Neovascular Age-related Macular Degeneration
Conditions
Keywords
Wet AMD
Brief summary
This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.
Detailed description
This is a Phase 2 study. During Screening, every patient will receive a run-in injection of aflibercept. On Day 1, patients will be randomized to either the UBX1325 arm or the aflibercept arm. Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28; and sham procedure on Weeks 8, 16, 24, 32, and 40. 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.
Interventions
DRUGUBX1325 injection 50 μL
Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28
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.
Sponsors
Unity Biotechnology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This study is double-masked, masking patients and investigators to treatment assignment. In addition to this, any Clinical Research Organization and Sponsor team members who are actively engaged with the site will be masked. The injector will be unmasked. Some additional roles at the site, Clinical Research Organization and Sponsor levels are unmasked.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥50 years. * Active CNV associated with age-related macular degeneration as evidenced on FA and SD-OCT with presence of intraretinal or subretinal fluid at Screening and Day 1 * BCVA in the study eye (most affected) of 70 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart) at Screening. * Patients who have the capacity to give informed consent and who are willing and able to comply with all study-related procedures and assessments.
Exclusion criteria
* Concurrent disease in the study eye or structural damage, other than wet AMD, that could compromise BCVA, prevent BCVA improvement, require medical or surgical intervention during the study period, confound interpretation of the results, or interfere with assessment of toxicity or CFP in the study eye. * Any ocular/intraocular/periocular infection or inflammation in either eye in the past 12 weeks prior to screening * Subretinal hemorrhage with bleeding area of 4 or greater disc area in the study eye * History of vitreous hemorrhage in the study eye within 2 months prior to Screening * Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation or prevent the patient from fully participating in all aspects of the study * Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Through 24 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Through 48 weeks | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart starting at 4 meters. |
| 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 | Through 48 weeks | Central Subfield Thickness (CST) measured in microns using spectral domain optical coherence tomography (SD-OCT). |
| Adverse Events (Safety) | Through 48 weeks | Safety is evaluated by incidence of Treatment Emergent Adverse Events (TEAEs). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| UBX1325 UBX1325 injection 50 μL: Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28 | 25 |
| 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. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Patient unable to attend visits | 1 | 0 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | UBX1325 | Aflibercept (EYLEA ®) | Total |
|---|---|---|---|
| Age, Continuous | 79.3 years STANDARD_DEVIATION 8.83 | 78.4 years STANDARD_DEVIATION 7.47 | 78.9 years STANDARD_DEVIATION 8.11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 22 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Eye colour Blue | 11 Participants | 13 Participants | 24 Participants |
| Eye colour Brown | 6 Participants | 9 Participants | 15 Participants |
| Eye colour Green | 3 Participants | 0 Participants | 3 Participants |
| Eye colour Hazel | 5 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Not reported | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 24 Participants | 23 Participants | 47 Participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
| Study eye Left eye (OS) | 16 Participants | 12 Participants | 28 Participants |
| Study eye Right eye (OD) | 9 Participants | 13 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 25 | 0 / 25 |
| other Total, other adverse events | 20 / 25 | 20 / 25 |
| serious Total, serious adverse events | 2 / 25 | 3 / 25 |
Outcome results
Primary
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
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
Time frame: Through 24 weeks
Population: The Safety Analysis Set will include all patients who received study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 18 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 | 3 Participants |
| EYLEA® (Aflibercept) | 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 | 5 Participants |
| EYLEA® (Aflibercept) | 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 | 2 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
| EYLEA® (Aflibercept) | 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 |
| EYLEA® (Aflibercept) | 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 |
| EYLEA® (Aflibercept) | 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 | 1 Participants |
| EYLEA® (Aflibercept) | 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 | 2 Participants |
| EYLEA® (Aflibercept) | 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 | 0 Participants |
Secondary
Adverse Events (Safety)
Safety is evaluated by incidence of Treatment Emergent Adverse Events (TEAEs).
