Trial Outcomes & Findings for Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE) (NCT NCT06011798)
NCT ID: NCT06011798
Last Updated: 2025-08-05
Results Overview
Mean change from baseline to the average of Week 20 and Week 24 in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Week 24
Results posted on
2025-08-05
Participant Flow
Participant milestones
| Measure |
Anti-VEGF Control Arm
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 2 mg aflibercept (50 μl of 40 μg/μl solution) IVT on Day 1, Weeks 8, and 16. A sham procedure will also be administered on Day 1.
Aflibercept: Anti-VEGF control
|
Foselutoclax Arm
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 10 μg foselutoclax (50 μl of 0.2 μg/μl solution) IVT on Day 1 and Weeks 8 and 16. 2 mg aflibercept (50 μl of 40 μg/μl solution) will also be administered on Day 1.
Aflibercept: Anti-VEGF control
foselutoclax: Experimental drug
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)
Baseline characteristics by cohort
| Measure |
Anti-VEGF Control Arm
n=26 Participants
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 2 mg aflibercept (50 μl of 40 μg/μl solution) IVT on Day 1, Weeks 8, and 16. A sham procedure will also be administered on Day 1.
Aflibercept: Anti-VEGF control
|
Foselutoclax Arm
n=26 Participants
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 10 μg foselutoclax (50 μl of 0.2 μg/μl solution) IVT on Day 1 and Weeks 8 and 16. 2 mg aflibercept (50 μl of 40 μg/μl solution) will also be administered on Day 1.
Aflibercept: Anti-VEGF control
foselutoclax: Experimental drug
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 8.73 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 7.57 • n=7 Participants
|
66.1 years
STANDARD_DEVIATION 8.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Mean change from baseline to the average of Week 20 and Week 24 in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter
Outcome measures
| Measure |
Anti-VEGF Control Arm
n=26 Participants
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 2 mg aflibercept (50 μl of 40 μg/μl solution) IVT on Day 1, Weeks 8, and 16. A sham procedure will also be administered on Day 1.
Aflibercept: Anti-VEGF control
|
Foselutoclax Arm
n=26 Participants
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 10 μg foselutoclax (50 μl of 0.2 μg/μl solution) IVT on Day 1 and Weeks 8 and 16. 2 mg aflibercept (50 μl of 40 μg/μl solution) will also be administered on Day 1.
Aflibercept: Anti-VEGF control
foselutoclax: Experimental drug
|
|---|---|---|
|
Mean Change From Baseline to Average of Week 20 and Week 24 in BCVA by ETDRS Letter
|
5.1 change in ETDRS letters
Standard Error 1.35
|
3.7 change in ETDRS letters
Standard Error 1.36
|
SECONDARY outcome
Timeframe: 36 weeksChanges in BCVA (ETDRS letters) from baseline to Week 36
Outcome measures
| Measure |
Anti-VEGF Control Arm
n=23 Participants
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 2 mg aflibercept (50 μl of 40 μg/μl solution) IVT on Day 1, Weeks 8, and 16. A sham procedure will also be administered on Day 1.
Aflibercept: Anti-VEGF control
|
Foselutoclax Arm
n=24 Participants
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 10 μg foselutoclax (50 μl of 0.2 μg/μl solution) IVT on Day 1 and Weeks 8 and 16. 2 mg aflibercept (50 μl of 40 μg/μl solution) will also be administered on Day 1.
Aflibercept: Anti-VEGF control
foselutoclax: Experimental drug
|
|---|---|---|
|
Assess Other Efficacy Outcome - Changes in BCVA From Baseline to Week 36
|
4.7 change in ETDRS letters
Standard Error 1.63
|
4.6 change in ETDRS letters
Standard Error 1.59
|
SECONDARY outcome
Timeframe: 36 weeksChange in Central Subfield Thickness (CST) as measured in microns from baseline to Week 36
Outcome measures
| Measure |
Anti-VEGF Control Arm
n=23 Participants
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 2 mg aflibercept (50 μl of 40 μg/μl solution) IVT on Day 1, Weeks 8, and 16. A sham procedure will also be administered on Day 1.
Aflibercept: Anti-VEGF control
|
Foselutoclax Arm
n=24 Participants
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 10 μg foselutoclax (50 μl of 0.2 μg/μl solution) IVT on Day 1 and Weeks 8 and 16. 2 mg aflibercept (50 μl of 40 μg/μl solution) will also be administered on Day 1.
