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To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis® in subjects with wet age-related macular degeneration (AMD) compared with Lucentis® alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2.0 mg DE-122 | Experimental | 2.0 mg DE-122 and Lucentis ® 0.5 mg |
|
| 4.0 mg DE-122 | Experimental | 4.0 mg DE-122 and Lucentis ® 0.5 mg |
|
| Sham | Sham Comparator | Sham and Lucentis ® 0.5 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2.0 mg DE-122 Injectable Solution + Lucentis | Drug | Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24 | BCVA is the primary efficacy variable for this study, and mean change from baseline in BCVA at Week 24 is the primary efficacy endpoint. An increase in the number of letters read correctly means that vision has improved.The lower the number of letters read correctly on the eye chart, the worse the vision. | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
[Ocular]
[Non-ocular]
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Research Institute | Gilbert | Arizona | 85296 | United States | ||
| Retina-Vitreous Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham | Sham and Lucentis Lucentis: Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis. |
| FG001 | 2.0 mg DE-122 | Low Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis. |
| 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 | Jan 8, 2019 | Jun 9, 2021 |
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| 4.0 mg DE-122 Injectable Solution + Lucentis | Drug | Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis. |
|
| Lucentis | Drug | Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis. |
|
| Beverly Hills |
| California |
| 90211 |
| United States |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
| Bay Area Retina Associates | Walnut Creek | California | 94598 | United States |
| Colorado Retina Associates | Golden | Colorado | 80401 | United States |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Retina Reseach Center | Austin | Texas | 78705 | United States |
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| Valley Retina Insititute | McAllen | Texas | 78503 | United States |
| Asian Eye Institute | Makati City | Philippines |
| Peregrine Eye and Laser Institute | Makati City | Philippines |
| The Medical City | Pasig | Philippines |
| St. Luke's Medical center Quezon City | Quezon City | Philippines |
| FG002 | 4.0 mg DE-122 | High Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham | Sham and Lucentis Lucentis: Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis. |
| BG001 | 2.0 mg DE-122 | Low Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis. |
| BG002 | 4.0 mg DE-122 | High Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis. |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24 | BCVA is the primary efficacy variable for this study, and mean change from baseline in BCVA at Week 24 is the primary efficacy endpoint. An increase in the number of letters read correctly means that vision has improved.The lower the number of letters read correctly on the eye chart, the worse the vision. | Posted | Mean | Standard Deviation | letters | Week 24 |
|
|
|
From Inform consent to the end of the study at week 32.
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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 | Sham | Sham and Lucentis Lucentis: Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis. | 0 | 17 | 1 | 17 | 5 | 17 |
| EG001 | 2.0 mg DE-122 | Low Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis. | 0 | 31 | 1 | 31 | 10 | 31 |
| EG002 | 4.0 mg DE-122 | High Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis. | 1 | 28 | 4 | 28 | 10 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Subretinal fluid | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Conjunctival oedema | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Erythema of eyelid | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Vitreous hemorrhage | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R&D Quality Manager | Santen Inc | +1 415 268 9199 | clinicaltrials@santen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 11, 2019 | Jun 9, 2021 | 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 |
|---|---|
| D000069579 | Ranibizumab |
| 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 |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Philippines |
|