Age-related Macular Degeneration, Choroidal Neovascularization
Conditions
Brief summary
The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
Interventions
BIOLOGICALhI-con1
Intravitreal injection of hI-con1 0.3 mg
BIOLOGICALranibizumab
Intravitreal injection of ranibizumab 0.5 mg
OTHERSham injection
No injection is given, a needleless syringe is used to mimic an injection.
Sponsors
Iconic Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females of any race at least 50 years of age * Active primary Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) in the study eye * Best Corrected Visual Acuity (BCVA) of 70 to 24 letters (worse than 20/40 up to 20/320) in the study eye
Exclusion criteria
* Monocular patient or patient with a BCVA of 35 or fewer letters (20/200 or worse) in the better seeing eye * 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 * Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3 | Baseline and Month 3 | 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. |
| Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3 | Baseline and Month 3 | Optical 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in BCVA in the Study Eye at Month 6 | Baseline and Month 6 | 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. |
| Change From Baseline in CST in the Study Eye at Month 6 | Baseline and Month 6 | Central Retinal Subfield Thickness (CST) as measured by Optical Coherence Tomography (OCT). The change from the baseline measurement was compared to the month 6 measurement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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 | 30 |
| 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. | 28 |
| Total | 88 |
Baseline characteristics
| Characteristic | hI-con1 | hI-con1 + Ranibizumab | Ranibizumab | Total |
|---|---|---|---|---|
| Age, Continuous | 74.4 years STANDARD_DEVIATION 10.65 | 78.4 years STANDARD_DEVIATION 9.92 | 78.8 years STANDARD_DEVIATION 7.19 | 77.1 years STANDARD_DEVIATION 9.52 |
| Region of Enrollment United States | 30 participants | 30 participants | 28 participants | 88 participants |
| Sex: Female, Male Female | 19 Participants | 17 Participants | 17 Participants | 53 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 11 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 28 |
| other Total, other adverse events | 21 / 30 | 26 / 30 | 12 / 28 |
| serious Total, serious adverse events | 3 / 30 | 1 / 30 | 5 / 28 |
Outcome results
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3
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.
Time frame: Baseline and Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| hI-con1 | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3 | .3 Letters | Standard Deviation 7.76 |
| hI-con1 + Ranibizumab | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3 | 6.8 Letters | Standard Deviation 8.21 |
| Ranibizumab | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3 | 7.6 Letters | Standard Deviation 7.05 |
Primary
Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3
Optical 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.
Time frame: Baseline and Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| hI-con1 | Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3 | 53.9 Microns | Standard Deviation 17.01 |
| hI-con1 + Ranibizumab | Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3 | 66.3 Microns | Standard Deviation 10.95 |
| Ranibizumab | Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3 | 64.9 Microns | Standard Deviation 27 |
Secondary
Change From Baseline in BCVA in the Study Eye at Month 6
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.
Time frame: Baseline and Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| hI-con1 | Change From Baseline in BCVA in the Study Eye at Month 6 | -2.1 Letters | Standard Deviation 8.05 |
| hI-con1 + Ranibizumab | Change From Baseline in BCVA in the Study Eye at Month 6 | 8.4 Letters | Standard Deviation 10.14 |
| Ranibizumab | Change From Baseline in BCVA in the Study Eye at Month 6 | 8.3 Letters | Standard Deviation 9.1 |
Secondary
Change From Baseline in CST in the Study Eye at Month 6
Central Retinal Subfield Thickness (CST) as measured by Optical Coherence Tomography (OCT). The change from the baseline measurement was compared to the month 6 measurement.
Time frame: Baseline and Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| hI-con1 | Change From Baseline in CST in the Study Eye at Month 6 | -35.7 Microns | Standard Deviation 71.52 |
| hI-con1 + Ranibizumab | Change From Baseline in CST in the Study Eye at Month 6 | -83.9 Microns | Standard Deviation 71.52 |
| Ranibizumab | Change From Baseline in CST in the Study Eye at Month 6 | -91.4 Microns | Standard Deviation 137.1 |