Time frame: Through 48 weeks
Population: The Safety Analysis Set will include all patients who received study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UBX-1325 | Adverse Events (Safety) | Injury, poisoning and procedural complications-Radius fracture | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Injury, poisoning and procedural complications-Rib fracture | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Injury, poisoning and procedural complications-Scapula fracture | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Injury, poisoning and procedural complications-Thoracic vertebral fracture | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Injury, poisoning and procedural complications-Wrist fracture | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Investigations-Heart rate irregular | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Investigations-Electrocardiogram QRS complex abnormal | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Investigations-QRS axis abnormal | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Metabolism and nutrition disorders-Dehydration | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Metabolism and nutrition disorders-Hypokalaemia | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Metabolism and nutrition disorders-Hyperlipidaemia | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Subjects with At Least One TEAE | 20 Participants |
| UBX-1325 | Adverse Events (Safety) | Blood and lymphatic system disorders-Anaemia | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Cardiac disorders-Atrial fibrillation | 2 Participants |
| UBX-1325 | Adverse Events (Safety) | Cardiac disorders-Angina unstable | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Cardiac disorders-Arrhythmia supraventricular | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Cardiac disorders-Cardiac failure congestive | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Cardiac disorders-Coronary artery disease | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Cardiac disorders-Ventricular extrasystoles | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Congenital, familial and genetic disorders-Hydrocele | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Ear and labyrinth disorders-Vertigo | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Endocrine disorders-Hypothyroidism | 2 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Neovascular age-related macular degeneration | 7 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Conjunctival haemorrhage | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Retinal haemorrhage | 6 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Macular oedema | 5 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Macular thickening | 2 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Dry eye | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Punctate keratitis | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Subretinal fluid | 3 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Visual acuity reduced | 3 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Blepharitis | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Cataract | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Lacrimation increased | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Macular degeneration | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Optic nerve sheath haemorrhage | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Retinal exudates | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Retinal oedema | 2 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Vitreous haemorrhage | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Blindness unilateral | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Cataract cortical | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Diabetic retinopathy | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Macular detachment | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Pinguecula | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Eye disorders-Posterior capsule opacification | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Uveitis | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Visual impairment | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Gastrointestinal disorders-Nausea | 2 Participants |
| UBX-1325 | Adverse Events (Safety) | Gastrointestinal disorders-Constipation | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Gastrointestinal disorders-Gastrooesophageal reflux disease | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Gastrointestinal disorders-Dyspepsia | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Gastrointestinal disorders-Gingival recession | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Gastrointestinal disorders-Hiatus hernia | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Gastrointestinal disorders-Large intestine polyp | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Gastrointestinal disorders-Retroperitoneal haemorrhage | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Gastrointestinal disorders-Toothache | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Gastrointestinal disorders-Vomiting | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | General disorders and administration site conditions-Oedema peripheral | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | General disorders and administration site conditions-Asthenia | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | General disorders and administration site conditions-Influenza like illness | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | General disorders and administration site conditions-Multiple organ dysfunction syndrome | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | General disorders and administration site conditions-Pain | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Infections and infestations-Urinary tract infection | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Infections and infestations-COVID-19 | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Infections and infestations-Nasopharyngitis | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Infections and infestations-Bacteraemia | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Infections and infestations-Fungal infection | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Infections and infestations-Gastrointestinal bacterial infection | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Infections and infestations-Paronychia | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Infections and infestations-Pneumonia | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Infections and infestations-Urosepsis | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Infections and infestations-Viral rhinitis | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Injury, poisoning and procedural complications-Fall | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Injury, poisoning and procedural complications-Skin laceration | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Injury, poisoning and procedural complications-Corneal abrasion | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Injury, poisoning and procedural complications-Crush injury | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Injury, poisoning and procedural complications-Facial bones fracture | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Injury, poisoning and procedural complications-Femur fracture | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Injury, poisoning and procedural complications-Fibula fracture | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Metabolism and nutrition disorders-Hypoglycaemia | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Metabolism and nutrition disorders-Hypomagnesaemia | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Metabolism and nutrition disorders-Hypovolaemia | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Musculoskeletal and connective tissue disorders-Arthritis | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Musculoskeletal and connective tissue disorders-Rhabdomyolysis | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Meningioma | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Rectal cancer stage III | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Squamous cell carcinoma | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Nervous system disorders-Carotid arteriosclerosis | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Product issues-Device dislocation | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Psychiatric disorders-Insomnia | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Renal and urinary disorders-Acute kidney injury | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Renal and urinary disorders-Nephropathy | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Renal and urinary disorders-Renal haematoma | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Respiratory, thoracic and mediastinal disorders-Asthma | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Respiratory, thoracic and mediastinal disorders-Chronic obstructive pulmonary disease | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Respiratory, thoracic and mediastinal disorders-Mediastinal haematoma | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Respiratory, thoracic and mediastinal disorders-Respiratory failure | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Respiratory, thoracic and mediastinal disorders-Rhinitis allergic | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Surgical and medical procedures-Finger amputation | 0 Participants |
| UBX-1325 | Adverse Events (Safety) | Vascular disorders-Hypotension | 1 Participants |
