Trial Outcomes & Findings for A Single Ascending Dose Cohort Study of AG-73305 in DME Patients (NCT NCT05301751)
NCT ID: NCT05301751
Last Updated: 2025-10-15
Results Overview
BCVA assessments were performed at all visits utilizing ETDRS charts to assess changes in vision over time. The charts were designed for use at 4 meters. BCVA assessments were performed by certified technicians to minimize bias.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
1 month after dosing
Results posted on
2025-10-15
Participant Flow
Patients were screened based on the inclusion/exclusion criteria at 6 clinical sites in the US between May 2022 to December 2023.
Participant milestones
| Measure |
Cohort 1
A single intravitreal (IVT) dose of 0.5 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Cohort 2
A single IVT dose of 1 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Cohort 3
A single IVT dose of 2 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Cohort 4
A single IVT dose of 4 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
8
|
8
|
|
Overall Study
COMPLETED
|
3
|
6
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
A single intravitreal (IVT) dose of 0.5 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Cohort 2
A single IVT dose of 1 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Cohort 3
A single IVT dose of 2 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Cohort 4
A single IVT dose of 4 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Single Ascending Dose Cohort Study of AG-73305 in DME Patients
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
A single intravitreal (IVT) dose of 0.5 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Cohort 2
n=6 Participants
A single IVT dose of 1 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Cohort 3
n=8 Participants
A single IVT dose of 2 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Cohort 4
n=8 Participants
A single IVT dose of 4 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Total
n=25 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 14.7 • n=4 Participants
|
60.3 years
STANDARD_DEVIATION 12.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
25 participants
n=21 Participants
|
|
Best-corrected Visual Acuity
|
56.7 ETDRS letters
STANDARD_DEVIATION 1.5 • n=5 Participants
|
48.7 ETDRS letters
STANDARD_DEVIATION 11.9 • n=7 Participants
|
62.4 ETDRS letters
STANDARD_DEVIATION 5.4 • n=5 Participants
|
63.0 ETDRS letters
STANDARD_DEVIATION 3.2 • n=4 Participants
|
58.6 ETDRS letters
STANDARD_DEVIATION 8.8 • n=21 Participants
|
|
Central Subfield Thickness
|
522.017 micrometers
STANDARD_DEVIATION 197.845 • n=5 Participants
|
657.732 micrometers
STANDARD_DEVIATION 169.990 • n=7 Participants
|
444.818 micrometers
STANDARD_DEVIATION 163.635 • n=5 Participants
|
464.488 micrometers
STANDARD_DEVIATION 140.934 • n=4 Participants
|
511.475 micrometers
STANDARD_DEVIATION 174.539 • n=21 Participants
|
PRIMARY outcome
Timeframe: 1 month after dosingBCVA assessments were performed at all visits utilizing ETDRS charts to assess changes in vision over time. The charts were designed for use at 4 meters. BCVA assessments were performed by certified technicians to minimize bias.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
A single intravitreal (IVT) dose of 0.5 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Cohort 2
n=6 Participants
A single IVT dose of 1 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Cohort 3
n=8 Participants
A single IVT dose of 2 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Cohort 4
n=8 Participants
A single IVT dose of 4 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
|---|---|---|---|---|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
|
3.7 ETDRS letters
Standard Deviation 1.2
|
9.2 ETDRS letters
Standard Deviation 5.3
|
4.3 ETDRS letters
Standard Deviation 3.9
|
7.7 ETDRS letters
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: 1 month after dosingSD-OCT imaging was performed at all visits utilizing Heidelberg Spectralis imaging equipment to assess changes over time in the structural details of the posterior segment of the eye. All images were graded by a central reading center.
