Trial Outcomes & Findings for Safety and Preliminary Efficacy Study of WST11 (Stakel®)-Mediated VTP Therapy in Subjects With CNV Associated With AMD (NCT NCT01021956)
NCT ID: NCT01021956
Last Updated: 2018-09-17
Results Overview
Adverse events (AEs) consisting in Eye disorders, related or non related were collected throughout the study.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
12 week follow-up
Results posted on
2018-09-17
Participant Flow
Participant milestones
| Measure |
Group 1a -2.5 mg/kg STAKEL - 25 J/cm²
2.5 mg/kg dose of STAKEL - 25 Joules/cm² of laser light at 753 nm
|
Group 1b-2.5 mg/kg STAKEL - 12.6 J/cm²
2.5 mg/kg dose of STAKEL -12.6 Joules/cm² of laser light at 753 nm
|
Group 1c-2.5 mg/kg STAKEL - 18.9 J/cm²
2.5 mg/kg dose of STAKEL -18.9 Joules/cm² of laser light at 753 nm
|
Group 2-2.5 mg/kg STAKEL - 50 J/cm²
2.5 mg/kg dose of STAKEL - 50 Joules/cm² of laser light at 753 nm
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Preliminary Efficacy Study of WST11 (Stakel®)-Mediated VTP Therapy in Subjects With CNV Associated With AMD
Baseline characteristics by cohort
| Measure |
Group 1a
n=3 Participants
2.5 mg/kg - 25 Joules/cm²
|
Group 1b
n=3 Participants
2.5 mg/kg - 12.6 Joules/cm²
|
Group 1c
n=3 Participants
2.5 mg/kg - 18.9 Joules/cm²
|
Group 2
n=1 Participants
2.5 mg/kg - 50 Joules/cm²
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70.30 years
STANDARD_DEVIATION 7.51 • n=99 Participants
|
78.3 years
STANDARD_DEVIATION 6.11 • n=107 Participants
|
81.00 years
STANDARD_DEVIATION 6.08 • n=206 Participants
|
87.00 years
STANDARD_DEVIATION 0 • n=7 Participants
|
77.60 years
STANDARD_DEVIATION 7.78 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Ethnicity (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: 12 week follow-upPopulation: The safety analysis set included all subjects with a signed informed consent form who received study treatment
Adverse events (AEs) consisting in Eye disorders, related or non related were collected throughout the study.
Outcome measures
| Measure |
Group 1a
n=3 Participants
2.5 mg/kg - 25 Joules/cm²
|
Group 1b
n=3 Participants
2.5 mg/kg - 12.6 Joules/cm²
|
Group 1c
n=3 Participants
2.5 mg/kg - 18.9 Joules/cm²
|
Group 2
n=1 Participants
2.5 mg/kg - 50 Joules/cm²
|
Overall
n=10 Participants
All doses of TOOKAD Soluble and Laser Light
|
|---|---|---|---|---|---|
|
Adverse Events (AEs) - Number of Subjects With Eye Disorders
|
3 participants
|
1 participants
|
0 participants
|
1 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Week 12.Population: Although STAKEL® VTP procedure induced effective neovessels occlusion in some patients, as observed in the previous study (study MLT 2.01 ), due to the small number of patients treated and the early termination of the study, limited efficacy data is available and no efficacy conclusion can be drown from this study.
Variation from baseline to week 12 in visual acuity score using Early Treatment Diabetic Retinopathy Study (ETDRS) 4.0 meter distance acuity chart. The patient is asked to read letter on a board from a distance of 4 meters. The charts use a geometric progression in letter size from line to line. The scores range from 0 (worse outcome) to 100/100 (best outcome)
Outcome measures
| Measure |
Group 1a
n=3 Participants
2.5 mg/kg - 25 Joules/cm²
|
Group 1b
n=3 Participants
2.5 mg/kg - 12.6 Joules/cm²
|
Group 1c
n=3 Participants
2.5 mg/kg - 18.9 Joules/cm²
|
Group 2
n=1 Participants
2.5 mg/kg - 50 Joules/cm²
|
Overall
All doses of TOOKAD Soluble and Laser Light
|
|---|---|---|---|---|---|
|
Visual Acuity
|
2 score on a scale
Interval -20.0 to 22.0
|
-12 score on a scale
Interval -12.0 to 0.0
|
4 score on a scale
Interval -7.0 to 7.0
|
-33 score on a scale
Interval -33.0 to -33.0
|
—
|
POST_HOC outcome
Timeframe: Day 1;Week 1;Week 5;Week 12.Global safety assessment including record of all complications and AEs, loss of lines in BCVA, slit lamp findings, IOP(Intra Occular Pressure), and fundus findings. All ocular and non-ocular AEs must be assessed for severity and relationship to the investigational product. Of note: the primary end point only concern patient with eye disorders events.
