A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE
Phase 3
Not yet recruiting
- Conditions
- Macular Edema Secondary to Inflammation
- Interventions
- Other: Sham Comparator
- Registration Number
- NCT06996080
- Lead Sponsor
- Kodiak Sciences Inc
- Brief Summary
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Patients with MESI, with a CST of ≥320 and <400 microns on SD-OCT and a BCVA score of ≥25 and ≤78 ETDRS letters (between ~20/25 and 20/320 Snellen equivalent) in the Study Eye at Day 1;
- Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.
Exclusion Criteria
- ME in the Study Eye secondary to diabetes, RVO, or wAMD
- Active or suspected ocular or periocular infection in either eye
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KSI-101 5 mg KSI-101 Intravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing KSI-101 10 mg KSI-101 Intravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing Sham Sham Comparator Sham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing
- Primary Outcome Measures
Name Time Method Mean change in BCVA Week 24 Mean change in BCVA from Day 1 to the average of Week 20 and Week 24.
- Secondary Outcome Measures
Name Time Method