Outcome measures
| Measure |
Cohort 1
n=3 eyes
A single intravitreal (IVT) dose of 0.5 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Cohort 2
n=6 eyes
A single IVT dose of 1 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Cohort 3
n=8 eyes
A single IVT dose of 2 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
Cohort 4
n=8 eyes
A single IVT dose of 4 mg AG-73305
AG-73305: AG-73305 Ophthalmic Solution
|
|---|---|---|---|---|
|
Mean Change From Baseline in Central Subfield Thickness (CST)
|
2.287 μm
Standard Deviation 9.819
|
-263.167 μm
Standard Deviation 221.986
|
-70.443 μm
Standard Deviation 175.147
|
-50.571 μm
Standard Deviation 108.694
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 4
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=3 participants at risk
A single intravitreal (IVT) dose of 0.5 mg AG-73305
|
Cohort 2
n=6 participants at risk
A single IVT dose of 1 mg AG-73305
|
Cohort 3
n=8 participants at risk
A single IVT dose of 2 mg AG-73305
|
Cohort 4
n=8 participants at risk
A single IVT dose of 4 mg AG-73305
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/3 • 6 months (24 weeks)
|
0.00%
0/6 • 6 months (24 weeks)
|
0.00%
0/8 • 6 months (24 weeks)
|
12.5%
1/8 • Number of events 1 • 6 months (24 weeks)
|
|
Renal and urinary disorders
Kidney failure
|
0.00%
0/3 • 6 months (24 weeks)
|
0.00%
0/6 • 6 months (24 weeks)
|
12.5%
1/8 • Number of events 1 • 6 months (24 weeks)
|
—
0/0 • 6 months (24 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure with hypoxia
|
0.00%
0/3 • 6 months (24 weeks)
|
0.00%
0/6 • 6 months (24 weeks)
|
12.5%
1/8 • Number of events 1 • 6 months (24 weeks)
|
—
0/0 • 6 months (24 weeks)
|
|
Cardiac disorders
Congestive heart failure excerbation
|
0.00%
0/3 • 6 months (24 weeks)
|
0.00%
0/6 • 6 months (24 weeks)
|
12.5%
1/8 • Number of events 1 • 6 months (24 weeks)
|
12.5%
1/8 • Number of events 1 • 6 months (24 weeks)
|
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
A single intravitreal (IVT) dose of 0.5 mg AG-73305
|
Cohort 2
n=6 participants at risk
A single IVT dose of 1 mg AG-73305
|
Cohort 3
n=8 participants at risk
A single IVT dose of 2 mg AG-73305
|
Cohort 4
n=8 participants at risk
A single IVT dose of 4 mg AG-73305
|
|---|---|---|---|---|
|
Eye disorders
Iridocyclitis (drug related)
|
66.7%
2/3 • Number of events 2 • 6 months (24 weeks)
|
66.7%
4/6 • Number of events 4 • 6 months (24 weeks)
|
37.5%
3/8 • Number of events 4 • 6 months (24 weeks)
|
50.0%
4/8 • Number of events 6 • 6 months (24 weeks)
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/3 • 6 months (24 weeks)
|
16.7%
1/6 • Number of events 1 • 6 months (24 weeks)
|
12.5%
1/8 • Number of events 1 • 6 months (24 weeks)
|
25.0%
2/8 • Number of events 2 • 6 months (24 weeks)
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/3 • 6 months (24 weeks)
|
16.7%
1/6 • Number of events 1 • 6 months (24 weeks)
|
0.00%
0/8 • 6 months (24 weeks)
|
25.0%
2/8 • Number of events 2 • 6 months (24 weeks)
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/3 • 6 months (24 weeks)
|
0.00%
0/6 • 6 months (24 weeks)
|
25.0%
2/8 • Number of events 2 • 6 months (24 weeks)
|
0.00%
0/8 • 6 months (24 weeks)
|
|
Eye disorders
anterior chamber inflammation
|
33.3%
1/3 • Number of events 1 • 6 months (24 weeks)
|
0.00%
0/6 • 6 months (24 weeks)
|
0.00%
0/8 • 6 months (24 weeks)
|
0.00%
0/8 • 6 months (24 weeks)
|
|
Eye disorders
Iridocylitis
|
0.00%
0/3 • 6 months (24 weeks)
|
0.00%
0/6 • 6 months (24 weeks)
|
12.5%
1/8 • Number of events 1 • 6 months (24 weeks)
|
25.0%
2/8 • Number of events 2 • 6 months (24 weeks)
|
Additional Information
Tan Nguyen, Vice President of R&D
Allgenesis Biotherapeutics Inc.
Phone: +886-2-87871232
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place