Trial Outcomes & Findings for Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (NCT NCT04746963)
NCT ID: NCT04746963
Last Updated: 2024-03-22
Results Overview
Incidence of ocular (study eye) and systemic adverse events (AEs)
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Screening to Week 48
Results posted on
2024-03-22
Participant Flow
Participants in the "mid Dose" and "high Dose" arms were not enrolled due to adverse events observed in the "Low Dose" arm participants
Participant milestones
| Measure |
Low Dose
AXT107 0.1 mg/eye
AXT107 0.1 mg: Single intravitreal injection of AXT107 0.1 mg/eye (low dose)
|
Mid Dose
AXT107 0.25 mg/eye
|
High Dose Arm
AXT107 0.5 mg/eye
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
Low Dose
n=3 Participants
AXT107 0.1 mg/eye
AXT107 0.1 mg: Single intravitreal injection of AXT107 0.1 mg/eye (low dose)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
79 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening to Week 48Incidence of ocular (study eye) and systemic adverse events (AEs)
Outcome measures
| Measure |
Low Dose
n=3 Participants
AXT107 0.1 mg/eye
AXT107 0.1 mg: Single intravitreal injection of AXT107 0.1 mg/eye (low dose)
|
|---|---|
|
Number of Participants Assessed by Incidence of Adverse Events (AEs)
|
1 Participants
|
Adverse Events
Low Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose
n=3 participants at risk
AXT107 0.1 mg/eye
AXT107 0.1 mg: Single intravitreal injection of AXT107 0.1 mg/eye (low dose)
|
|---|---|
|
Nervous system disorders
Vision Blurred
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place