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Business Reasons
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICON-1 maintenance therapy | Experimental | ICON-1 maintenance therapy after initial aflibercept treatment |
|
| ICON-1 combination therapy | Experimental | ICON-1 combination therapy with aflibercept treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICON-1 | Biological | ICON-1 0.6 mg by intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Choroidal Neovascularization (CNV) Over Time | Mean change from baseline in CNV area in the study eye | Month 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) Over Time | Mean change from baseline in BCVA letter score in the study eye | Month 9 |
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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 |
|---|---|---|---|---|---|---|
| Site 2 | Beverly Hills | California | 90211 | United States | ||
| Site 8 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | ICON-1 Combination Therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 19, 2018 |
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| aflibercept | Biological | aflibercept 2 mg by intravitreal injection |
|
|
| Santa Ana |
| California |
| 92705 |
| United States |
| Site 7 | Syracuse | New York | 13224 | United States |
| Site 3 | Ashland | Oregon | 97520 | United States |
| Site 6 | Philadelphia | Pennsylvania | 19107 | United States |
| Site 1 | Austin | Texas | 78705 | United States |
| Site 4 | McAllen | Texas | 78503 | United States |
| Site 5 | San Antonio | Texas | 78240 | United States |
ICON-1 combination therapy with aflibercept treatment
ICON-1: ICON-1 0.6 mg by intravitreal injection
aflibercept: aflibercept 2 mg by intravitreal injection
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 in Choroidal Neovascularization (CNV) Over Time | Mean change from baseline in CNV area in the study eye | 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. | Posted | Number | participants | Month 9 |
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| Secondary | Change in Best Corrected Visual Acuity (BCVA) Over Time | Mean change from baseline in BCVA letter score in the study eye | Due to the small sample size and early termination of the study conclusions can not be accurately made from the available data. | Posted | Mean | Full Range | Letters | Month 9 |
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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.
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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 | 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 | 0 | 7 | 2 | 7 | 6 | 7 |
| EG001 | 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 | 0 | 8 | 1 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Ischemic Attach (TIA) | Vascular disorders | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
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| Metabolic Encephalopathy | Nervous system disorders | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Macular Fibrosis | Eye disorders | Systematic Assessment |
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| Photopsia | Eye disorders | Systematic Assessment |
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| Retinal Haemorrhage | Eye disorders | Systematic Assessment |
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| Subretinal Fluid | Eye disorders | Systematic Assessment |
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| Choroidal Neovascularization | Eye disorders | Systematic Assessment |
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| Conjunctival Haemorrhage | Eye disorders | Systematic Assessment |
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| Detachment of Retinal Pigment Epithelium | Eye disorders | Systematic Assessment |
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| Dry Age Related Macular Degeneration | Eye disorders | Systematic Assessment |
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| Dry eye | Eye disorders | Systematic Assessment |
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| Eyelids Pruritus | Eye disorders | Systematic Assessment |
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| Lacrimation Increased | Eye disorders | Systematic Assessment |
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| Macular Oedema | Eye disorders | Systematic Assessment |
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| Metamorphopsia | Eye disorders | Systematic Assessment |
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| Optic Ischaemic Neuropathy | Eye disorders | Systematic Assessment |
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| Retinal Depigmentation | Eye disorders | Systematic Assessment |
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| Retinal Pigment Epithelial Tear | Eye disorders | Systematic Assessment |
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| Visual Acuity Reduced | Eye disorders | Systematic Assessment |
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| Visual lmpairement | Eye disorders | Systematic Assessment |
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| Vitreous Detachment | Eye disorders | Systematic Assessment |
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| Vitreous Haemorrhage | Eye disorders | Systematic Assessment |
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| Intraocular Pressure Increased | Eye disorders | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Eye disorders | Non-systematic Assessment |
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| Asthenia | General disorders | Non-systematic Assessment |
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| Drug Hypersensitivity | Immune system disorders | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
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| Cystitis | Infections and infestations | Non-systematic Assessment |
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| Genital Herpes | Infections and infestations | Non-systematic Assessment |
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| Wound Infection | Infections and infestations | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabriela Burian, M.D. | Iconic Therapeutics | 6504371000 | gburian@iconictherapeutics.com |
| Aug 24, 2020 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D057135 | Wet 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 |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Title | Measurements |
|---|---|
|
| 75 to <85 |
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| 85 Years or older |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| CNV Size- Larger |
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| CNV Size-Cannot Grade |
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