Intravitreal KSI-101 for Swelling of the Retina

(PEAK Trial)

Recruiting at 32 trial locations

Overseen By Kodiak Sciences Inc

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Kodiak Sciences Inc

Disqualifiers: Diabetes, RVO, wAMD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

150 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 4 6 7 8}

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

MESI with a central subfield thickness (CST) of ≥400 microns on SD-OCT in Study Eye

BCVA ETDRS score of ≥25 and ≤70 letters (between 20/40 and 20/320 Snellen equivalent) in the Study Eye

I have inflammation in my eye that is not caused by an infection.

Exclusion Criteria

My eye condition is due to diabetes, blocked veins, or age-related issues.

I suspect or have been diagnosed with an eye infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravitreal injections of KSI-101 or sham every 4 weeks for 6 months, followed by individualized dosing

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: KSI-101 5 mg Experimental Treatment 1 Intervention

Intravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing

Group II: KSI-101 10 mg Experimental Treatment 1 Intervention

Intravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing

Group III: Sham Placebo Group 1 Intervention

Sham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing

Who Is Running the Clinical Trial?

Kodiak Sciences Inc

Lead Sponsor

Trials

9

Recruited

3,900+

Citations

1. ir.kodiak.com ir.kodiak.com/news-releases/news-release-details/follow-data-kodiaks-ksi-101-apex-study-showed-continued

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 ...

2. prnewswire.com prnewswire.com/news-releases/follow-up-data-for-kodiaks-ksi-101-from-the-apex-study-showed-continued-strengthening-of-clinical-effect-90-of-patients-achieving-absence-of-intraretinal-and-subretinal-fluid-through-week-20-in-macular-edema-secondary-to-infl-302605063.html

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 ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/kodiak-outcomes-apex-study-ksi101/

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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06996080

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-study

Kodiak'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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10863998/

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 ( ...

7. firstwordpharma.com firstwordpharma.com/story/5956091

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-mac

A 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).