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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hI-con1 | Experimental | 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 + ranibizumab | Experimental | 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. |
|
| ranibizumab | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hI-con1 | Biological | Intravitreal injection of hI-con1 0.3 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Month 3 |
| 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. | Baseline and Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriela Burian, MD | Iconic Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85020 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ranibizumab | Biological | Intravitreal injection of ranibizumab 0.5 mg |
|
|
| Sham injection | Other | 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 |
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. |
| Baseline and Month 6 |
| Phoenix |
| Arizona |
| 85021 |
| United States |
| Arcadia | California | 91007 | United States |
| Beverly Hills | California | 90211 | United States |
| Campbell | California | 95008 | United States |
| Glendale | California | 91203 | United States |
| Laguna Hills | California | 92653 | United States |
| Mountain View | California | 94040 | United States |
| Palm Desert | California | 92260 | United States |
| Palo Alto | California | 94303 | United States |
| San Francisco | California | 94109 | United States |
| Santa Ana | California | 92705 | United States |
| Golden | Colorado | 80401 | United States |
| Boynton Beach | Florida | 33426 | United States |
| Fort Myers | Florida | 33907 | United States |
| Panama City | Florida | 32405 | United States |
| Sarasota | Florida | 34233 | United States |
| Stuart | Florida | 34994 | United States |
| Winter Haven | Florida | 33907 | United States |
| Augusta | Georgia | 30909 | United States |
| Paducah | Kentucky | 42001 | United States |
| Baltimore | Maryland | 21209 | United States |
| Boston | Massachusetts | 02111 | United States |
| Detroit | Michigan | 48072 | United States |
| Jackson | Michigan | 49202 | United States |
| Royal Oak | Michigan | 48073 | United States |
| West Bloomfield | Michigan | 48322 | United States |
| Minneapolis | Minnesota | 55435 | United States |
| Las Vegas | Nevada | 89144 | United States |
| Bloomfield | New Jersey | 07003 | United States |
| Brooklyn | New York | 11223 | United States |
| Hauppauge | New York | 11788 | United States |
| Syracuse | New York | 13224 | United States |
| Ashland | Oregon | 97520 | United States |
| Portland | Oregon | 97210 | United States |
| Huntingdon Valley | Pennsylvania | 19006 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| West Columbia | South Carolina | 29169 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Abilene | Texas | 79606 | United States |
| Austin | Texas | 78705 | United States |
| Houston | Texas | 77030 | United States |
| McAllen | Texas | 78503 | United States |
| San Antonio | Texas | 78240 | United States |
| The Woodlands | Texas | 77384 | United States |
| Salt Lake City | Utah | 84107 | United States |
| Silverdale | Washington | 98383 | United States |
| Madison | Wisconsin | 53705 | United States |
| FG001 |
| 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 |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Letters | Baseline and Month 3 |
|
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| ||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | Microns | Baseline and Month 3 |
| ||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | Letters | Baseline and Month 6 |
| ||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | Microns | Baseline and Month 6 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 30 | 3 | 30 | 21 | 30 |
| EG001 | 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 | 0 | 30 | 1 | 30 | 26 | 30 |
| EG002 | 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. | 0 | 28 | 5 | 28 | 12 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Pleural Effusion | Infections and infestations | Non-systematic Assessment |
| ||
| Subcutaneous abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Vertigo Positional | General disorders | Non-systematic Assessment |
| ||
| Cardiac Failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Prostate Cancer | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Haemorrhge | Eye disorders | Systematic Assessment |
| ||
| Vitreous Floaters | Eye disorders | Systematic Assessment |
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| Eye Pain | Eye disorders | Systematic Assessment |
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| Retinal Haemorrhage | Eye disorders | Systematic Assessment |
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| Eye Irritation | Eye disorders | Systematic Assessment |
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| Vision Blurred | Eye disorders | Systematic Assessment |
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| Vitreous Detachment | Eye disorders | Systematic Assessment |
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| Blepharitis | Eye disorders | Systematic Assessment |
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| Conjunctival Oedema | Eye disorders | Systematic Assessment |
| ||
| Punctate Keratitis | Eye disorders | Systematic Assessment |
| ||
| Increased Intraocular Pressure | Eye disorders | Systematic Assessment |
| ||
| Abnormal Visual Acuity Test | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabriela Burian, M.D. | Iconic Therapeutics | 6504371000 | gburian@iconictherapeutics.com |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
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| ID | Term |
|---|---|
| C562041 | hI-con1 |
| D000069579 | Ranibizumab |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Male |
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