Trial Outcomes & Findings for Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema (NCT NCT04697758)
NCT ID: NCT04697758
Last Updated: 2024-03-22
Results Overview
Incidence of ocular (study eye) and systemic AEs
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Screening to Week 48
Results posted on
2024-03-22
Participant Flow
No participants were assigned to the "High Dose" Arm/Group" due to adverse events observed in the "Low Dose" and "Mid Dose" groups.
Participant milestones
| Measure |
Low Dose
AXT107 0.1 mg/eye
AXT107 0.1 mg: Single intravitreal injection of AXT107 0.1 mg/eye
|
Mid Dose
AXT107 0.25 mg/eye
AXT107 0.25 mg: Single intravitreal injection of AXT107 0.25 mg/eye
|
High Dose
AXT107 0.5 mg/eye
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
3
|
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 Diabetic Macular Edema
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
|
Mid Dose
n=3 Participants
AXT107 0.25 mg/eye
AXT107 0.25 mg: Single intravitreal injection of AXT107 0.25 mg/eye
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
58.3 years
n=5 Participants
|
73.3 years
n=7 Participants
|
65.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening to Week 48Incidence of ocular (study eye) and systemic 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
|
Mid Dose
n=3 Participants
AXT107 0.25 mg/eye
AXT107 0.25 mg: Single intravitreal injection of AXT107 0.25 mg/eye
|
|---|---|---|
|
Safety as Assessed by Incidence of Adverse Events (AEs)
Serious Ocular Adverse Event Treatment Related
|
2 Participants
|
1 Participants
|
|
Safety as Assessed by Incidence of Adverse Events (AEs)
Serious Non-Ocular Adverse Event Not Related to treatment
|
1 Participants
|
0 Participants
|
Adverse Events
Low Dose
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Mid Dose
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious 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
|
Mid Dose
n=3 participants at risk
AXT107 0.25 mg/eye
AXT107 0.25 mg: Single intravitreal injection of AXT107 0.25 mg/eye
|
|---|---|---|
|
Eye disorders
Ocular Hypertension
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
|
Eye disorders
Glaucoma
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
|
Infections and infestations
Gastroenteritis
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
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
|
Mid Dose
n=3 participants at risk
AXT107 0.25 mg/eye
AXT107 0.25 mg: Single intravitreal injection of AXT107 0.25 mg/eye
|
|---|---|---|
|
Eye disorders
Vitreous Floaters
|
66.7%
2/3 • Number of events 3 • 48 weeks
|
33.3%
1/3 • Number of events 3 • 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place