Macular Edema Secondary to InflammationPhase 3PINNACLENCT06996080
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE
A Phase 3 study testing KSI-101 in people with Macular Edema Secondary to Inflammation, run by Kodiak Sciences Inc at 56 sites in 2 countries.
Trial summary
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema Secondary to Inflammation
- What is being tested?
- KSI-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 56 sitesin 2 countries
- Study dates
- 16 Jul 2025to Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Macular Edema Secondary to Inflammation (MESI) with a central subfield thickness (CST) of ≥320 and <400 microns on SD-OCT and a BCVA score of ≥25 and ≤78 ETDRS letters (between ~20/25 and 20/320 Snellen equivalent) in the Study Eye.
- Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT in the Study Eye.
- Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.
Who cannot join
- ME in the Study Eye secondary to diabetes, RVO, or wAMD.
- Active or suspected ocular or periocular infection in either eye.
- Any history of or active occlusive retinal vasculitis in either eye.
Trial locations and contacts
56 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
56 sites in 2 countries
United States55 sites, 53 recruiting
- Recruiting
Retina Research Institute of Texas
Abilene, Texas, 79606
- Not yet recruiting
Eye Associates of New Mexico, Vision Research Center
Albuquerque, New Mexico, 87109
- Not yet recruiting
Florida Eye Clinic
Altamonte Springs, Florida, 32701
- Recruiting
Austin Retina Associates, PLLC (Austin)
Austin, Texas, 78705
- Not yet recruiting
UT Austin
Austin, Texas, 78712
- Recruiting
California Retina Consultants (Bakersfield)
Bakersfield, California, 93309
- Recruiting
Retina Consultants of Texas (Bellaire)
Bellaire, Texas, 77401
- Recruiting
Pacific Northwest Retina (Bellevue)
Bellevue, Washington, 98004
- Recruiting
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
- Recruiting
Associated Vitreoretinal and Uveitis Consultants LLC
Carmel, Indiana, 46032
- Recruiting
Midwest Eye Institute
Carmel, Indiana, 46032
- Recruiting
North Carolina Retina Associates (Cary)
Cary, North Carolina, 27511
- Recruiting
Charleston Neuroscience Institute, LLC (Charleston)
Charleston, South Carolina, 29414
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
Ohio State University
Columbus, Ohio, 43212
- Withdrawn
Retina Specialists of Colorado (RSC)
Denver, Colorado, 80222
- Recruiting
Rocky Mountain Uveitis
Denver, Colorado, 80246
- Recruiting
Retina Associates, LTD
Elmhurst, Illinois, 60126
- Recruiting
Erie Retina Research
Erie, Pennsylvania, 16507
- Recruiting
Retina Group of Florida (Ft. Lauderdale)
Fort Lauderdale, Florida, 33308
- Recruiting
Global Research Management, Inc.
Glendale, California, 91204
- Recruiting
Coastal Eye Surgeons
Greenwich, Connecticut, 06830
- Recruiting
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
- Recruiting
Texas Retina Center
Houston, Texas, 77030
- Recruiting
Retina Consultants of Texas (Katy)
Katy, Texas, 77494
- Recruiting
UCSD/Jacobs Retina Center
La Jolla, California, 92093
- Recruiting
UCLA Stein Eye Institute
Los Angeles, California, 90095
- Recruiting
Retina Consultants, PC
Manchester, Connecticut, 06042
- Recruiting
Tennessee Retina PC
Nashville, Tennessee, 37203
- Recruiting
Vanderbilt Eye Institute
Nashville, Tennessee, 37232
- Recruiting
Retina Associates of New York, P.C.
New York, New York, 10075
- Recruiting
California Retina Consultants (Oxnard)
Oxnard, California, 93036
- Recruiting
St. Mary's Eye Surgery Center (Metropolitan Eye Research and Surgery Institute)
Palisades Park, New Jersey, 07650
- Not yet recruiting
Stanford Byers Eye Institute
Palo Alto, California, 94303
- Recruiting
California Eye Specialists Medical Group, Inc.
Pasadena, California, 91107
- Withdrawn
Vision Research Solutions
Philadelphia, Pennsylvania, 19141
- Recruiting
AZ Retina & Vitreous Consultants
Phoenix, Arizona, 85016
- Recruiting
Texas Retina Associates (Plano)
Plano, Texas, 75075
- Recruiting
California Eye Specialists Medical Group, Inc.
