Trial Outcomes & Findings for Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION) (NCT NCT05275205)
NCT ID: NCT05275205
Last Updated: 2024-08-07
Results Overview
Ocular and systemic safety and tolerability of a repeat IVT injection of UBX1325 compared to active-control (aflibercept) evaluated by treatment emergent adverse events (TEAEs) through Week 24
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Through 24 weeks
Results posted on
2024-08-07
Participant Flow
Participant milestones
| Measure |
UBX1325
UBX1325 injection 50 μL: Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28
|
Aflibercept (EYLEA ®)
EYLEA® (aflibercept) Injection 2 mg (0.05mL): Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
UBX1325
UBX1325 injection 50 μL: Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28
|
Aflibercept (EYLEA ®)
EYLEA® (aflibercept) Injection 2 mg (0.05mL): Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Patient unable to attend visits
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION)
Baseline characteristics by cohort
| Measure |
Aflibercept (EYLEA ®)
n=25 Participants
EYLEA® (aflibercept) Injection 2 mg (0.05mL): Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.
|
Total
n=50 Participants
Total of all reporting groups
|
UBX1325
n=25 Participants
UBX1325 injection 50 μL: Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28
|
|---|---|---|---|
|
Age, Continuous
|
78.4 years
STANDARD_DEVIATION 7.47 • n=7 Participants
|
78.9 years
STANDARD_DEVIATION 8.11 • n=5 Participants
|
79.3 years
STANDARD_DEVIATION 8.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Study eye
Left eye (OS)
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
16 Participants
n=5 Participants
|
|
Study eye
Right eye (OD)
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
9 Participants
n=5 Participants
|
|
Eye colour
Blue
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
11 Participants
n=5 Participants
|
|
Eye colour
Brown
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
|
Eye colour
Green
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
|
Eye colour
Hazel
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 24 weeksPopulation: The Safety Analysis Set will include all patients who received study treatment.
Ocular and systemic safety and tolerability of a repeat IVT injection of UBX1325 compared to active-control (aflibercept) evaluated by treatment emergent adverse events (TEAEs) through Week 24
Outcome measures
| Measure |
UBX-1325
n=25 Participants
UBX1325 injection 50 μL: Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28.
|
EYLEA® (Aflibercept)
n=25 Participants
EYLEA® (aflibercept) Injection 2 mg (0.05mL): Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.
|
|---|---|---|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Subjects with At Least One TEAE
|
19 Participants
|
18 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Cardiac disorders-Atrial fibrillation
|
2 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Cardiac disorders-Angina unstable
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Cardiac disorders-Cardiac failure congestive
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Cardiac disorders-Coronary artery disease
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Endocrine disorders-Hypothyroidism
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Neovascular age-related macular degeneration
|
5 Participants
|
3 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Conjunctival haemorrhage
|
1 Participants
|
5 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Retinal haemorrhage
|
4 Participants
|
2 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Macular oedema
|
5 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Dry eye
|
1 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Punctate keratitis
|
1 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Blepharitis
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Macular degeneration
|
0 Participants
|
2 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Macular thickening
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Blindness unilateral
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Cataract
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Cataract cortical
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Diabetic retinopathy
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Lacrimation increased
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Macular detachment
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Optic nerve sheath haemorrhage
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Pinguecula
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Retinal exudates
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Visual acuity reduced
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Eye disorders-Vitreous haemorrhage
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Gastrointestinal disorders-Gastrooesophageal reflux disease
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Gastrointestinal disorders-Hiatus hernia
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Gastrointestinal disorders-Large intestine polyp
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Gastrointestinal disorders-Nausea
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Gastrointestinal disorders-Retroperitoneal haemorrhage
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Gastrointestinal disorders-Toothache
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
General disorders and administration site conditions-Asthenia
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
