Phase 2 N=46 Randomized Triple-blind Treatment

Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO

Macular Edema · Retinal Vein Occlusion

Bottom Line

View on ClinicalTrials.gov: NCT02303184 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm — 18; 7; 3; 12 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 4 mg CLS-TA (Drug); Sham (Drug); IVT aflibercept (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Clearside Biomedical, Inc.
Primary completion: Mar 2016

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	—

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).

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

View full record on ClinicalTrials.gov →

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.