Aflibercept: Anti-VEGF control
foselutoclax: Experimental drug
|
|---|---|---|
|
Assess Other Efficacy Outcome - Changes in CST From Baseline to Week 36
|
9.2 microns
Standard Error 23.69
|
-1.9 microns
Standard Error 23.33
|
SECONDARY outcome
Timeframe: 36 weeksAt any visit, including Unscheduled visits, patients who exhibited increase in disease activity, were allowed to be rescued with aflibercept. Increase in disease activity was defined as ANY of the following: * Worsening CST by ≥75 µm from baseline per SD-OCT * A ≥10 letter decrease in BCVA compared to baseline * New clinically significant blood or heme present compared to previous visit * PI discretion (rationale to be documented in the EDC)
Outcome measures
| Measure |
Anti-VEGF Control Arm
n=26 Participants
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 2 mg aflibercept (50 μl of 40 μg/μl solution) IVT on Day 1, Weeks 8, and 16. A sham procedure will also be administered on Day 1.
Aflibercept: Anti-VEGF control
|
Foselutoclax Arm
n=26 Participants
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 10 μg foselutoclax (50 μl of 0.2 μg/μl solution) IVT on Day 1 and Weeks 8 and 16. 2 mg aflibercept (50 μl of 40 μg/μl solution) will also be administered on Day 1.
Aflibercept: Anti-VEGF control
foselutoclax: Experimental drug
|
|---|---|---|
|
Assess Other Efficacy Outcome - Rescue Metrics
No Rescues
|
61.5 percentage of participants
|
34 percentage of participants
|
|
Assess Other Efficacy Outcome - Rescue Metrics
1 Rescue
|
23.1 percentage of participants
|
34.6 percentage of participants
|
|
Assess Other Efficacy Outcome - Rescue Metrics
> = 2 Rescues
|
15.4 percentage of participants
|
30.8 percentage of participants
|
SECONDARY outcome
Timeframe: 36 weeksNumber of participants with treatment-emergent adverse event (TEAE)
Outcome measures
| Measure |
Anti-VEGF Control Arm
n=26 Participants
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 2 mg aflibercept (50 μl of 40 μg/μl solution) IVT on Day 1, Weeks 8, and 16. A sham procedure will also be administered on Day 1.
Aflibercept: Anti-VEGF control
|
Foselutoclax Arm
n=26 Participants
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 10 μg foselutoclax (50 μl of 0.2 μg/μl solution) IVT on Day 1 and Weeks 8 and 16. 2 mg aflibercept (50 μl of 40 μg/μl solution) will also be administered on Day 1.
Aflibercept: Anti-VEGF control
foselutoclax: Experimental drug
|
|---|---|---|
|
Assess Safety Outcome - Safety and Tolerability
Participants with at least one Ocular TEAE in Study Eye
|
12 Participants
|
19 Participants
|
|
Assess Safety Outcome - Safety and Tolerability
Participants with at least one related Ocular TEAE in Study Eye
|
8 Participants
|
8 Participants
|
|
Assess Safety Outcome - Safety and Tolerability
Participants with at least one Ocular TESAE in Study Eye
|
1 Participants
|
0 Participants
|
|
Assess Safety Outcome - Safety and Tolerability
Participants with at least one Ocular TEAE in Non-Study Eye
|
2 Participants
|
6 Participants
|
|
Assess Safety Outcome - Safety and Tolerability
Participants with at least one related Ocular TEAE in Non-Study Eye
|
1 Participants
|
0 Participants
|
|
Assess Safety Outcome - Safety and Tolerability
Participants with at least one non-ocular TESAE
|
5 Participants
|
5 Participants
|
|
Assess Safety Outcome - Safety and Tolerability
Participants with at least one TEAE
|
15 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Subjects with at least one ocular TEAE in study eye
Ocular Safety is evaluated by incidence of ocular Treatment Emergent Adverse Events (TEAEs).
Outcome measures
| Measure |
Anti-VEGF Control Arm
n=26 Participants
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 2 mg aflibercept (50 μl of 40 μg/μl solution) IVT on Day 1, Weeks 8, and 16. A sham procedure will also be administered on Day 1.
Aflibercept: Anti-VEGF control
|
Foselutoclax Arm
n=26 Participants
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 10 μg foselutoclax (50 μl of 0.2 μg/μl solution) IVT on Day 1 and Weeks 8 and 16. 2 mg aflibercept (50 μl of 40 μg/μl solution) will also be administered on Day 1.