| UBX-1325 | Adverse Events (Safety) | Vascular disorders-Hypertension | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Injury, poisoning and procedural complications-Facial bones fracture | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Injury, poisoning and procedural complications-Radius fracture | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Gastrointestinal disorders-Gingival recession | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Injury, poisoning and procedural complications-Rib fracture | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Vascular disorders-Hypotension | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Injury, poisoning and procedural complications-Scapula fracture | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Gastrointestinal disorders-Hiatus hernia | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Injury, poisoning and procedural complications-Thoracic vertebral fracture | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Injury, poisoning and procedural complications-Femur fracture | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Injury, poisoning and procedural complications-Wrist fracture | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Gastrointestinal disorders-Large intestine polyp | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Investigations-Heart rate irregular | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Psychiatric disorders-Insomnia | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Investigations-Electrocardiogram QRS complex abnormal | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Gastrointestinal disorders-Retroperitoneal haemorrhage | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Investigations-QRS axis abnormal | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Injury, poisoning and procedural complications-Fibula fracture | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Metabolism and nutrition disorders-Dehydration | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Gastrointestinal disorders-Toothache | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Metabolism and nutrition disorders-Hypokalaemia | 2 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Metabolism and nutrition disorders-Hyperlipidaemia | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Gastrointestinal disorders-Vomiting | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Subjects with At Least One TEAE | 20 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Respiratory, thoracic and mediastinal disorders-Mediastinal haematoma | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Blood and lymphatic system disorders-Anaemia | 2 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | General disorders and administration site conditions-Oedema peripheral | 2 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Cardiac disorders-Atrial fibrillation | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Metabolism and nutrition disorders-Hypoglycaemia | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Cardiac disorders-Angina unstable | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | General disorders and administration site conditions-Asthenia | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Cardiac disorders-Arrhythmia supraventricular | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Renal and urinary disorders-Acute kidney injury | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Cardiac disorders-Cardiac failure congestive | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | General disorders and administration site conditions-Influenza like illness | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Cardiac disorders-Coronary artery disease | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Metabolism and nutrition disorders-Hypomagnesaemia | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Cardiac disorders-Ventricular extrasystoles | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | General disorders and administration site conditions-Multiple organ dysfunction syndrome | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Congenital, familial and genetic disorders-Hydrocele | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Surgical and medical procedures-Finger amputation | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Ear and labyrinth disorders-Vertigo | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | General disorders and administration site conditions-Pain | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Endocrine disorders-Hypothyroidism | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Metabolism and nutrition disorders-Hypovolaemia | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Neovascular age-related macular degeneration | 7 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Infections and infestations-Urinary tract infection | 2 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Conjunctival haemorrhage | 8 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Renal and urinary disorders-Nephropathy | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Retinal haemorrhage | 3 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Infections and infestations-COVID-19 | 2 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Macular oedema | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Musculoskeletal and connective tissue disorders-Arthritis | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Macular thickening | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Infections and infestations-Nasopharyngitis | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Dry eye | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Respiratory, thoracic and mediastinal disorders-Respiratory failure | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Punctate keratitis | 2 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Infections and infestations-Bacteraemia | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Subretinal fluid | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Musculoskeletal and connective tissue disorders-Rhabdomyolysis | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Visual acuity reduced | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Infections and infestations-Fungal infection | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Blepharitis | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Renal and urinary disorders-Renal haematoma | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Cataract | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Infections and infestations-Gastrointestinal bacterial infection | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Lacrimation increased | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Meningioma | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Macular degeneration | 2 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Infections and infestations-Paronychia | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Optic nerve sheath haemorrhage | 2 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Vascular disorders-Hypertension | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Retinal exudates | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Infections and infestations-Pneumonia | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Retinal oedema | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Rectal cancer stage III | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Vitreous haemorrhage | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Infections and infestations-Urosepsis | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Blindness unilateral | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Respiratory, thoracic and mediastinal disorders-Asthma | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Cataract cortical | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Infections and infestations-Viral rhinitis | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Diabetic retinopathy | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Squamous cell carcinoma | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Macular detachment | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Injury, poisoning and procedural complications-Fall | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Pinguecula | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Respiratory, thoracic and mediastinal disorders-Rhinitis allergic | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Eye disorders-Posterior capsule opacification | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Injury, poisoning and procedural complications-Skin laceration | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Uveitis | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Nervous system disorders-Carotid arteriosclerosis | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Visual impairment | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Injury, poisoning and procedural complications-Corneal abrasion | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Gastrointestinal disorders-Nausea | 2 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Respiratory, thoracic and mediastinal disorders-Chronic obstructive pulmonary disease | 0 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Gastrointestinal disorders-Constipation | 2 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Injury, poisoning and procedural complications-Crush injury | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Gastrointestinal disorders-Gastrooesophageal reflux disease | 2 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Product issues-Device dislocation | 1 Participants |
| EYLEA® (Aflibercept) | Adverse Events (Safety) | Gastrointestinal disorders-Dyspepsia | 1 Participants |
Secondary
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart starting at 4 meters.
