Intravitreal KSI-101 for Swelling of the Retina
(PINNACLE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called KSI-101, an injection for individuals with macular edema, which causes swelling in the part of the eye responsible for clear vision. Researchers aim to determine the effectiveness and safety of KSI-101 for this condition. Participants will receive either the KSI-101 injection or a sham (inactive) injection every four weeks. Suitable candidates have swelling due to eye inflammation not caused by diabetes or other specific eye issues. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.
Do I need to stop my current medications for the 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 was well tolerated in earlier studies. Patients who received KSI-101 generally did not encounter major safety issues. In a follow-up study, KSI-101 continued to perform well, with most patients not experiencing serious side effects. This suggests that KSI-101 may be safe for humans. However, as with any treatment, participants should discuss possible risks with their healthcare provider.12345
Why are researchers excited about this trial's treatments?
Unlike the standard treatments for retinal swelling, which often involve repeated injections of anti-VEGF agents like ranibizumab or aflibercept, KSI-101 offers a unique approach. KSI-101 is a novel intravitreal injection designed to deliver its medication directly into the eye, potentially reducing the frequency of treatments required over time. Researchers are particularly excited about KSI-101 because it combines two different molecular approaches into one treatment, potentially enhancing its effectiveness and duration of action compared to existing options. This could mean fewer office visits and a more convenient treatment schedule for patients suffering from retinal swelling.
What evidence suggests that this trial's treatments could be effective for macular edema?
Research has shown that KSI-101 holds promise for treating macular edema, which is swelling in the eye due to inflammation. In earlier studies, over 90% of patients experienced a reduction in this swelling. In this trial, participants will receive either the 5 mg or 10 mg dose of KSI-101, both of which have cleared fluid buildup in the eye, a key sign of swelling. This suggests that KSI-101 could greatly improve vision by reducing eye swelling and could be an effective option for managing macular edema.12367
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 specific thickness of the retina and vision acuity within certain limits. Those with macular edema caused by diabetes, retinal vein occlusion (RVO), or age-related macular degeneration (wAMD) cannot join.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 for treating macular edema secondary to inflammation. It's compared against a sham procedure to assess its effectiveness and safety in improving vision and reducing retinal swelling.
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 ...
6.
ir.kodiak.com
ir.kodiak.com/news-releases/news-release-details/new-data-kodiaks-ksi-101-apex-study-reinforce-its-clinicallyNew data for Kodiak's KSI-101 from the APEX study reinforce ...
"The APEX data with KSI-101 bispecific antibody showed a drying effect that is on par with or even better than expected with the intraocular ...
7.
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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