Intravitreal KSI-101 for macular edema caused by inflammation (PINNACLE)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, randomized interventional study comparing intravitreal KSI-101 injections to a sham procedure in participants with macular edema secondary to non-infectious intraocular inflammation. Eligible participants must meet optical coherence tomography (OCT) and visual acuity thresholds and will be followed with OCT imaging and standardized visual acuity testing. The study will monitor both efficacy outcomes related to retinal thickness and vision and safety outcomes related to ocular and systemic adverse events. Results will compare changes in central subfield thickness and best-corrected visual acuity between the KSI-101 and sham groups over the study period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• AZ Retina & Vitreous Consultants
  Phoenix, Arizona, United States Recruiting
• Research Network Arizona
  Scottsdale, Arizona, United States Recruiting
• California Retina Consultants (Bakersfield)
  Bakersfield, California, United States Recruiting
• Global Research Management, Inc.
  Glendale, California, United States Recruiting
• UCSD/Jacobs Retina Center
  La Jolla, California, United States Recruiting
• UCLA Stein Eye Institute
  Los Angeles, California, United States Recruiting

+6 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Kodiak Sciences Inc
• Email: ClinicalTrials@kodiak.com
• Phone: (650) 281-0850

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intravitreal KSI-101 for macular edema due to inflammation (PEAK)

  This trial will test whether injections of KSI-101 can reduce retinal swelling and improve vision in adults with macular edema caused by non-infectious inflammation.

  Recruiting at 49 sites Phase 3 Kodiak Sciences Inc · Phoenix, Arizona and 55 other locations · NCT06990399

• Tabirafusp Tedromer vs Aflibercept for Diabetic Macular Edema (DME)

  This study tests whether Tabirafusp Tedromer can work as well as or better than Aflibercept to help people with Diabetic Macular Edema.

  Recruiting at 52 sites Phase 3 Kodiak Sciences Inc · Scottsdale, Arizona and 51 other locations · NCT07734844

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.