose
IVT aflibercept 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating IVT aflibercept, Sham SC, and 1 other intervention for Diabetic Macular Edema. Completed, enrolled 71 participants across 29 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartJul 2017
Primary CompletionApr 2018
TodayJul 2026
First PostedApr 24, 2017
Enrollment StartJul 11, 2017
Primary CompletionApr 17, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.2 years ago
Interventions
IVT afliberceptdrug
IVT aflibercept \[2 mg/0.05 mL\]
Sham SCdrug
sham SC
SC CLS-TAdrug
CLS-TA \[4 mg/100 μL\] SC injection