General disorders and administration site conditions-Influenza like illness
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
General disorders and administration site conditions-Multiple organ dysfunction syndrome
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
General disorders and administration site conditions-Oedema peripheral
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Infections and infestations-COVID-19
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Infections and infestations-Fungal infection
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Infections and infestations-Urinary tract infection
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Injury, poisoning and procedural complications-Corneal abrasion
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Injury, poisoning and procedural complications-Facial bones fracture
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Injury, poisoning and procedural complications-Fall
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Injury, poisoning and procedural complications-Radius fracture
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Metabolism and nutrition disorders-Dehydration
|
1 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Metabolism and nutrition disorders-Hypoglycaemia
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Metabolism and nutrition disorders-Hypokalaemia
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Musculoskeletal and connective tissue disorders-Arthritis
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Meningioma
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Rectal cancer stage III
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Squamous cell carcinoma
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Nervous system disorders-Carotid arteriosclerosis
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Renal and urinary disorders-Acute kidney injury
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Renal and urinary disorders-Renal haematoma
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Respiratory, thoracic and mediastinal disorders-Chronic obstructive pulmonary -disease
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Respiratory, thoracic and mediastinal disorders-Rhinitis allergic
|
0 Participants
|
1 Participants
|
|
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Surgical and medical procedures-Finger amputation
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through 48 weeksPopulation: MMRM Model for BCVA Change from Baseline (Hypothetical Strategy) Full Analysis Set. The hypothetical strategy included all subjects but excluded measurements post anti-VEGF rescue from the analysis. The Full Analysis Set included all randomized patients who received study treatment, had a baseline and at least one post baseline BCVA assessment.
BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart starting at 4 meters.
Outcome measures
| Measure |
UBX-1325
n=25 Participants
UBX1325 injection 50 μL: Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28.
|
EYLEA® (Aflibercept)
n=25 Participants
EYLEA® (aflibercept) Injection 2 mg (0.05mL): Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.
|
|---|---|---|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Baseline
|
58 ETDRS Letters
Standard Error 13.47
|
62.4 ETDRS Letters
Standard Error 9.46
|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Week 2
|
-0.2 ETDRS Letters
Standard Error 1.99
|
3.1 ETDRS Letters
Standard Error 0.85
|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Week 4
|
1.7 ETDRS Letters
Standard Error 1.45
|
3.0 ETDRS Letters
Standard Error 1.08
|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Week 8
|
0.6 ETDRS Letters
Standard Error 1.36
|
3.2 ETDRS Letters
Standard Error 1.12
|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Week 12
|
1.1 ETDRS Letters
Standard Error 1.37
|
2.7 ETDRS Letters
Standard Error 1.5
|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Week 16
|
-1.9 ETDRS Letters
Standard Error 2.87
|
2.2 ETDRS Letters
Standard Error 1.49
|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Week 20
|
0.7 ETDRS Letters
Standard Error 1.96
|
2.5 ETDRS Letters
Standard Error 1.69
|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Week 24
|
0.1 ETDRS Letters
Standard Error 2.25
|
2.2 ETDRS Letters
Standard Error 1.42
|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Week 28
|
-0.5 ETDRS Letters
Standard Error 1.86
|
3.2 ETDRS Letters
Standard Error 1.56
|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Week 32
|
-2.4 ETDRS Letters
Standard Error 1.99
|
2.1 ETDRS Letters
Standard Error 1.53
|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Week 36
|
-4.1 ETDRS Letters
Standard Error 2.91
|
2.5 ETDRS Letters
Standard Error 1.43
|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Week 40
|
-4.9 ETDRS Letters
Standard Error 2.38
|
3.4 ETDRS Letters
Standard Error 1.44
|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Week 44
|
-0.5 ETDRS Letters
Standard Error 2.71
|
1.8 ETDRS Letters
Standard Error 1.63
|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Week 48
|
-1.5 ETDRS Letters
Standard Error 3.24
|
1.7 ETDRS Letters
Standard Error 1.73
|
SECONDARY outcome
Timeframe: Through 48 weeksPopulation: MMRM Model for CST Change from Baseline (Hypothetical Strategy) Full Analysis Set. The hypothetical strategy included all subjects but excluded measurements post anti-VEGF rescue from the analysis. The Full Analysis Set included all randomized patients who received study treatment, had a baseline and at least one post baseline BCVA assessment.
