NCT06990399 A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK
| NCT ID | NCT06990399 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Kodiak Sciences Inc |
| Condition | Macular Edema Secondary to Inflammation |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 600 participants in total. It began in 2025-07-30 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
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.
Contact & Investigator
Pablo Velazquez-Martin, MD
STUDY DIRECTOR
Kodiak Sciences Inc
Frequently Asked Questions
Who can join the NCT06990399 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Macular Edema Secondary to Inflammation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06990399 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 600 participants.
Is NCT06990399 currently recruiting?
Yes, NCT06990399 is actively recruiting participants. Contact the research team at ClinicalTrials@kodiak.com for enrollment information.
Where is the NCT06990399 trial being conducted?
This trial is being conducted at Phoenix, United States, Scottsdale, United States, Bakersfield, United States, Glendale, United States and 11 additional locations.
Who is sponsoring the NCT06990399 clinical trial?
NCT06990399 is sponsored by Kodiak Sciences Inc. The principal investigator is Pablo Velazquez-Martin, MD at Kodiak Sciences Inc. The trial plans to enroll 600 participants.