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)
CompletedPhase 3Results postedLast updated 3 July 2024
What this trial tests
Phase 3 trial testing KSI-301 in Wet Age-related Macular Degeneration in 557 participants. Completed in 6 April 2023.
50 and older, any sex, with Wet Age-related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.Primary· Day 1 to Week 48
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Group
Value
95% CI
KSI-301 (Treatment Group A)
2.5
± 0.78
Aflibercept (Treatment Group B)
4.6
± 0.76
Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over TimeSecondary· Day 1 to Week 48
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Week 2
Group
Value
95% CI
KSI-301 (Treatment Group A)
2.8
± 6.48
Aflibercept (Treatment Group B)
2.9
± 7.12
Week 4
Group
Value
95% CI
KSI-301 (Treatment Group A)
3.4
± 7.05
Aflibercept (Treatment Group B)
4.2
± 7.29
Week 8
Group
Value
95% CI
KSI-301 (Treatment Group A)
3.7
± 8.52
Aflibercept (Treatment Group B)
5.1
± 7.86
Week 12
Group
Value
95% CI
KSI-301 (Treatment Group A)
3.8
± 8.83
Aflibercept (Treatment Group B)
5.4
± 7.90
Week 16
Group
Value
95% CI
KSI-301 (Treatment Group A)
3.6
± 9.09
Aflibercept (Treatment Group B)
4.9
± 8.54
Week 20
Group
Value
95% CI
KSI-301 (Treatment Group A)
3.9
± 9.60
Aflibercept (Treatment Group B)
5.7
± 8.97
Week 24
Group
Value
95% CI
KSI-301 (Treatment Group A)
4.5
± 9.29
Aflibercept (Treatment Group B)
6.0
± 9.45
Week 28
Group
Value
95% CI
KSI-301 (Treatment Group A)
4.5
± 9.75
Aflibercept (Treatment Group B)
6.1
± 9.49
Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over TimeSecondary· Day 1 to Week 48
Categorical improvements in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart
Gain ≥5 ETDRS Letters at Week 2
Group
Value
95% CI
KSI-301 (Treatment Group A)
100
Aflibercept (Treatment Group B)
96
Gain ≥5 ETDRS Letters at Week 4
Group
Value
95% CI
KSI-301 (Treatment Group A)
110
Aflibercept (Treatment Group B)
129
Gain ≥5 ETDRS Letters at Week 8
Group
Value
95% CI
KSI-301 (Treatment Group A)
119
Aflibercept (Treatment Group B)
151
Gain ≥5 ETDRS Letters at Week 12
Group
Value
95% CI
KSI-301 (Treatment Group A)
124
Aflibercept (Treatment Group B)
148
Gain ≥5 ETDRS Letters at Week 16
Group
Value
95% CI
KSI-301 (Treatment Group A)
119
Aflibercept (Treatment Group B)
143
Gain ≥5 ETDRS Letters at Week 20
Group
Value
95% CI
KSI-301 (Treatment Group A)
121
Aflibercept (Treatment Group B)
161
Gain ≥5 ETDRS Letters at Week 24
Group
Value
95% CI
KSI-301 (Treatment Group A)
130
Aflibercept (Treatment Group B)
156
Gain ≥5 ETDRS Letters at Week 28
Group
Value
95% CI
KSI-301 (Treatment Group A)
122
Aflibercept (Treatment Group B)
154
Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over TimeSecondary· Day 1 to Week 48
Categorical worsening in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart
Loss ≥ 5 ETDRS Letters at Week 2
Group
Value
95% CI
KSI-301 (Treatment Group A)
20
Aflibercept (Treatment Group B)
28
Loss ≥ 5 ETDRS Letters at Week 4
Group
Value
95% CI
KSI-301 (Treatment Group A)
27
Aflibercept (Treatment Group B)
19
Loss ≥ 5 ETDRS Letters at Week 8
Group
Value
95% CI
KSI-301 (Treatment Group A)
41
Aflibercept (Treatment Group B)
22
Loss ≥ 5 ETDRS Letters at Week 12
Group
Value
95% CI
KSI-301 (Treatment Group A)
35
Aflibercept (Treatment Group B)
24
Loss ≥ 5 ETDRS Letters at Week 16
Group
Value
95% CI
KSI-301 (Treatment Group A)
35
Aflibercept (Treatment Group B)
31
Loss ≥ 5 ETDRS Letters at Week 20
Group
Value
95% CI
KSI-301 (Treatment Group A)
35
Aflibercept (Treatment Group B)
27
Loss ≥ 5 ETDRS Letters at Week 24
Group
Value
95% CI
KSI-301 (Treatment Group A)
34
Aflibercept (Treatment Group B)
31
Loss ≥ 5 ETDRS Letters at Week 28
Group
Value
95% CI
KSI-301 (Treatment Group A)
38
Aflibercept (Treatment Group B)
31
Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters)Secondary· Day 1 to Week 48
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Snellen Equivalent of 20/40 or Better at Baseline
Group
Value
95% CI
KSI-301 (Treatment Group A)
122
Aflibercept (Treatment Group B)
129
Snellen Equivalent of 20/40 or Better at Week 2
Group
Value
95% CI
KSI-301 (Treatment Group A)
148
Aflibercept (Treatment Group B)
152
Snellen Equivalent of 20/40 or Better at Week 4
Group
Value
95% CI
KSI-301 (Treatment Group A)
156
Aflibercept (Treatment Group B)
165
Snellen Equivalent of 20/40 or Better at Week 8
Group
Value
95% CI
KSI-301 (Treatment Group A)
156
Aflibercept (Treatment Group B)
165
Snellen Equivalent of 20/40 or Better at Week 12
Group
Value
95% CI
KSI-301 (Treatment Group A)
148
Aflibercept (Treatment Group B)
171
Snellen Equivalent of 20/40 or Better at Week 16
Group
Value
95% CI
KSI-301 (Treatment Group A)
149
Aflibercept (Treatment Group B)
172
Snellen Equivalent of 20/40 or Better at Week 20
Group
Value
95% CI
KSI-301 (Treatment Group A)
151
Aflibercept (Treatment Group B)
179
Snellen Equivalent of 20/40 or Better at Week 24
