Trial Outcomes & Findings for A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration (NCT NCT02555306)
NCT ID: NCT02555306
Last Updated: 2020-01-14
Results Overview
BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of \[0, 97\] in ETDRS letters. An increase in BCVA indicates an improvement in the best corrected vision.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Baseline (Day1) and Day 90.
Results posted on
2020-01-14
Participant Flow
Participant milestones
| Measure |
0.5 mg of DE-122
Single intravitreal injection of Low Dose DE-122 Injectable Solution
|
1.0 mg of DE-122
Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution
|
2.0 mg of DE-122
Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution
|
4.0 mg of DE-122
Single intravitreal injection of High Dose DE-122 Injectable Solution
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
Baseline characteristics by cohort
| Measure |
0.5 mg of DE-122
n=3 Participants
Single intravitreal injection of Low Dose DE-122 Injectable Solution
|
1.0 mg of DE-122
n=3 Participants
Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution
|
2.0 mg of DE-122
n=3 Participants
Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution
|
4.0 mg of DE-122
n=3 Participants
Single intravitreal injection of High Dose DE-122 Injectable Solution
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 4.2 • n=99 Participants
|
73.7 years
STANDARD_DEVIATION 1.2 • n=107 Participants
|
74.0 years
STANDARD_DEVIATION 6.2 • n=206 Participants
|
84.0 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
74.3 years
STANDARD_DEVIATION 8.1 • n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day1) and Day 90.BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of \[0, 97\] in ETDRS letters. An increase in BCVA indicates an improvement in the best corrected vision.
Outcome measures
| Measure |
0.5 mg of DE-122
n=3 Participants
Single intravitreal injection of Low Dose DE-122 Injectable Solution
|
1.0 mg of DE-122
n=3 Participants
Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution
|
2.0 mg of DE-122
n=3 Participants
Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution
|
4.0 mg of DE-122
n=3 Participants
Single intravitreal injection of High Dose DE-122 Injectable Solution
|
|---|---|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90.
|
-1.3 ETDRS letters
Standard Deviation 2.1
|
2.7 ETDRS letters
Standard Deviation 5.0
|
1.0 ETDRS letters
Standard Deviation 7.9
|
3.3 ETDRS letters
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Baseline (Day1) and Day 90.Bioactivity measures include CST (μm) measured by SD-OCT. Bioactivity will be considered evident if a considerable decrease in CST is observed.
Outcome measures
| Measure |
0.5 mg of DE-122
n=3 Participants
Single intravitreal injection of Low Dose DE-122 Injectable Solution
|
1.0 mg of DE-122
n=3 Participants
Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution
|
2.0 mg of DE-122
n=3 Participants
Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution
|
4.0 mg of DE-122
n=3 Participants
Single intravitreal injection of High Dose DE-122 Injectable Solution
|
|---|---|---|---|---|
|
Change From Baseline in Central Subfield Thickness (CST) at Day 90.
|
-116.3 microns
Standard Deviation 194.9
|
62.7 microns
Standard Deviation 68.1
|
-36.0 microns
Standard Deviation 42.6
|
-111.3 microns
Standard Deviation 171.2
|
Adverse Events
0.5 mg of DE-122
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1.0 mg of DE-122
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2.0 mg of DE-122
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
4.0 mg of DE-122
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.5 mg of DE-122
n=3 participants at risk
Single intravitreal injection of Low Dose DE-122
|
1.0 mg of DE-122
n=3 participants at risk
Single intravitreal injection of Medium-Low Dose DE-122
|
2.0 mg of DE-122
n=3 participants at risk
Single intravitreal injection of Medium-High Dose DE-122
|
4.0 mg of DE-122
n=3 participants at risk
Single intravitreal injection of High Dose DE-122
|
|---|---|---|---|---|
|
Eye disorders
Deposit eye
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
33.3%
1/3 • Number of events 1 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
33.3%
1/3 • Number of events 1 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
|
Eye disorders
Hyphaema
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
33.3%
1/3 • Number of events 1 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
33.3%
1/3 • Number of events 2 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
33.3%
1/3 • Number of events 1 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
33.3%
1/3 • Number of events 1 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
33.3%
1/3 • Number of events 1 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
33.3%
1/3 • Number of events 1 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
33.3%
1/3 • Number of events 1 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
33.3%
1/3 • Number of events 1 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
33.3%
1/3 • Number of events 1 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
33.3%
1/3 • Number of events 1 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
33.3%
1/3 • Number of events 1 • From Visit 1 (Day 1) to Study Exit (Day 90)]
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place