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The objective of this extension study is to evaluate the long-term safety of treatment with DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the SAKURA development program.
This is a multicenter, open-label, extension study of intravitreal injections of the 440 μg dose of DE-109 in subjects with non-infectious uveitis of the posterior segment who received any dose of DE-109 and exited the SAKURA program under Santen Protocol 32-007, Amendment 05.
Subjects who were randomized and received at least two injections of DE-109 during the first five months of the SAKURA program and obtained clinical benefit from the study medication, as determined by the Investigator, may be considered for entry in this 12-month extension study. The minimum time lag from last injection in the SAKURA program to entry into the current protocol is 60 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DE-109 Sirolimus | Experimental | DE-109 440 μg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-109 440 μg | Drug | Medium Dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye | Best Corrected Visual Acuity (BCVA) measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters. An increase in BCVA indicates improvement in the best-corrected vision. A BCVA score of 85 ETDRS letters is equivalent to 20/20 vision, which is considered normal vision. | Day 1 (Baseline) and Month 12 or early termination visit |
| Mean Change From Baseline in Intraocular Pressure at Month 12 in the Study Eye | Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg) with one decimal point. | Day 1 (Baseline) and Month 12 or early termination visit |
| Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye. | Ophthalmoscopy findings were reported as normal or abnormal. | Day 1 (Baseline) and Month 12 or early termination visit |
| Changes From Baseline in Vitreous Haze (VH) Scores at Month 12 | Vitreous Haze (VH) scores were measured using the modified Standardized Uveitis Nomenclature Photographic Scale (SUN) : 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)
| Day 1 (Baseline) and Month 12 or early termination visit |
| Number of Subjects Who Receive Rescue Therapy. | Rescue therapy was defined as any treatment that would have a therapeutic effect on the uveitis in the posterior segment (e.g., systemic treatment with an immunosuppressant agent, or a corticosteroid injection in the study eye) other than intravitreal DE-109 determined by the Investigator. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lanita Scott, MD | Santen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | DE-109 440 μg | Medium dose of DE-109 |
| 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, 2014 | Oct 18, 2019 |
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| By Month12 |
| Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye. | Ophthalmoscopy findings were reported as normal or abnormal. | Day 1 (Baseline) and Month 12 or early termination visit |
| Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye. | Ophthalmoscopy findings were reported as normal or abnormal. | Day 1 (Baseline) and Month 12 or early termination visit |
| Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye. | Ophthalmoscopy findings were reported as normal or abnormal. | Day 1 (Baseline) and Month 12 or early termination visit |
| Sacramento |
| California |
| United States |
| Golden | Colorado | United States |
| Tampa | Florida | United States |
| Oak Park | Illinois | 60304 | United States |
| Jackson | Michigan | United States |
| St Louis | Missouri | United States |
| New Brunswick | New Jersey | United States |
| Palisades Park | New Jersey | United States |
| New York | New York | United States |
| Orchard Park | New York | United States |
| Austin | Texas | United States |
| Salt Lake City | Utah | United States |
| Graz | Austria |
| Paris | France |
| Hyderabad | Andhra Pradesh | India |
| Aurobindo Marg | New Dehli | India |
| Daryāganj | New Dehli | India |
| Bhubaneswar | Odisha | India |
| Chennai | Tamil Nadu | India |
| Madurai | Tamil Nadu | India |
| Noida | Uttar Pradesh | India |
| Milan | Italy |
| Ankara | Turkey (Türkiye) |
| Izmir | Turkey (Türkiye) |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DE-109 440 μg | Medium dose of DE-109 |
| 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 |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Geographic Region | 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 Month 12 in the Study Eye | Best Corrected Visual Acuity (BCVA) measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters. An increase in BCVA indicates improvement in the best-corrected vision. A BCVA score of 85 ETDRS letters is equivalent to 20/20 vision, which is considered normal vision. | Posted | Mean | Standard Deviation | ETDRS Letters | Day 1 (Baseline) and Month 12 or early termination visit |
|
|
| ||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in Intraocular Pressure at Month 12 in the Study Eye | Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg) with one decimal point. | Posted | Mean | Standard Deviation | mmHg | Day 1 (Baseline) and Month 12 or early termination visit |
|
| |||||||||||||||||||||||||||
| Primary | Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye. | Ophthalmoscopy findings were reported as normal or abnormal. | Posted | Number | Subjects | Day 1 (Baseline) and Month 12 or early termination visit |
|
|
| |||||||||||||||||||||||||||
| Primary | Changes From Baseline in Vitreous Haze (VH) Scores at Month 12 | Vitreous Haze (VH) scores were measured using the modified Standardized Uveitis Nomenclature Photographic Scale (SUN) : 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)
| Posted | Mean | Standard Deviation | score on a scale | Day 1 (Baseline) and Month 12 or early termination visit |
|
| |||||||||||||||||||||||||||
| Primary | Number of Subjects Who Receive Rescue Therapy. | Rescue therapy was defined as any treatment that would have a therapeutic effect on the uveitis in the posterior segment (e.g., systemic treatment with an immunosuppressant agent, or a corticosteroid injection in the study eye) other than intravitreal DE-109 determined by the Investigator. | Posted | Count of Participants | Participants | By Month12 |
|
| ||||||||||||||||||||||||||||
| Primary | Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye. | Ophthalmoscopy findings were reported as normal or abnormal. | Posted | Number | Subjects | Day 1 (Baseline) and Month 12 or early termination visit |
|
|
| |||||||||||||||||||||||||||
| Primary | Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye. | Ophthalmoscopy findings were reported as normal or abnormal. | Posted | Number | Subjects | Day 1 (Baseline) and Month 12 or early termination visit |
|
|
| |||||||||||||||||||||||||||
| Primary | Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye. | Ophthalmoscopy findings were reported as normal or abnormal. | Posted | Number | Subjects | Day 1 (Baseline) and Month 12 or early termination visit |
|
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An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
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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 | DE-109 440 μg | Medium dose of DE-109 DE-109: Medium Dose of DE-109 | 0 | 60 | 8 | 60 | 35 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Vitreous Hemorrhage | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Intraocular Pressure Increased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Trigeminal Neuralgia | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cellulitis Gangrenous | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Procedural Complication | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Lung Adenocarcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Non-systematic Assessment |
| |
| Arterial Occlusive Disease | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uveitis | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cystoid Macular Oedema | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Intermediate Uvei | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Macular Fibrosis | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Intraocular Pressure Increased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Intraocular Pressure Decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (16.0) | Non-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 | Nov 15, 2017 | Oct 18, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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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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| Not reported |
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| Europe, the Middle East and Africa |
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| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
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| Normal to Normal |
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| Normal to Abnormal |
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| Abnormal to Normal |
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| Abnormal to Abnormal |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Normal to Normal |
| |||||
| Normal to Abnormal |
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| Abnormal to Normal |
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| Abnormal to Abnormal |
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| Normal to Normal |
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| Normal to Abnormal |
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| Abnormal to Normal |
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| Abnormal to Abnormal |
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| Normal to Normal |
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| Normal to Abnormal |
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| Abnormal to Normal |
| |||||
| Abnormal to Abnormal |
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