Central Subfield Thickness (CST) measured in microns using spectral domain optical coherence tomography (SD-OCT).
Outcome measures
| Measure |
UBX-1325
n=25 Participants
UBX1325 injection 50 μL: Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28.
|
EYLEA® (Aflibercept)
n=25 Participants
EYLEA® (aflibercept) Injection 2 mg (0.05mL): Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.
|
|---|---|---|
|
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Baseline
|
374.1 Microns
Standard Error 105.72
|
367.5 Microns
Standard Error 151.75
|
|
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Week 2
|
29.9 Microns
Standard Error 10.77
|
-35.0 Microns
Standard Error 6.50
|
|
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Week 4
|
56.6 Microns
Standard Error 25.51
|
-14.9 Microns
Standard Error 5.89
|
|
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Week 8
|
92.0 Microns
Standard Error 20.52
|
15.2 Microns
Standard Error 8.55
|
|
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Week 12
|
119.6 Microns
Standard Error 25.07
|
-18.0 Microns
Standard Error 8.72
|
|
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Week 16
|
85.6 Microns
Standard Error 16.74
|
22.2 Microns
Standard Error 10.14
|
|
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Week 20
|
64.9 Microns
Standard Error 14.74
|
-16.4 Microns
Standard Error 7.82
|
|
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Week 24
|
71.2 Microns
Standard Error 13.65
|
31.7 Microns
Standard Error 9.57
|
|
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Week 28
|
94.3 Microns
Standard Error 20.72
|
-6.4 Microns
Standard Error 8.33
|
|
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Week 32
|
102.3 Microns
Standard Error 23.61
|
26.4 Microns
Standard Error 9.72
|
|
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Week 36
|
67.8 Microns
Standard Error 16.19
|
-29.4 Microns
Standard Error 17.29
|
|
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Week 40
|
66.9 Microns
Standard Error 20.43
|
23.3 Microns
Standard Error 10.77
|
|
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Week 44
|
66.1 Microns
Standard Error 15.23
|
-23.3 Microns
Standard Error 7.77
|
|
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Week 48
|
77.2 Microns
Standard Error 16.38
|
28.2 Microns
Standard Error 10.25
|
SECONDARY outcome
Timeframe: Through 48 weeksPopulation: The Safety Analysis Set will include all patients who received study treatment.
Safety is evaluated by incidence of Treatment Emergent Adverse Events (TEAEs).
Outcome measures
| Measure |
UBX-1325
n=25 Participants
UBX1325 injection 50 μL: Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28.
|
EYLEA® (Aflibercept)
n=25 Participants
EYLEA® (aflibercept) Injection 2 mg (0.05mL): Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.
