Macular Edema Secondary to Inflammation
Conditions
Keywords
MESI, macular edema, inflammatory macular edema, macular edema associated with inflammation
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)
Interventions
DRUGKSI-101
Intravitreal injection
OTHERSham Comparator
Sham injections
Sponsors
Kodiak Sciences Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Macular Edema Secondary to Inflammation (MESI) with a central subfield thickness (CST) of ≥400 microns on SD-OCT in Study Eye. * Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT in the Study Eye. * BCVA ETDRS score of ≥25 and ≤70 letters (between 20/40 and 20/320 Snellen equivalent) in the Study Eye. * Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.
Exclusion criteria
* Macular Edema in the Study Eye secondary to diabetic retinopathy, RVO, or wAMD. * Active or suspected ocular or periocular infection in either eye. * Any history of or active occlusive retinal vasculitis in either eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in BCVA | Week 24 | Mean change in BCVA from Day 1 to the average of Week 20 and Week 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with BCVA improvement | Baseline to 24 weeks | The proportion of participants in whom BCVA had improved by ≥15 letters from baseline to 24 weeks. |
Countries
Puerto Rico, United States
Contacts
CONTACTKodiak Sciences Inc
STUDY_DIRECTORPablo Velazquez-Martin, MD
Kodiak Sciences Inc
Outcome results
None listed