Outcome measures
| Measure |
Group 1a
n=3 Participants
2.5 mg/kg - 25 Joules/cm²
|
Group 1b
n=3 Participants
2.5 mg/kg - 12.6 Joules/cm²
|
Group 1c
n=3 Participants
2.5 mg/kg - 18.9 Joules/cm²
|
Group 2
n=1 Participants
2.5 mg/kg - 50 Joules/cm²
|
Overall
All doses of TOOKAD Soluble and Laser Light
|
|---|---|---|---|---|---|
|
Number of Participants With Any Ocular or Non-ocular Adverse Events
|
3 participants
|
1 participants
|
0 participants
|
1 participants
|
—
|
Adverse Events
Group 1A
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 1B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 1C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1A
n=3 participants at risk
2.5 mg/kg - 25 Joules/cm²
|
Group 1B
n=3 participants at risk
2.5 mg/kg - 12.6 Joules/cm²
|
Group 1C
n=3 participants at risk
2.5 mg/kg - 18.9 Joules/cm²
|
Group 2
n=1 participants at risk
2.5 mg/kg - 50 Joules/cm²
|
|---|---|---|---|---|
|
Eye disorders
retinal vascular occlusion
|
33.3%
1/3 • Number of events 1 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
100.0%
1/1 • Number of events 1 • 12 weeks
systematic Assessment : Regular investigator assessment
|
Other adverse events
| Measure |
Group 1A
n=3 participants at risk
2.5 mg/kg - 25 Joules/cm²
|
Group 1B
n=3 participants at risk
2.5 mg/kg - 12.6 Joules/cm²
|
Group 1C
n=3 participants at risk
2.5 mg/kg - 18.9 Joules/cm²
|
Group 2
n=1 participants at risk
2.5 mg/kg - 50 Joules/cm²
|
|---|---|---|---|---|
|
Eye disorders
eye pain
|
33.3%
1/3 • Number of events 1 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/1 • 12 weeks
systematic Assessment : Regular investigator assessment
|
|
Eye disorders
Visual Acuty reduced
|
66.7%
2/3 • Number of events 2 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/1 • 12 weeks
systematic Assessment : Regular investigator assessment
|
|
Eye disorders
Conjunctival haemorrhage
|
33.3%
1/3 • Number of events 1 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/1 • 12 weeks
systematic Assessment : Regular investigator assessment
|
|
Eye disorders
Ocular hyperaemia
|
33.3%
1/3 • Number of events 1 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/1 • 12 weeks
systematic Assessment : Regular investigator assessment
|
|
Eye disorders
Retinal pigment epitheliopathy
|
33.3%
1/3 • Number of events 1 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/1 • 12 weeks
systematic Assessment : Regular investigator assessment
|
|
Eye disorders
macular ischaemia
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
33.3%
1/3 • Number of events 1 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
100.0%
1/1 • Number of events 1 • 12 weeks
systematic Assessment : Regular investigator assessment
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
100.0%
1/1 • Number of events 2 • 12 weeks
systematic Assessment : Regular investigator assessment
|
|
Eye disorders
Retinal oedema
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
0.00%
0/3 • 12 weeks
systematic Assessment : Regular investigator assessment
|
100.0%
1/1 • Number of events 2 • 12 weeks
systematic Assessment : Regular investigator assessment
|
Additional Information
Bertrand Gaillac International Project Leader
STEBA Biotech
Phone: +33 9 74 19 79 05
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60