|
|---|---|---|
|
Adverse Events (Safety)
Renal and urinary disorders-Acute kidney injury
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Subjects with At Least One TEAE
|
20 Participants
|
20 Participants
|
|
Adverse Events (Safety)
Blood and lymphatic system disorders-Anaemia
|
0 Participants
|
2 Participants
|
|
Adverse Events (Safety)
Cardiac disorders-Atrial fibrillation
|
2 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Cardiac disorders-Angina unstable
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Cardiac disorders-Arrhythmia supraventricular
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Cardiac disorders-Cardiac failure congestive
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Cardiac disorders-Coronary artery disease
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Cardiac disorders-Ventricular extrasystoles
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Congenital, familial and genetic disorders-Hydrocele
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Ear and labyrinth disorders-Vertigo
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Endocrine disorders-Hypothyroidism
|
2 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Eye disorders-Neovascular age-related macular degeneration
|
7 Participants
|
7 Participants
|
|
Adverse Events (Safety)
Eye disorders-Conjunctival haemorrhage
|
1 Participants
|
8 Participants
|
|
Adverse Events (Safety)
Eye disorders-Retinal haemorrhage
|
6 Participants
|
3 Participants
|
|
Adverse Events (Safety)
Eye disorders-Macular oedema
|
5 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Eye disorders-Macular thickening
|
2 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Eye disorders-Dry eye
|
1 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Eye disorders-Punctate keratitis
|
1 Participants
|
2 Participants
|
|
Adverse Events (Safety)
Eye disorders-Subretinal fluid
|
3 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Eye disorders-Visual acuity reduced
|
3 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Eye disorders-Blepharitis
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Eye disorders-Cataract
|
1 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Eye disorders-Lacrimation increased
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Eye disorders-Macular degeneration
|
0 Participants
|
2 Participants
|
|
Adverse Events (Safety)
Eye disorders-Optic nerve sheath haemorrhage
|
0 Participants
|
2 Participants
|
|
Adverse Events (Safety)
Eye disorders-Retinal exudates
|
1 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Eye disorders-Retinal oedema
|
2 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Eye disorders-Vitreous haemorrhage
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Eye disorders-Blindness unilateral
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Eye disorders-Cataract cortical
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Eye disorders-Diabetic retinopathy
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Eye disorders-Macular detachment
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Eye disorders-Pinguecula
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Eye disorders-Posterior capsule opacification
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Uveitis
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Visual impairment
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Gastrointestinal disorders-Nausea
|
2 Participants
|
2 Participants
|
|
Adverse Events (Safety)
Gastrointestinal disorders-Constipation
|
0 Participants
|
2 Participants
|
|
Adverse Events (Safety)
Gastrointestinal disorders-Gastrooesophageal reflux disease
|
0 Participants
|
2 Participants
|
|
Adverse Events (Safety)
Gastrointestinal disorders-Dyspepsia
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Gastrointestinal disorders-Gingival recession
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Gastrointestinal disorders-Hiatus hernia
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Gastrointestinal disorders-Large intestine polyp
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Gastrointestinal disorders-Retroperitoneal haemorrhage
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Gastrointestinal disorders-Toothache
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Gastrointestinal disorders-Vomiting
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
General disorders and administration site conditions-Oedema peripheral
|
0 Participants
|
2 Participants
|
|
Adverse Events (Safety)
General disorders and administration site conditions-Asthenia
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
General disorders and administration site conditions-Influenza like illness
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
General disorders and administration site conditions-Multiple organ dysfunction syndrome
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
General disorders and administration site conditions-Pain
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Infections and infestations-Urinary tract infection
|
1 Participants
|
2 Participants
|
|
Adverse Events (Safety)
Infections and infestations-COVID-19
|
1 Participants
|
2 Participants
|
|
Adverse Events (Safety)
Infections and infestations-Nasopharyngitis
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Infections and infestations-Bacteraemia
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Infections and infestations-Fungal infection
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Infections and infestations-Gastrointestinal bacterial infection
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Infections and infestations-Paronychia
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Infections and infestations-Pneumonia
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Infections and infestations-Urosepsis
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Infections and infestations-Viral rhinitis
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Injury, poisoning and procedural complications-Fall
|
1 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Injury, poisoning and procedural complications-Skin laceration
|
1 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Injury, poisoning and procedural complications-Corneal abrasion
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Injury, poisoning and procedural complications-Crush injury
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Injury, poisoning and procedural complications-Facial bones fracture
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Injury, poisoning and procedural complications-Femur fracture