Group
Value
95% CI
KSI-301 (Treatment Group A)
158
Aflibercept (Treatment Group B)
183
Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters)Secondary· Day 1 to Week 48
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Snellen Equivalent of 20/200 or Worse at Baseline
Group
Value
95% CI
KSI-301 (Treatment Group A)
17
Aflibercept (Treatment Group B)
15
Snellen Equivalent of 20/200 or Worse at Week 2
Group
Value
95% CI
KSI-301 (Treatment Group A)
11
Aflibercept (Treatment Group B)
12
Snellen Equivalent of 20/200 or Worse at Week 4
Group
Value
95% CI
KSI-301 (Treatment Group A)
10
Aflibercept (Treatment Group B)
14
Snellen Equivalent of 20/200 or Worse at Week 8
Group
Value
95% CI
KSI-301 (Treatment Group A)
11
Aflibercept (Treatment Group B)
13
Snellen Equivalent of 20/200 or Worse at Week 12
Group
Value
95% CI
KSI-301 (Treatment Group A)
11
Aflibercept (Treatment Group B)
12
Snellen Equivalent of 20/200 or Worse at Week 16
Group
Value
95% CI
KSI-301 (Treatment Group A)
11
Aflibercept (Treatment Group B)
10
Snellen Equivalent of 20/200 or Worse at Week 20
Group
Value
95% CI
KSI-301 (Treatment Group A)
13
Aflibercept (Treatment Group B)
13
Snellen Equivalent of 20/200 or Worse at Week 24
Group
Value
95% CI
KSI-301 (Treatment Group A)
11
Aflibercept (Treatment Group B)
13
Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over TimeSecondary· Day 1 to Week 48
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) as assessed by a central reading center.
Week 2
Group
Value
95% CI
KSI-301 (Treatment Group A)
-72.1
± 83.74
Aflibercept (Treatment Group B)
-99.9
± 93.75
Week 4
Group
Value
95% CI
KSI-301 (Treatment Group A)
-74.9
± 98.33
Aflibercept (Treatment Group B)
-109.4
± 100.87
Week 8
Group
Value
95% CI
KSI-301 (Treatment Group A)
-89.1
± 121.13
Aflibercept (Treatment Group B)
-122.2
± 109.58
Week 12
Group
Value
95% CI
KSI-301 (Treatment Group A)
-97.1
± 118.62
Aflibercept (Treatment Group B)
-126.3
± 111.55
Week 16
Group
Value
95% CI
KSI-301 (Treatment Group A)
-107.2
± 110.02
Aflibercept (Treatment Group B)
-99.2
± 110.47
Week 20
Group
Value
95% CI
KSI-301 (Treatment Group A)
-111
± 112.97
Aflibercept (Treatment Group B)
-125.5
± 117.39
Week 24
Group
Value
95% CI
KSI-301 (Treatment Group A)
-109.9
± 112.82
Aflibercept (Treatment Group B)
-101.8
± 113.21
Week 28
Group
Value
95% CI
KSI-301 (Treatment Group A)
-114.6
± 111.47
Aflibercept (Treatment Group B)
-124.1
± 111.51
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AEs) reported through Week 52 or Early Termination (ET).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
KSI-301 (Treatment Group A)
Serious: 39/276 (14%)
Deaths: 4/276
Aflibercept (Treatment Group B)
Serious: 39/281 (14%)
Deaths: 3/281
Serious adverse events (95 terms)
Reaction
System
KSI-301 (Treatment Group A)
Aflibercept (Treatment Gro…
Anaemia
Blood and lymphatic system disorders
—
—
Pneumonia
Infections and infestations
—
—
Atrial fibrillation
Cardiac disorders
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Retinal detachment - Study eye
Eye disorders
—
—
COVID-19 pneumonia
Infections and infestations
—
—
Clostridium difficile colitis
Infections and infestations
—
—
Sepsis
Infections and infestations
—
—
Acute myocardial infarction
Cardiac disorders
—
—
Coronary artery disease
Cardiac disorders
—
—
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
—
—
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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)
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05066230 — A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)
· Phase 3
· terminated
NCT04603937 — A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabeti
· Phase 3
· terminated
NCT04611152 — A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabeti
· Phase 3
· terminated
NCT04592419 — A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Ede
· Phase 3
· completed
NCT04049266 — A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept i
· Phase 2, PHASE3
· terminated
Other recruiting trials for Wet Age-related Macular Degeneration
Currently open trials in the same condition.
NCT06859515 — A Long-term Follow up Study of EXG102-031 in Participants With wAMD
· recruiting
NCT04645212 — Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]
· active not recruiting
NCT06270836 — A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Dia
· Phase 3
· active not recruiting
NCT05066230 — A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)
· Phase 3
· terminated
NCT04611152 — A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabeti
· Phase 3
· terminated
NCT04603937 — A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabeti
· Phase 3
· terminated
NCT04592419 — A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Ede
· Phase 3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kodiak Sciences Inc
Last refreshed: 3 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04964089.