Phase 2
Completed N=46
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
Source: ClinicalTrials.gov NCT02303184 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm — 18; 7; 3; 12 Participants
Summary
A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm |
18; 7; 3; 12; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosis of macular edema following RVO
- History of ME ≤ 12 months
- 20-70 letters inclusive BCVA using ETDRS
Exclusion Criteria
- has had an IVT injection of anti-VEGF for RVO in the study eye
- has had a corticosteroid injection in the past 3 months in the study eye
- any uncontrolled ophthalmic condition in the study eye other than RVO
Data sourced from ClinicalTrials.gov (NCT02303184). 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.