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Injury, poisoning and procedural complications-Fibula fracture
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Injury, poisoning and procedural complications-Radius fracture
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Injury, poisoning and procedural complications-Rib fracture
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Injury, poisoning and procedural complications-Scapula fracture
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Injury, poisoning and procedural complications-Thoracic vertebral fracture
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Injury, poisoning and procedural complications-Wrist fracture
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Investigations-Heart rate irregular
|
1 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Investigations-Electrocardiogram QRS complex abnormal
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Investigations-QRS axis abnormal
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Metabolism and nutrition disorders-Dehydration
|
1 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Metabolism and nutrition disorders-Hypokalaemia
|
0 Participants
|
2 Participants
|
|
Adverse Events (Safety)
Metabolism and nutrition disorders-Hyperlipidaemia
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Metabolism and nutrition disorders-Hypoglycaemia
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Metabolism and nutrition disorders-Hypomagnesaemia
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Metabolism and nutrition disorders-Hypovolaemia
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Musculoskeletal and connective tissue disorders-Arthritis
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Musculoskeletal and connective tissue disorders-Rhabdomyolysis
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Meningioma
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Rectal cancer stage III
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Squamous cell carcinoma
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Nervous system disorders-Carotid arteriosclerosis
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Product issues-Device dislocation
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Psychiatric disorders-Insomnia
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Renal and urinary disorders-Nephropathy
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Renal and urinary disorders-Renal haematoma
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Respiratory, thoracic and mediastinal disorders-Asthma
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Respiratory, thoracic and mediastinal disorders-Chronic obstructive pulmonary disease
|
1 Participants
|
0 Participants
|
|
Adverse Events (Safety)
Respiratory, thoracic and mediastinal disorders-Mediastinal haematoma
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Respiratory, thoracic and mediastinal disorders-Respiratory failure
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Respiratory, thoracic and mediastinal disorders-Rhinitis allergic
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Surgical and medical procedures-Finger amputation
|
0 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Vascular disorders-Hypotension
|
1 Participants
|
1 Participants
|
|
Adverse Events (Safety)
Vascular disorders-Hypertension
|
0 Participants
|
1 Participants
|
Adverse Events
UBX1325
Serious events: 2 serious events
Other events: 20 other events
Deaths: 1 deaths
Aflibercept (EYLEA ®)
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
UBX1325
n=25 participants at risk
UBX1325 injection 50 μL: Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28
|
Aflibercept (EYLEA ®)
n=25 participants at risk
EYLEA® (aflibercept) Injection 2 mg (0.05mL): Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.
|
|---|---|---|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
General disorders
Multiple organ dysfunction syndrome
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Infections and infestations
Bacteraemia
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Infections and infestations
Urosepsis
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Injury, poisoning and procedural complications
Crush injury
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage III
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Renal and urinary disorders
Acute kidney injury
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Renal and urinary disorders
Renal haematoma
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
Other adverse events
| Measure |
UBX1325
n=25 participants at risk
UBX1325 injection 50 μL: Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28
|
Aflibercept (EYLEA ®)
n=25 participants at risk
EYLEA® (aflibercept) Injection 2 mg (0.05mL): Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Cardiac disorders
Atrial fibrillation
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Endocrine disorders
Hypothyroidism
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Eye disorders
Neovascular age-related macular degeneration
|
28.0%
7/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
28.0%
7/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Eye disorders
Conjunctival haemorrhage
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
32.0%
8/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Eye disorders
Retinal haemorrhage
|
24.0%
6/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
12.0%
3/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Eye disorders
Macular oedema
|
20.0%
5/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Eye disorders
Macular thickening
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Eye disorders
Punctate keratitis
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Eye disorders
Subretinal fluid
|
12.0%
3/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Eye disorders
Visual acuity reduced
|
12.0%
3/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Eye disorders
Macular degeneration
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Eye disorders
Optic nerve sheath haemorrhage
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Eye disorders
Retinal oedema
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Gastrointestinal disorders
Nausea
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
General disorders
Oedema peripheral
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Infections and infestations
COVID-19
|
4.0%
1/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
8.0%
2/25 • Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place