Redlands, California, 92373
- Recruiting
Retina Consultants of Southern California
Redlands, California, 92374
- Recruiting
Austin Retina Associates, PLLC (Round Rock)
Round Rock, Texas, 78681
- Recruiting
Retinal Consultants Medical Group Inc
Sacramento, California, 95841
- Recruiting
Retina Consultants of Minnesota
Saint Louis Park, Minnesota, 55416
- Recruiting
Retina Consultants of Texas (San Antonio)
San Antonio, Texas, 78240
- Recruiting
Research Network Arizona
Scottsdale, Arizona, 85255
- Recruiting
Pacific Northwest Retina (Silverdale)
Silverdale, Washington, 98383
- Recruiting
Ophthalmology Ltd
Sioux Falls, South Dakota, 57108
- Recruiting
Cascade Medical Research Institute
Springfield, Oregon, 97477
- Recruiting
The Retina Institute
St Louis, Missouri, 63128
- Recruiting
Retina Vitreous Associates of Florida (St. Petersburg)
St. Petersburg, Florida, 33711
- Recruiting
Retina Consultants of Texas (Woodlands)
The Woodlands, Texas, 77384
- Recruiting
North Carolina Retina Associates (Wake Forest)
Wake Forest, North Carolina, 27587
- Recruiting
Retina Group of New England, PC
Waterford, Connecticut, 06385
- Recruiting
Eye Clinic of Wisconsin
Wausau, Wisconsin, 54403
- Recruiting
Palmetto Retina Center (West Columbia)
West Columbia, South Carolina, 29169
Puerto Rico1 site, 1 recruiting
- Recruiting
Centro Oftalmologico Metropolitano
San Juan, 00921
About this study
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) - PINNACLE
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)
- Conditions
- Macular Edema Secondary to Inflammation
- Being tested
- KSI-101, Sham Comparator
- Keywords
- MESI, macular edema, inflammatory macular edema, macular edema associated with inflammation
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSI-101Drug
Also called tabirafusp alfa
Intravitreal injection
Sham ComparatorOther
Sham injections
| Study group | Role | What they receive |
|---|---|---|
| KSI-101 5 mg | Experimental | Intravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing Receives: Drug: KSI-101 |
| KSI-101 10 mg | Experimental | Intravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing Receives: Drug: KSI-101 |
| Sham | Sham comparator | Sham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing Receives: Other: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in BCVA
Mean change in BCVA from Day 1 to the average of Week 20 and Week 24.
Measured: Week 24
Secondary outcomes (1)
Proportion of participants with BCVA improvement
The proportion of participants in whom BCVA had improved by ≥15 letters from baseline to 24 weeks.
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start16 Jul 2025
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Edema Secondary to InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kodiak Sciences Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996080
- Sponsor's protocol ID
- KSMP001-S2
- Acronym
- PINNACLE
- Status last verified
- May 2026
- First submitted
- 21 May 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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) - PINNACLE
- ClinicalTrials.gov ID
- NCT06996080
- Acronym / sponsor ID
- PINNACLE / KSMP001-S2
- Conditions
- Macular Edema Secondary to Inflammation
- Keywords
- MESI, macular edema, inflammatory macular edema, macular edema associated with inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kodiak Sciences IncIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KSI-101 5 mg | Experimental | Drug: KSI-101Intravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing |
| KSI-101 10 mg | Experimental | Drug: KSI-101Intravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing |
| Sham | Sham comparator | Other: Sham ComparatorSham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Macular Edema Secondary to Inflammation (MESI) with a central subfield thickness (CST) of ≥320 and <400 microns on SD-OCT and a BCVA score of ≥25 and ≤78 ETDRS letters (between ~20/25 and 20/320 Snellen equivalent) in the Study Eye.
- Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT in the Study Eye.
- Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.
Key exclusion criteria (3 listed)
- ME in the Study Eye secondary to diabetes, RVO, or wAMD.
- Active or suspected ocular or periocular infection in either eye.
- Any history of or active occlusive retinal vasculitis in either eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KSI-101Also: tabirafusp alfaIntravitreal injection | Drug | KSI-101 10 mg, KSI-101 5 mg |
| Sham ComparatorSham injections | Other | Sham |
Primary outcome
Mean change in BCVA
Time frame: Week 24
Mean change in BCVA from Day 1 to the average of Week 20 and Week 24.
1 secondary outcome
Proportion of participants with BCVA improvement
Time frame: Baseline to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
Related trials for Macular Edema Secondary to Inflammation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
56 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KSI-101 in people with Macular Edema Secondary to Inflammation, run by Kodiak Sciences Inc at 56 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kodiak Sciences Inc ((650) 281-0850, ClinicalTrials@kodiak.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in BCVA (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.