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Phase 1: The purpose of this study is to evaluate the safety and tolerability of single ascending doses of hI-con1â„¢ for subjects with Age-Related Macular Degeneration.
Phase 2: The purpose of this study is to evaluate the safety of 3 injections of hI-con1â„¢ at 2 different dose levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hI-con1™ 60µl | Experimental | Phase 1- This is a dose escalation study (60µl, 150µl, or 300 µl) given at baseline and then the subject is followed up to week 24. |
|
| hI-con1™ 150µl | Experimental | Phase 1- This is a dose escalation study (60µl, 150µl, or 300 µl) given at baseline and then the subject is followed up to week 24. |
|
| hI-con1™ 300µl | Experimental | Phase 1- This is a dose escalation study (60µl, 150µl, or 300 µl) given at baseline and then the subject is followed up to week 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hI-con1™ 60µl | Drug | Phase 1: 60µl, 150µl, or 300µl per injection (in the eye) on Day 1 only |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Central Retinal Subfield Thickness as Measured by Optical Coherence Tomography (OCT) at Week 24 From Baseline | The Mean Change in Central Retinal Subfield Thickness as Measured by OCT is part of the evaluation on the safety and tolerability of single ascending doses of hI-con1 and to assist in determining the Maximum Tolerated Dose (MTD) that can be administered by intravitreal injection. | 24 Weeks |
| Mean Change in Best Corrected Visual Acuity (BCVA) at Week 24 From Baseline | The Mean Change in Best Corrected Visual Acuity (BCVA) is part of the evaluation on the safety and tolerability of single ascending doses of hI-con1 and to assist in determining the Maximum Tolerated Dose (MTD) that can be administered by intravitreal injection. BCVA is measured using the Early Diabetic Retinopathy Study (EDTRS) chart. More letters read result in a higher score. | 24 Weeks |
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Ocular Inclusion Criteria:
General Inclusion Criteria
Ocular Exclusion Criteria:
General Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Eye Center, P.C. | Missoula | Montana | 59801 | United States | ||
| Retina & Vitreous Center of Southern Oregon, P.C. |
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| ID | Title | Description |
|---|---|---|
| FG000 | hI-con1™ 60µg | Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24. hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only |
| FG001 | hI-con1™ 150µg | Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24. hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only |
| FG002 | hI-con1™ 300µg | Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24. hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | hI-con1™ 60µg | This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24. |
| BG001 | hI-con1™ 150µg | This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Mean Change in Central Retinal Subfield Thickness as Measured by Optical Coherence Tomography (OCT) at Week 24 From Baseline | The Mean Change in Central Retinal Subfield Thickness as Measured by OCT is part of the evaluation on the safety and tolerability of single ascending doses of hI-con1 and to assist in determining the Maximum Tolerated Dose (MTD) that can be administered by intravitreal injection. | Posted | Mean | Standard Deviation | Microns | 24 Weeks |
|
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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™ 60µg | Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24. hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Premature Atrial Contractions | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior Chamber Cell | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabriela Burian, M.D. | Iconic Therapeutics | 6504371000 | gburian@iconictherapeutics.com |
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| ID | Term |
|---|---|
| C562041 | hI-con1 |
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| hI-con1™ 150µl | Drug | Phase 1: 60µl, 150µl, or 300µl per injection (in the eye) on Day 1 only |
|
| hI-con1™ 300µl | Drug | Phase 1: 60µl, 150µl, or 300µl per injection (in the eye) on Day 1 only |
|
| Ashland |
| Oregon |
| 97520 |
| United States |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | United States |
| Retina Research Center | Austin | Texas | 78705 | United States |
| Valley Retina Institute, PA | McAllen | Texas | 78503 | United States |
| BG002 | hI-con1™ 300µg | This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only
| OG002 | hI-con1™ 300µg | Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24. hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only |
|
|
| Primary | Mean Change in Best Corrected Visual Acuity (BCVA) at Week 24 From Baseline | The Mean Change in Best Corrected Visual Acuity (BCVA) is part of the evaluation on the safety and tolerability of single ascending doses of hI-con1 and to assist in determining the Maximum Tolerated Dose (MTD) that can be administered by intravitreal injection. BCVA is measured using the Early Diabetic Retinopathy Study (EDTRS) chart. More letters read result in a higher score. | Posted | Mean | Standard Deviation | Letters | 24 Weeks |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | hI-con1™ 150µg | Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24. hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only | 0 | 6 | 0 | 6 | 6 | 6 |
| EG002 | hI-con1™ 300µg | Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24. hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only | 0 | 6 | 1 | 6 | 6 | 6 |
| Blepharitis | Eye disorders | Systematic Assessment |
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| Conjunctival Haemorrhage | Eye disorders | Systematic Assessment |
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| ConjunctivalHyperaemia | Eye disorders | Systematic Assessment |
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| Conjunctival Oedema | Eye disorders | Systematic Assessment |
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| Corneal Epithelium Defect | Eye disorders | Systematic Assessment |
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| Detachment of Retinal Pigment Epithelium | Eye disorders | Systematic Assessment |
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| Eye Irritation | Eye disorders | Systematic Assessment |
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| Eye Pain | Eye disorders | Systematic Assessment |
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| Eye Pruritus | Eye disorders | Systematic Assessment |
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| Macular Degeneration | Eye disorders | Systematic Assessment |
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| Retinal Dystrophy | Eye disorders | Systematic Assessment |
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| Retinal Exudates | Eye disorders | Systematic Assessment |
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| Retinal Haemorrhage | Eye disorders | Systematic Assessment |
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| Retinal Pigment Epithelial Tear | Eye disorders | Systematic Assessment |
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| Subretinal Fibrosis | Eye disorders | Systematic Assessment |
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| Vision Blurred | Eye disorders | Systematic Assessment |
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| Visual Acuity Reduced | Eye disorders | Systematic Assessment |
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| Vitreous Floaters | Eye disorders | Systematic Assessment |
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| Vitritis | Eye disorders | Systematic Assessment |
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