Aflibercept: Anti-VEGF control
foselutoclax: Experimental drug
|
|---|---|---|
|
Ocular Safety and Tolerability
subjects with at least one ocular TEAE in study eye
|
12 Participants
|
19 Participants
|
|
Ocular Safety and Tolerability
diabetic retinal oedema
|
8 Participants
|
15 Participants
|
|
Ocular Safety and Tolerability
conjunctival haemorrhage
|
8 Participants
|
15 Participants
|
|
Ocular Safety and Tolerability
conjunctival hyperaemia
|
22 Participants
|
2 Participants
|
|
Ocular Safety and Tolerability
punctate keratitis
|
2 Participants
|
1 Participants
|
|
Ocular Safety and Tolerability
cataract aggravated
|
10 Participants
|
1 Participants
|
|
Ocular Safety and Tolerability
posterior capsule opacification
|
0 Participants
|
2 Participants
|
|
Ocular Safety and Tolerability
conjunctivochalasis
|
0 Participants
|
1 Participants
|
|
Ocular Safety and Tolerability
diabetic retinopathy
|
1 Participants
|
0 Participants
|
|
Ocular Safety and Tolerability
dry eye
|
0 Participants
|
1 Participants
|
|
Ocular Safety and Tolerability
retinal detachment
|
1 Participants
|
0 Participants
|
|
Ocular Safety and Tolerability
subretinal fluid
|
0 Participants
|
1 Participants
|
|
Ocular Safety and Tolerability
visual acuity reduced
|
0 Participants
|
1 Participants
|
|
Ocular Safety and Tolerability
vitreous detachment
|
0 Participants
|
1 Participants
|
|
Ocular Safety and Tolerability
vitreous floaters
|
0 Participants
|
1 Participants
|
|
Ocular Safety and Tolerability
hordeolum
|
0 Participants
|
1 Participants
|
|
Ocular Safety and Tolerability
corneal abrasion
|
1 Participants
|
0 Participants
|
Adverse Events
Anti-VEGF Control Arm - Run-In Period
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Foselutoclax Arm - Run-In Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anti-VEGF Control Arm
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Foselutoclax Arm
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anti-VEGF Control Arm - Run-In Period
n=26 participants at risk
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals.
|
Foselutoclax Arm - Run-In Period
n=26 participants at risk
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals.
|
Anti-VEGF Control Arm
n=26 participants at risk
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 2 mg aflibercept (50 μl of 40 μg/μl solution) IVT on Day 1, Weeks 8, and 16. A sham procedure will also be administered on Day 1.
Aflibercept: Anti-VEGF control
|
Foselutoclax Arm
n=26 participants at risk
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 10 μg foselutoclax (50 μl of 0.2 μg/μl solution) IVT on Day 1 and Weeks 8 and 16. 2 mg aflibercept (50 μl of 40 μg/μl solution) will also be administered on Day 1.
Aflibercept: Anti-VEGF control
foselutoclax: Experimental drug
|
|---|---|---|---|---|
|
Eye disorders
Retinal detachment
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
3.8%
1/26 • Number of events 1 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
3.8%
1/26 • Number of events 1 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
3.8%
1/26 • Number of events 1 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Infections and infestations
Localized Infection
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
3.8%
1/26 • Number of events 1 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
3.8%
1/26 • Number of events 1 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
3.8%
1/26 • Number of events 1 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
3.8%
1/26 • Number of events 1 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
3.8%
1/26 • Number of events 1 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Metabolism and nutrition disorders
Shock hypoglycaemic
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
3.8%
1/26 • Number of events 1 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
3.8%
1/26 • Number of events 1 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
3.8%
1/26 • Number of events 1 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
3.8%
1/26 • Number of events 1 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Vascular disorders
Hypotension
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
3.8%
1/26 • Number of events 1 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
Other adverse events
| Measure |
Anti-VEGF Control Arm - Run-In Period
n=26 participants at risk
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals.
|
Foselutoclax Arm - Run-In Period
n=26 participants at risk
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals.
|
Anti-VEGF Control Arm
n=26 participants at risk
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 2 mg aflibercept (50 μl of 40 μg/μl solution) IVT on Day 1, Weeks 8, and 16. A sham procedure will also be administered on Day 1.
Aflibercept: Anti-VEGF control
|
Foselutoclax Arm
n=26 participants at risk
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 10 μg foselutoclax (50 μl of 0.2 μg/μl solution) IVT on Day 1 and Weeks 8 and 16. 2 mg aflibercept (50 μl of 40 μg/μl solution) will also be administered on Day 1.
Aflibercept: Anti-VEGF control
foselutoclax: Experimental drug
|
|---|---|---|---|---|
|
Eye disorders
Diabetic retinal oedema (Study eye)
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
30.8%
8/26 • Number of events 8 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
57.7%
15/26 • Number of events 15 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Eye disorders
Conjunctival haemorrhage (Study eye)
|
7.7%
2/26 • Number of events 2 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
15.4%
4/26 • Number of events 4 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
19.2%
5/26 • Number of events 5 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Eye disorders
Conjunctival hyperaemia (Study eye)
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
7.7%
2/26 • Number of events 2 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
7.7%
2/26 • Number of events 2 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Eye disorders
Punctate keratitis (Study eye)
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
7.7%
2/26 • Number of events 2 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
3.8%
1/26 • Number of events 1 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Eye disorders
Diabetic retinal oedema (non-study eye)
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
7.7%
2/26 • Number of events 2 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Eye disorders
Posterior capsule opacification (Study eye)
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
7.7%
2/26 • Number of events 2 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
7.7%
2/26 • Number of events 2 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
3.8%
1/26 • Number of events 1 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
7.7%
2/26 • Number of events 2 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
7.7%
2/26 • Number of events 2 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
0.00%
0/26 • Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place