Time frame: Through 48 weeks
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| UBX-1325 | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 20 | 0.7 ETDRS Letters | Standard Error 1.96 |
| UBX-1325 | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 48 | -1.5 ETDRS Letters | Standard Error 3.24 |
| UBX-1325 | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 24 | 0.1 ETDRS Letters | Standard Error 2.25 |
| UBX-1325 | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 8 | 0.6 ETDRS Letters | Standard Error 1.36 |
| UBX-1325 | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 28 | -0.5 ETDRS Letters | Standard Error 1.86 |
| UBX-1325 | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 2 | -0.2 ETDRS Letters | Standard Error 1.99 |
| UBX-1325 | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 32 | -2.4 ETDRS Letters | Standard Error 1.99 |
| UBX-1325 | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 12 | 1.1 ETDRS Letters | Standard Error 1.37 |
| UBX-1325 | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 36 | -4.1 ETDRS Letters | Standard Error 2.91 |
| UBX-1325 | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Baseline | 58 ETDRS Letters | Standard Error 13.47 |
| UBX-1325 | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 40 | -4.9 ETDRS Letters | Standard Error 2.38 |
| UBX-1325 | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 16 | -1.9 ETDRS Letters | Standard Error 2.87 |
| UBX-1325 | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 44 | -0.5 ETDRS Letters | Standard Error 2.71 |
| UBX-1325 | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 4 | 1.7 ETDRS Letters | Standard Error 1.45 |
| EYLEA® (Aflibercept) | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 44 | 1.8 ETDRS Letters | Standard Error 1.63 |
| EYLEA® (Aflibercept) | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Baseline | 62.4 ETDRS Letters | Standard Error 9.46 |
| EYLEA® (Aflibercept) | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 2 | 3.1 ETDRS Letters | Standard Error 0.85 |
| EYLEA® (Aflibercept) | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 4 | 3.0 ETDRS Letters | Standard Error 1.08 |
| EYLEA® (Aflibercept) | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 8 | 3.2 ETDRS Letters | Standard Error 1.12 |
| EYLEA® (Aflibercept) | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 12 | 2.7 ETDRS Letters | Standard Error 1.5 |
| EYLEA® (Aflibercept) | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 16 | 2.2 ETDRS Letters | Standard Error 1.49 |
| EYLEA® (Aflibercept) | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 20 | 2.5 ETDRS Letters | Standard Error 1.69 |
| EYLEA® (Aflibercept) | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 24 | 2.2 ETDRS Letters | Standard Error 1.42 |
| EYLEA® (Aflibercept) | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 28 | 3.2 ETDRS Letters | Standard Error 1.56 |
| EYLEA® (Aflibercept) | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 32 | 2.1 ETDRS Letters | Standard Error 1.53 |
| EYLEA® (Aflibercept) | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 36 | 2.5 ETDRS Letters | Standard Error 1.43 |
| EYLEA® (Aflibercept) | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 40 | 3.4 ETDRS Letters | Standard Error 1.44 |
| EYLEA® (Aflibercept) | Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time | Week 48 | 1.7 ETDRS Letters | Standard Error 1.73 |
Secondary
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
Central Subfield Thickness (CST) measured in microns using spectral domain optical coherence tomography (SD-OCT).
Time frame: Through 48 weeks
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| UBX-1325 | 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 |
| EYLEA® (Aflibercept) | 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 | -29.4 Microns | Standard Error 17.29 |
| EYLEA® (Aflibercept) | 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 | 367.5 Microns | Standard Error 151.75 |
| EYLEA® (Aflibercept) | 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 | 31.7 Microns | Standard Error 9.57 |
| EYLEA® (Aflibercept) | 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 | -35.0 Microns | Standard Error 6.5 |
| EYLEA® (Aflibercept) | 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 | -23.3 Microns | Standard Error 7.77 |
| EYLEA® (Aflibercept) | 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 | -14.9 Microns | Standard Error 5.89 |
| EYLEA® (Aflibercept) | 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 | -6.4 Microns | Standard Error 8.33 |
| EYLEA® (Aflibercept) | 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 | 15.2 Microns | Standard Error 8.55 |
| EYLEA® (Aflibercept) | 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 | 23.3 Microns | Standard Error 10.77 |
| EYLEA® (Aflibercept) | 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 | -18.0 Microns | Standard Error 8.72 |
| EYLEA® (Aflibercept) | 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 | 26.4 Microns | Standard Error 9.72 |
| EYLEA® (Aflibercept) | 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 | 22.2 Microns | Standard Error 10.14 |
| EYLEA® (Aflibercept) | 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 | 28.2 Microns | Standard Error 10.25 |
| EYLEA® (Aflibercept) | 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 | -16.4 Microns | Standard Error 7.82 |