Trial Outcomes & Findings for Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD) (NCT NCT03452527)
NCT ID: NCT03452527
Last Updated: 2021-04-13
Results Overview
Mean change from baseline in CNV area in the study eye
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Month 9
Results posted on
2021-04-13
Participant Flow
Participant milestones
| Measure |
ICON-1 Maintenance Therapy
ICON-1 maintenance therapy after initial aflibercept treatment
ICON-1: ICON-1 0.6 mg by intravitreal injection
aflibercept: aflibercept 2 mg by intravitreal injection
|
ICON-1 Combination Therapy
ICON-1 combination therapy with aflibercept treatment
ICON-1: ICON-1 0.6 mg by intravitreal injection
aflibercept: aflibercept 2 mg by intravitreal injection
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
ICON-1 Maintenance Therapy
ICON-1 maintenance therapy after initial aflibercept treatment
ICON-1: ICON-1 0.6 mg by intravitreal injection
aflibercept: aflibercept 2 mg by intravitreal injection
|
ICON-1 Combination Therapy
ICON-1 combination therapy with aflibercept treatment
ICON-1: ICON-1 0.6 mg by intravitreal injection
aflibercept: aflibercept 2 mg by intravitreal injection
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Study Terminated
|
2
|
3
|
Baseline Characteristics
Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
ICON-1 Maintenance Therapy
n=7 Participants
ICON-1 maintenance therapy after initial aflibercept treatment
ICON-1: ICON-1 0.6 mg by intravitreal injection
aflibercept: aflibercept 2 mg by intravitreal injection
|
ICON-1 Combination Therapy
n=8 Participants
ICON-1 combination therapy with aflibercept treatment
ICON-1: ICON-1 0.6 mg by intravitreal injection
aflibercept: aflibercept 2 mg by intravitreal injection
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
50 to <65 Years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
65 to<75 Years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
75 to <85
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Customized
85 Years or older
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 9Population: The change in choroidal neovascularization by OCT-A, reported as assessed by the investigators. The changes did not correlate with the change in choroidal neovascularization by FA and therefore further analysis was not performed.
Mean change from baseline in CNV area in the study eye
Outcome measures
| Measure |
ICON-1 Maintenance Therapy
n=5 Participants
ICON-1 maintenance therapy after initial aflibercept treatment
ICON-1: ICON-1 0.6 mg by intravitreal injection
aflibercept: aflibercept 2 mg by intravitreal injection
|
ICON-1 Combination Therapy
n=8 Participants
ICON-1 combination therapy with aflibercept treatment
ICON-1: ICON-1 0.6 mg by intravitreal injection
aflibercept: aflibercept 2 mg by intravitreal injection
|
|---|---|---|
|
Change in Choroidal Neovascularization (CNV) Over Time
CNV Size-Smaller
|
2 participants
|
5 participants
|
|
Change in Choroidal Neovascularization (CNV) Over Time
CNV Size-No Change
|
2 participants
|
2 participants
|
|
Change in Choroidal Neovascularization (CNV) Over Time
CNV Size- Larger
|
0 participants
|
1 participants
|
|
Change in Choroidal Neovascularization (CNV) Over Time
CNV Size-Cannot Grade
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Month 9Population: Due to the small sample size and early termination of the study conclusions can not be accurately made from the available data.
Mean change from baseline in BCVA letter score in the study eye
Outcome measures
| Measure |
ICON-1 Maintenance Therapy
n=6 Participants
ICON-1 maintenance therapy after initial aflibercept treatment
ICON-1: ICON-1 0.6 mg by intravitreal injection
aflibercept: aflibercept 2 mg by intravitreal injection
|
ICON-1 Combination Therapy
n=8 Participants
ICON-1 combination therapy with aflibercept treatment
ICON-1: ICON-1 0.6 mg by intravitreal injection
aflibercept: aflibercept 2 mg by intravitreal injection
|
|---|---|---|
|
Change in Best Corrected Visual Acuity (BCVA) Over Time
|
1 Letters
Interval -2.0 to 7.0
|
0 Letters
Interval -3.0 to 5.0
|
Adverse Events
ICON-1 Maintenance Therapy
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
ICON-1 Combination Therapy
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ICON-1 Maintenance Therapy
n=7 participants at risk
ICON-1 maintenance therapy after initial aflibercept treatment
ICON-1: ICON-1 0.6 mg by intravitreal injection
aflibercept: aflibercept 2 mg by intravitreal injection
|
ICON-1 Combination Therapy
n=8 participants at risk
ICON-1 combination therapy with aflibercept treatment
ICON-1: ICON-1 0.6 mg by intravitreal injection
aflibercept: aflibercept 2 mg by intravitreal injection
|
|---|---|---|
|
Vascular disorders
Transient Ischemic Attach (TIA)
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
0.00%
0/8 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
0.00%
0/8 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Nervous system disorders
Metabolic Encephalopathy
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
Other adverse events
| Measure |
ICON-1 Maintenance Therapy
n=7 participants at risk
ICON-1 maintenance therapy after initial aflibercept treatment
ICON-1: ICON-1 0.6 mg by intravitreal injection
aflibercept: aflibercept 2 mg by intravitreal injection
|
ICON-1 Combination Therapy
n=8 participants at risk
ICON-1 combination therapy with aflibercept treatment
ICON-1: ICON-1 0.6 mg by intravitreal injection
aflibercept: aflibercept 2 mg by intravitreal injection
|
|---|---|---|
|
Eye disorders
Macular Fibrosis
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Photopsia
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Retinal Haemorrhage
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Subretinal Fluid
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
25.0%
2/8 • Number of events 2 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Choroidal Neovascularization
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Detachment of Retinal Pigment Epithelium
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Dry Age Related Macular Degeneration
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Dry eye
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
0.00%
0/8 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Eyelids Pruritus
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Lacrimation Increased
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
0.00%
0/8 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Macular Oedema
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Metamorphopsia
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
0.00%
0/8 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Optic Ischaemic Neuropathy
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Retinal Depigmentation
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Retinal Pigment Epithelial Tear
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
0.00%
0/8 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Visual Acuity Reduced
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
0.00%
0/8 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Visual lmpairement
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
0.00%
0/8 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Vitreous Detachment
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Vitreous Haemorrhage
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
0.00%
0/8 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Intraocular Pressure Increased
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
25.0%
2/8 • Number of events 2 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Gastrointestinal disorders
Gastritis
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
0.00%
0/8 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
0.00%
0/8 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Eye disorders
Vomiting
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
General disorders
Asthenia
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Immune system disorders
Drug Hypersensitivity
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
0.00%
0/8 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
25.0%
2/8 • Number of events 2 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
25.0%
2/8 • Number of events 2 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Infections and infestations
Cystitis
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
0.00%
0/8 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Infections and infestations
Genital Herpes
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Infections and infestations
Wound Infection
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
0.00%
0/8 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
|
Injury, poisoning and procedural complications
Laceration
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
0.00%
0/8 • Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place