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The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose DE-122 | Experimental | Single intravitreal injection of DE-122 Low Dose Injectable Solution |
|
| Medium-Low Dose DE-122 | Experimental | Single intravitreal injection of DE-122 Medium-Low Dose Injectable Solution |
|
| Medium-High Dose DE-122 | Experimental | Single intravitreal injection of DE-122 Medium-High Dose Injectable Solution |
|
| High Dose DE-122 | Experimental | Single intravitreal injection of DE-122 High Dose Injectable Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5 mg of DE-122 | Drug | DE-122 Injectable Solution |
| |
| 1.0 mg of DE-122 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90. | BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of [0, 97] in ETDRS letters. An increase in BCVA indicates an improvement in the best corrected vision. | Baseline (Day1) and Day 90. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Central Subfield Thickness (CST) at Day 90. | Bioactivity measures include CST (μm) measured by SD-OCT. Bioactivity will be considered evident if a considerable decrease in CST is observed. | Baseline (Day1) and Day 90. |
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Inclusion Criteria:
Exclusion Criteria:
Ocular
Non-Ocular
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mountain View | California | 94040 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.5 mg of DE-122 | Single intravitreal injection of Low Dose DE-122 Injectable Solution |
| FG001 | 1.0 mg of DE-122 | Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution |
| 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 | Yes | No | No | Study Protocol | Jun 30, 2016 | Jan 9, 2020 |
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| Drug |
DE-122 Injectable Solution |
|
| 2.0 mg of DE-122 | Drug | DE-122 Injectable Solution |
|
| 4.0 mg of DE-122 | Drug | DE-122 Injectable Solution |
|
| Walnut Creek |
| California |
| 94598 |
| United States |
| Jackson | Michigan | 49202 | United States |
| Austin | Texas | 78705 | United States |
| McAllen | Texas | 78503 | United States |
| FG002 | 2.0 mg of DE-122 | Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution |
| FG003 | 4.0 mg of DE-122 | Single intravitreal injection of High Dose DE-122 Injectable Solution |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.5 mg of DE-122 | Single intravitreal injection of Low Dose DE-122 Injectable Solution |
| BG001 | 1.0 mg of DE-122 | Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution |
| BG002 | 2.0 mg of DE-122 | Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution |
| BG003 | 4.0 mg of DE-122 | Single intravitreal injection of High Dose DE-122 Injectable Solution |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90. | BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of [0, 97] in ETDRS letters. An increase in BCVA indicates an improvement in the best corrected vision. | Posted | Mean | Standard Deviation | ETDRS letters | Baseline (Day1) and Day 90. |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Central Subfield Thickness (CST) at Day 90. | Bioactivity measures include CST (μm) measured by SD-OCT. Bioactivity will be considered evident if a considerable decrease in CST is observed. | Posted | Mean | Standard Deviation | microns | Baseline (Day1) and Day 90. |
|
|
From Visit 1 (Day 1) to Study Exit (Day 90)]
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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 | 0.5 mg of DE-122 | Single intravitreal injection of Low Dose DE-122 | 0 | 3 | 0 | 3 | 0 | 3 |
| EG001 | 1.0 mg of DE-122 | Single intravitreal injection of Medium-Low Dose DE-122 | 0 | 3 | 0 | 3 | 2 | 3 |
| EG002 | 2.0 mg of DE-122 | Single intravitreal injection of Medium-High Dose DE-122 | 0 | 3 | 0 | 3 | 2 | 3 |
| EG003 | 4.0 mg of DE-122 | Single intravitreal injection of High Dose DE-122 | 0 | 3 | 0 | 3 | 3 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | Systematic Assessment |
| ||
| Deposit eye | Eye disorders | Systematic Assessment |
| ||
| Foreign body sensation in eyes | Eye disorders | Systematic Assessment |
| ||
| Hyphaema | Eye disorders | Systematic Assessment |
| ||
| Lacrimation increased | Eye disorders | Systematic Assessment |
| ||
| Photophobia | Eye disorders | Systematic Assessment |
| ||
| Retinal haemorrhage | Eye disorders | Systematic Assessment |
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| Vision blurred | Eye disorders | Systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Spinal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R&D Quality Manager | Santen Inc | +1 415 268 9199 | evelyn.chikere@santen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 9, 2017 | Jan 9, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C579557 | carotuximab |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|
| 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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| Participants |
|
|