A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KSI-101, Sham Comparator.
- Who it may be relevant to
- Registry conditions: Macular Edema Secondary to Inflammation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Puerto Rico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-masked, Sham-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tabirafusp Alfa (KSI-101) in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK
Overview
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)
Interventions
- Drug KSI-101
Intravitreal injection - Other Sham Comparator
Sham injections
Primary outcome measures
- Mean change in BCVA [Time frame: Week 24]
Secondary outcome measures (1)
- Proportion of participants with BCVA improvement [Time frame: Baseline to 24 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 55 centers
- AZ Retina & Vitreous Consultants — Phoenix
- Research Network Arizona — Scottsdale
- California Retina Consultants (Bakersfield) — Bakersfield
- Global Research Management, Inc. — Glendale
- UCSD/Jacobs Retina Center — La Jolla
- UCLA Stein Eye Institute — Los Angeles
- California Retina Consultants (Oxnard) — Oxnard
- Stanford Byers Eye Institute — Palo Alto
- … and 47 more centers
Puerto Rico · 1 center
- Centro Oftalmologico Metropolitano — San Juan
Identifiers
NCT: NCT06990399 · KSMP001-S1