Trial Outcomes & Findings for Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (NCT NCT02358889)
NCT ID: NCT02358889
Last Updated: 2020-09-24
Results Overview
Best corrected visual acuity (BCVA) was measured pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS) retro illuminated charts. The BCVA was recorded as the total letter score in each eye.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
88 participants
Primary outcome timeframe
Baseline and Month 3
Results posted on
2020-09-24
Participant Flow
Participant milestones
| Measure |
hI-con1
Patients will receive monthly intravitreal hI-con1 as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
hI-con1 + Ranibizumab
Patients will receive monthly intravitreal hI-con1 in combination with intravitreal ranibizumab for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
|
Ranibizumab
Patients will receive monthly intravitreal ranibizumab as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
28
|
|
Overall Study
COMPLETED
|
30
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Baseline characteristics by cohort
| Measure |
hI-con1
n=30 Participants
Patients will receive monthly intravitreal hI-con1 as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
hI-con1 + Ranibizumab
n=30 Participants
Patients will receive monthly intravitreal hI-con1 in combination with intravitreal ranibizumab for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
|
Ranibizumab
n=28 Participants
Patients will receive monthly intravitreal ranibizumab as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
74.4 years
STANDARD_DEVIATION 10.65 • n=5 Participants
|
78.4 years
STANDARD_DEVIATION 9.92 • n=7 Participants
|
78.8 years
STANDARD_DEVIATION 7.19 • n=5 Participants
|
77.1 years
STANDARD_DEVIATION 9.52 • n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
28 participants
n=5 Participants
|
88 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 3Best corrected visual acuity (BCVA) was measured pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS) retro illuminated charts. The BCVA was recorded as the total letter score in each eye.
Outcome measures
| Measure |
hI-con1
n=29 Participants
Patients will receive monthly intravitreal hI-con1 as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
hI-con1 + Ranibizumab
n=30 Participants
Patients will receive monthly intravitreal hI-con1 in combination with intravitreal ranibizumab for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
|
Ranibizumab
n=27 Participants
Patients will receive monthly intravitreal ranibizumab as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
|---|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3
|
.3 Letters
Standard Deviation 7.76
|
6.8 Letters
Standard Deviation 8.21
|
7.6 Letters
Standard Deviation 7.05
|
PRIMARY outcome
Timeframe: Baseline and Month 3Optical Coherence Tomography (OCT) imaging was performed pre treatment during visits in which study treatment was administered and to assess lesion characteristics for the study eye. and were evaluated by a central reading center for standardized grading.
Outcome measures
| Measure |
hI-con1
n=29 Participants
Patients will receive monthly intravitreal hI-con1 as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
hI-con1 + Ranibizumab
n=30 Participants
Patients will receive monthly intravitreal hI-con1 in combination with intravitreal ranibizumab for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
|
Ranibizumab
n=27 Participants
Patients will receive monthly intravitreal ranibizumab as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
|---|---|---|---|
|
Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3
|
53.9 Microns
Standard Deviation 17.01
|
66.3 Microns
Standard Deviation 10.95
|
64.9 Microns
Standard Deviation 27
|
SECONDARY outcome
Timeframe: Baseline and Month 6Best corrected visual acuity (BCVA) was measured pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS) retro illuminated charts. The BCVA was recorded as the total letter score in each eye.
Outcome measures
| Measure |
hI-con1
n=29 Participants
Patients will receive monthly intravitreal hI-con1 as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
hI-con1 + Ranibizumab
n=30 Participants
Patients will receive monthly intravitreal hI-con1 in combination with intravitreal ranibizumab for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
|
Ranibizumab
n=27 Participants
Patients will receive monthly intravitreal ranibizumab as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
|---|---|---|---|
|
Change From Baseline in BCVA in the Study Eye at Month 6
|
-2.1 Letters
Standard Deviation 8.05
|
8.4 Letters
Standard Deviation 10.14
|
8.3 Letters
Standard Deviation 9.10
|
SECONDARY outcome
Timeframe: Baseline and Month 6Central Retinal Subfield Thickness (CST) as measured by Optical Coherence Tomography (OCT). The change from the baseline measurement was compared to the month 6 measurement.
