Intravitreal KSI-101 for Swelling of the Retina
(PEAK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new eye treatment called KSI-101, an experimental drug, to evaluate its effectiveness and safety for people with macular edema, a condition involving swelling in the retina due to inflammation. Participants will receive varying doses of KSI-101 or a sham (fake) injection for comparison. It suits individuals diagnosed with macular edema from inflammation who have vision problems, such as seeing between 20/40 and 20/320 on a vision chart. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that KSI-101 is generally safe for patients. In earlier studies, most participants taking higher doses experienced good results without major issues. No reports of serious side effects led to discontinuation of the treatment, indicating that KSI-101 is usually well-tolerated. As this is a Phase 3 trial, earlier phases found the treatment safe enough for further testing. However, like any medical treatment, some individuals might experience mild side effects. Participants should always consult the study team or their doctor with any concerns.12345
Why do researchers think this study treatment might be promising for macular edema?
Researchers are excited about KSI-101 for treating retinal swelling because it offers a new approach compared to current treatments like anti-VEGF injections. KSI-101 is designed to be administered as an intravitreal injection, similar to existing therapies, but it potentially allows for more individualized dosing after an initial treatment period. This could mean fewer injections over time, which is a big plus for patients. Additionally, the two different doses being tested (5 mg and 10 mg) may provide options for tailoring treatment to the severity of the condition, offering more personalized care.
What evidence suggests that KSI-101 could be an effective treatment for macular edema?
Research has shown that KSI-101 works well in treating macular edema caused by inflammation. In earlier studies, more than 90% of patients using KSI-101 experienced no fluid buildup in their retina, reducing swelling and improving vision. This trial will test KSI-101 at different doses, with participants receiving either a 5 mg or 10 mg dose. These findings suggest that KSI-101 could be a promising option for effectively managing retinal swelling.14678
Who Is on the Research Team?
Pablo Velazquez-Martin, MD
Principal Investigator
Kodiak Sciences Inc
Are You a Good Fit for This Trial?
This trial is for individuals with macular edema, which is swelling in the central part of the retina, due to inflammation. Participants must have a certain level of retinal thickness and vision range (20/40 to 20/320). They should also have non-infectious intraocular inflammation in one eye, whether it's currently active or not.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravitreal injections of KSI-101 or sham every 4 weeks for 6 months, followed by individualized dosing
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KSI-101
Trial Overview
The study tests KSI-101, an intravitreal injection directly into the eye compared to a sham procedure. It aims to see if KSI-101 can effectively reduce swelling and improve vision without causing harm.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Intravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing
Intravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing
Sham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kodiak Sciences Inc
Lead Sponsor
Citations
1.
ir.kodiak.com
ir.kodiak.com/news-releases/news-release-details/follow-data-kodiaks-ksi-101-apex-study-showed-continuedFollow-up data for Kodiak's KSI-101 from the APEX study ...
Follow-up data for Kodiak's KSI-101 from the APEX study showed continued strengthening of clinical effect (≥90% of patients achieving absence of ...
Follow-up data for Kodiak's KSI-101 from the APEX study ...
Follow-up data for Kodiak's KSI-101 from the APEX study showed continued strengthening of clinical effect (≥90% of patients achieving absence of ...
Kodiak reports follow-up outcomes from APEX study of KSI- ...
In the study, more than 90% of subjects achieved absence of intraretinal and subretinal fluid. Go deeper with GlobalData. ReportsLogo. Reports ...
NCT06996080 | A Phase 3 Study to Evaluate the Efficacy ...
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI). Official ...
5.
marketchameleon.com
marketchameleon.com/articles/b/2025/11/5/kodiak-ksi-101-achieves-90-percent-retinal-dryness-week-20-mesi-studyKodiak's KSI-101 Shows 90% Success Rate in Achieving ...
An outstanding 90% of patients in the 5 mg and 10 mg dose groups achieved and sustained the absence of both intraretinal and subretinal fluid—a ...
Efficacy and safety of intravitreal anti-VEGF therapy in diabetic ...
This review includes a brief overview of the efficacy and safety of currently available (bevacizumab, ranibizumab, and aflibercept) and potential future ( ...
Kodiak Sciences Data at ARVO 2025 Highlight Power and ...
To inform and support further clinical development of KSI-101, which has demonstrated a positive safety profile in patients, here we demonstrate ...
8.
ctv.veeva.com
ctv.veeva.com/study/a-phase-3-study-to-evaluate-the-efficacy-and-safety-of-intravitreal-ksi-101-in-participants-with-macA Phase 3 Study to Evaluate the Efficacy and Safety of ...
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI).
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