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Clinical trials
catalyst calendar across sponsors →Studies where KOD is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
12 interventional · 6 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTONCT07734844Best corrected visual acuity (BCVA)Randomized · Quadruple-masked · Treatment | Phase 3 | Not yet recruiting | Drug: Tabirafusp tedromer, Aflibercept (2.0 mg) | Diabetic Macular Edema (DME) | 910 | Aug 2028 | ≤ 743 d | 2026-07-29 |
| A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAKNCT06990399Mean change in BCVARandomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: KSI-101 · Other: Sham Comparator | Macular Edema Secondary to Inflammation | 600 | Apr 2027 | ≤ 254 d | 2026-05-18 |
| A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLENCT06996080Mean change in BCVARandomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: KSI-101 · Other: Sham Comparator | Macular Edema Secondary to Inflammation | 300 | Feb 2027 | ≤ 193 d | 2026-05-18 |
| A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAKNCT06556368Best corrected visual acuity (BCVA)Randomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Tarcocimab tedromer, Tabirafusp tedromer, Aflibercept | Wet Age-related Macular Degeneration | 675 | Aug 2026 | ≤ 12 d | 2026-04-29 |
| A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR)NCT06270836Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Tarcocimab · Other: Sham injection | Diabetic Retinopathy | 255 | 2026-02-13actual | — | 2026-05-13 |
| A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)NCT05066230results2024-09-05Percentage of Patients Improving ≥2 Steps on DRSSRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: All patients completed the primary endpoint assessments. Additional follow-up after the primary endpoint was deemed not necessary by the Sponsor. | Drug: KSI-301 · Other: Sham injection | Non-proliferative Diabetic Retinopathy | 253 | 2023-08-03actual | — | 2024-09-05 |
| A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)NCT04611152results2024-08-22Mean Change in BCVARandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Study did not meet primary endpoint | Drug: KSI-301, Aflibercept · Other: Sham Procedure | Diabetic Macular Edema | 460 | 2023-05-11actual | — | 2024-08-22 |
| A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)NCT04603937results2024-08-22Mean Change in BCVARandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Study did not meet primary endpoint | Drug: KSI-301, Aflibercept · Other: Sham Procedure | Diabetic Macular Edema | 459 | 2023-04-27actual | — | 2024-08-22 |
| A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)NCT04964089results2024-05-02Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48.Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: KSI-301, Aflibercept · Other: Sham Procedure | Wet Age-related Macular Degeneration | 557 | 2023-03-28actual | — | 2024-07-03 |
| A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)NCT04592419results2024-06-06Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants.Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: KSI-301, Aflibercept · Other: Sham Procedure | Macular Edema, Retinal Vein Occlusion | 568 | 2022-06-10actual | — | 2024-06-26 |
| A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.NCT04049266results2024-07-18Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48 and 52, Full Analysis Set Year 1Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Terminatedsponsor's stated reason: Primary Endpoint Not Met | Drug: KSI-301, Aflibercept · Other: Sham Procedure | Wet Macular Degeneration | 559 | 2021-11-17actual | — | 2024-07-18 |
| Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVONCT03790852Incidence of ocular (study eye) and systemic adverse eventsRandomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: All patients past planned primary endpoint; decision by Sponsor to wind down open-label follow-up activities. | Drug: KSI-301 | Wet Age-related Macular Degeneration, Retinal Vein Occlusion, Diabetic Macular Edema | 121 | 2021-06-02actual | — | 2024-03-20 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19