Outcome measures
| Measure |
hI-con1
n=29 Participants
Patients will receive monthly intravitreal hI-con1 as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
hI-con1 + Ranibizumab
n=30 Participants
Patients will receive monthly intravitreal hI-con1 in combination with intravitreal ranibizumab for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
|
Ranibizumab
n=27 Participants
Patients will receive monthly intravitreal ranibizumab as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
|---|---|---|---|
|
Change From Baseline in CST in the Study Eye at Month 6
|
-35.7 Microns
Standard Deviation 71.52
|
-83.9 Microns
Standard Deviation 71.52
|
-91.4 Microns
Standard Deviation 137.10
|
Adverse Events
hI-con1
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
hI-con1 + Ranibizumab
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Ranibizumab
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
hI-con1
n=30 participants at risk
Patients will receive monthly intravitreal hI-con1 as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
hI-con1 + Ranibizumab
n=30 participants at risk
Patients will receive monthly intravitreal hI-con1 in combination with intravitreal ranibizumab for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
|
Ranibizumab
n=28 participants at risk
Patients will receive monthly intravitreal ranibizumab as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
10.7%
3/28 • Number of events 3
|
|
Cardiac disorders
Atrial Fibrillation
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
0.00%
0/28
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
0.00%
0/28
|
|
Infections and infestations
Cellulitis
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
0.00%
0/28
|
|
Infections and infestations
Pleural Effusion
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
0.00%
0/28
|
|
Infections and infestations
Subcutaneous abscess
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
0.00%
0/28
|
|
General disorders
Vertigo Positional
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
0.00%
0/28
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/30
|
0.00%
0/30
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/30
|
0.00%
0/30
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/30
|
0.00%
0/30
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/30
|
0.00%
0/30
|
3.6%
1/28 • Number of events 1
|
|
Reproductive system and breast disorders
Prostate Cancer
|
0.00%
0/30
|
0.00%
0/30
|
3.6%
1/28 • Number of events 1
|
Other adverse events
| Measure |
hI-con1
n=30 participants at risk
Patients will receive monthly intravitreal hI-con1 as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
hI-con1 + Ranibizumab
n=30 participants at risk
Patients will receive monthly intravitreal hI-con1 in combination with intravitreal ranibizumab for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
hI-con1: Intravitreal injection of hI-con1 0.3 mg
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
|
Ranibizumab
n=28 participants at risk
Patients will receive monthly intravitreal ranibizumab as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
ranibizumab: Intravitreal injection of ranibizumab 0.5 mg
Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
|
|---|---|---|---|
|
Eye disorders
Conjunctival Haemorrhge
|
13.3%
4/30 • Number of events 4
|
26.7%
8/30 • Number of events 8
|
14.3%
4/28 • Number of events 4
|
|
Eye disorders
Vitreous Floaters
|
13.3%
4/30 • Number of events 4
|
13.3%
4/30 • Number of events 4
|
10.7%
3/28 • Number of events 3
|
|
Eye disorders
Eye Pain
|
3.3%
1/30 • Number of events 1
|
23.3%
7/30 • Number of events 7
|
3.6%
1/28 • Number of events 1
|
|
Eye disorders
Retinal Haemorrhage
|
26.7%
8/30 • Number of events 8
|
3.3%
1/30 • Number of events 1
|
0.00%
0/28
|
|
Eye disorders
Eye Irritation
|
6.7%
2/30 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
0.00%
0/28
|
|
Eye disorders
Vision Blurred
|
6.7%
2/30 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
0.00%
0/28
|
|
Eye disorders
Vitreous Detachment
|
0.00%
0/30
|
6.7%
2/30 • Number of events 2
|
7.1%
2/28 • Number of events 2
|
|
Eye disorders
Blepharitis
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
7.1%
2/28 • Number of events 2
|
|
Eye disorders
Conjunctival Oedema
|
0.00%
0/30
|
6.7%
2/30 • Number of events 2
|
0.00%
0/28
|
|
Eye disorders
Punctate Keratitis
|
0.00%
0/30
|
6.7%
2/30 • Number of events 2
|
0.00%
0/28
|
|
Eye disorders
Increased Intraocular Pressure
|
16.7%
5/30 • Number of events 5
|
6.7%
2/30 • Number of events 2
|
0.00%
0/28
|
|
Eye disorders
Abnormal Visual Acuity Test
|
16.7%
5/30 • Number of events 5
|
6.7%
2/30 • Number of events 2
|
0.00%
0/28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place