Trial Outcomes & Findings for Safety and Tolerability Study for Age-Related Macular Degeneration (NCT NCT01485588)
NCT ID: NCT01485588
Last Updated: 2020-11-06
Results Overview
The Mean Change in Central Retinal Subfield Thickness as Measured by OCT is part of the evaluation on the safety and tolerability of single ascending doses of hI-con1 and to assist in determining the Maximum Tolerated Dose (MTD) that can be administered by intravitreal injection.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
24 Weeks
Results posted on
2020-11-06
Participant Flow
Participant milestones
| Measure |
hI-con1™ 60µg
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
|
hI-con1™ 150µg
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
|
hI-con1™ 300µg
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability Study for Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
hI-con1™ 60µg
n=6 Participants
This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
|
hI-con1™ 150µg
n=6 Participants
This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
|
hI-con1™ 300µg
n=6 Participants
This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
|
Total
n=18 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
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
18 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksThe Mean Change in Central Retinal Subfield Thickness as Measured by OCT is part of the evaluation on the safety and tolerability of single ascending doses of hI-con1 and to assist in determining the Maximum Tolerated Dose (MTD) that can be administered by intravitreal injection.
Outcome measures
| Measure |
hI-con1™ 60µg
n=6 Participants
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
|
hI-con1™ 150µg
n=6 Participants
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
|
hI-con1™ 300µg
n=6 Participants
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
|
|---|---|---|---|
|
Mean Change in Central Retinal Subfield Thickness as Measured by Optical Coherence Tomography (OCT) at Week 24 From Baseline
|
-98 Microns
Standard Deviation 141.19
|
-66 Microns
Standard Deviation 42.03
|
-180.8 Microns
Standard Deviation 97.9
|
PRIMARY outcome
Timeframe: 24 WeeksThe Mean Change in Best Corrected Visual Acuity (BCVA) is part of the evaluation on the safety and tolerability of single ascending doses of hI-con1 and to assist in determining the Maximum Tolerated Dose (MTD) that can be administered by intravitreal injection. BCVA is measured using the Early Diabetic Retinopathy Study (EDTRS) chart. More letters read result in a higher score.
Outcome measures
| Measure |
hI-con1™ 60µg
n=6 Participants
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
|
hI-con1™ 150µg
n=6 Participants
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
|
hI-con1™ 300µg
n=6 Participants
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
|
|---|---|---|---|
|
Mean Change in Best Corrected Visual Acuity (BCVA) at Week 24 From Baseline
|
-9.3 Letters
Standard Deviation 6.81
|
6.0 Letters
Standard Deviation 1.00
|
15.7 Letters
Standard Deviation 5.03
|
Adverse Events
hI-con1™ 300µg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
hI-con1™ 60µg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
hI-con1™ 150µg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
hI-con1™ 300µg
n=6 participants at risk
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
|
hI-con1™ 60µg
n=6 participants at risk
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
|
hI-con1™ 150µg
n=6 participants at risk
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
|
|---|---|---|---|
|
Cardiac disorders
Premature Atrial Contractions
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
Other adverse events
| Measure |
hI-con1™ 300µg
n=6 participants at risk
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
|
hI-con1™ 60µg
n=6 participants at risk
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
|
hI-con1™ 150µg
n=6 participants at risk
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
|
|---|---|---|---|
|
Eye disorders
Anterior Chamber Cell
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
|
Eye disorders
Blepharitis
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Conjunctival Haemorrhage
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Eye disorders
ConjunctivalHyperaemia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Conjunctival Oedema
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Eye disorders
Corneal Epithelium Defect
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Detachment of Retinal Pigment Epithelium
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Eye Irritation
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Eye Pain
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Eye Pruritus
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Macular Degeneration
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Retinal Dystrophy
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Retinal Exudates
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Retinal Haemorrhage
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Retinal Pigment Epithelial Tear
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Subretinal Fibrosis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Vision Blurred
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Vitreous Floaters
|
33.3%
2/6 • Number of events 3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Vitritis
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place