Phase 3
N=557
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)
Wet Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT04964089 ↗Enrolled (actual)
557
Serious AEs
14.0%
Results posted
May 2024
Primary outcome: Primary: Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48. — 2.5; 4.6 ETDRS Letters — p=0.0083
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- KSI-301 (Drug); Aflibercept (Drug); Sham Procedure (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Kodiak Sciences Inc
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48. |
2.5; 4.6 | 0.0083 sig |
| SECONDARY Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time |
2.8; 2.9; 3.4; 4.2; 3.7; 5.1 | — |
| SECONDARY Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time |
100; 96; 110; 129; 119; 151 | — |
| SECONDARY Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time |
20; 28; 27; 19; 41; 22 | — |
| SECONDARY Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) |
122; 129; 148; 152; 156; 165 | — |
| SECONDARY Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) |
17; 15; 11; 12; 10; 14 | — |
| SECONDARY Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time |
-72.1; -99.9; -74.9; -109.4; -89.1; -122.2 | — |
Summary
This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)
Eligibility Criteria
Inclusion Criteria
- Signed informed consent prior to participation in the study.
- Treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
- BCVA ETDRS score between 83 and 25 letters, inclusive, in the Study Eye.
- Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wAMD.
- Other protocol-specified inclusion criteria may apply
Exclusion Criteria
- BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular).
- Active or suspected ocular or periocular infection or inflammation.
- CNV secondary to other causes in the Study Eye.
- Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study.
- Uncontrolled glaucoma in the Study Eye.
- Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT or fundus photography.
- Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening.
- Women who are pregnant or lactating or intending to become pregnant during the study.
- Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
- History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
- Uncontrolled blood pressure defined as a systolic value ≥180 mmHg or diastolic value ≥100 mmHg while at rest.
- Other protocol-specified exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT04964089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.