Choroidal Neovascularization, Wet Macular Degeneration
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effects of repeated intravitreal injections of ICON-1 0.6 mg administered as maintenance therapy or in combination with aflibercept in patients with wet macular degeneration.
Interventions
BIOLOGICALICON-1
ICON-1 0.6 mg by intravitreal injection
BIOLOGICALaflibercept
aflibercept 2 mg by intravitreal injection
Sponsors
Iconic Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females of any race, ≥50 years of age * Active primary CNV secondary to AMD in the study eye
Exclusion criteria
* Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins * Any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months * Vitrectomy in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Choroidal Neovascularization (CNV) Over Time | Month 9 | Mean change from baseline in CNV area in the study eye |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) Over Time | Month 9 | Mean change from baseline in BCVA letter score in the study eye |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| 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 | 8 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study Terminated | 2 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | ICON-1 Maintenance Therapy | ICON-1 Combination Therapy | Total |
|---|---|---|---|
| Age, Customized 50 to <65 Years | 0 Participants | 1 Participants | 1 Participants |
| Age, Customized 65 to<75 Years | 1 Participants | 2 Participants | 3 Participants |
| Age, Customized 75 to <85 | 3 Participants | 3 Participants | 6 Participants |
| Age, Customized 85 Years or older | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 6 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 8 Participants | 15 Participants |
| Region of Enrollment United States | 7 participants | 8 participants | 15 participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 |
| other Total, other adverse events | 6 / 7 | 8 / 8 |
| serious Total, serious adverse events | 2 / 7 | 1 / 8 |
Outcome results
Primary
Change in Choroidal Neovascularization (CNV) Over Time
Mean change from baseline in CNV area in the study eye
Time frame: Month 9
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ICON-1 Maintenance Therapy | Change in Choroidal Neovascularization (CNV) Over Time | CNV Size-Smaller | 2 participants |
| ICON-1 Maintenance Therapy | Change in Choroidal Neovascularization (CNV) Over Time | CNV Size- Larger | 0 participants |
| ICON-1 Maintenance Therapy | Change in Choroidal Neovascularization (CNV) Over Time | CNV Size-No Change | 2 participants |
| ICON-1 Maintenance Therapy | Change in Choroidal Neovascularization (CNV) Over Time | CNV Size-Cannot Grade | 1 participants |
| ICON-1 Combination Therapy | Change in Choroidal Neovascularization (CNV) Over Time | CNV Size-No Change | 2 participants |
| ICON-1 Combination Therapy | Change in Choroidal Neovascularization (CNV) Over Time | CNV Size-Smaller | 5 participants |
| ICON-1 Combination Therapy | Change in Choroidal Neovascularization (CNV) Over Time | CNV Size-Cannot Grade | 0 participants |
| ICON-1 Combination Therapy | Change in Choroidal Neovascularization (CNV) Over Time | CNV Size- Larger | 1 participants |
Secondary
Change in Best Corrected Visual Acuity (BCVA) Over Time
Mean change from baseline in BCVA letter score in the study eye
Time frame: Month 9
Population: Due to the small sample size and early termination of the study conclusions can not be accurately made from the available data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ICON-1 Maintenance Therapy | Change in Best Corrected Visual Acuity (BCVA) Over Time | 1 Letters |
| ICON-1 Combination Therapy | Change in Best Corrected Visual Acuity (BCVA) Over Time | 0 Letters |