Trial Outcomes & Findings for A Safety Study of Intravitreal PP-001 in Patients With Chronic, Non-Infectious Uveitis (NCT NCT03634475)
NCT ID: NCT03634475
Last Updated: 2024-10-09
Results Overview
To assess safety and tolerability of ascending doses of PP-001 in participants with chronic, non-infectious uveitis when administered as single intravitreal injection
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
40 days
Results posted on
2024-10-09
Participant Flow
Participant milestones
| Measure |
PP-001
Single intravitreal injection of 3 up to 4 doses of PP-001
PP-001: Drug - no placebo
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety Study of Intravitreal PP-001 in Patients With Chronic, Non-Infectious Uveitis
Baseline characteristics by cohort
| Measure |
PP-001
n=12 Participants
Single intravitreal injection of 3 up to 4 doses of PP-001
PP-001: Drug - no placebo
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
52 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Austria
|
12 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 40 daysTo assess safety and tolerability of ascending doses of PP-001 in participants with chronic, non-infectious uveitis when administered as single intravitreal injection
Outcome measures
| Measure |
PP-001
n=12 Participants
Single intravitreal injection of 3 up to 4 doses of PP-001
PP-001: Drug - no placebo
|
|---|---|
|
Evaluation of Safety and Tolerability by Determining Treatment Emergent Adverse Events
|
12 Participants
|
Adverse Events
PP-001
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PP-001
n=12 participants at risk
Single intravitreal injection of 3 up to 4 doses of PP-001
PP-001: Drug - no placebo
|
|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
33.3%
4/12 • Number of events 5 • 14 days prior to dosing and 40 days after dosing
|
|
Eye disorders
Anterior Chamber Cell
|
25.0%
3/12 • Number of events 4 • 14 days prior to dosing and 40 days after dosing
|
|
Eye disorders
Conjunctival hyperaemia
|
25.0%
3/12 • Number of events 3 • 14 days prior to dosing and 40 days after dosing
|
|
Eye disorders
Anterior chamber flare
|
16.7%
2/12 • Number of events 2 • 14 days prior to dosing and 40 days after dosing
|
|
Eye disorders
Eye irritation
|
16.7%
2/12 • Number of events 2 • 14 days prior to dosing and 40 days after dosing
|
|
Eye disorders
Ocular hyperaemia
|
16.7%
2/12 • Number of events 2 • 14 days prior to dosing and 40 days after dosing
|
|
Eye disorders
Punctate keratitis
|
16.7%
2/12 • Number of events 3 • 14 days prior to dosing and 40 days after dosing
|
|
Eye disorders
Conjunctival cyst
|
8.3%
1/12 • Number of events 1 • 14 days prior to dosing and 40 days after dosing
|
|
Eye disorders
Conjunctival oedema
|
8.3%
1/12 • Number of events 1 • 14 days prior to dosing and 40 days after dosing
|
|
Eye disorders
Corneal deposits
|
8.3%
1/12 • Number of events 1 • 14 days prior to dosing and 40 days after dosing
|
|
Eye disorders
Cystoid macular oedema
|
8.3%
1/12 • Number of events 3 • 14 days prior to dosing and 40 days after dosing
|
|
Eye disorders
Episcleritis
|
8.3%
1/12 • Number of events 1 • 14 days prior to dosing and 40 days after dosing
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place