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The objectives of this study are to evaluate the safety and efficacy of E10030 intravitreous injection when administered in combination with Lucentis® against a control of Lucentis® alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).
Subjects will be randomized in a 1:1:1 ratio to the following dose groups:
Subjects will be treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.
Primary Efficacy Endpoint:
The primary efficacy endpoint is mean change in visual acuity from baseline at the Week 24 visit
Safety Endpoints:
Safety endpoints include adverse events, vital signs, ophthalmic variables [visual acuity, intraocular pressure (IOP), ophthalmic examination, color fundus photography, fluorescein angiograms (FA), optical coherence tomography (OCT)], and laboratory variables.
Approximately 444 subjects will be randomized into one of the three treatment cohorts (approximately 148 patients per dose group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lucentis | Active Comparator |
| |
| E10030 low dose plus Lucentis | Experimental |
| |
| E10030 high dose plus Lucentis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E10030 plus Lucentis | Drug | once a month intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Visual Acuity From Baseline at the Week 24 Visit | The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit | The proportion of subjects gaining 15 or more ETDRS letters from baseline at the Week 24 visit | 24 weeks |
| Proportion of Patients With at Least 1 Adverse Event |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following underlying diseases including:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palmetto Retinal Center | West Columbia | South Carolina | 29169 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30957581 | Derived | Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. |
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This study enrolled 449 patients at approximately 69 centers in North America, South America, Europe and Israel.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lucentis | Sham/Lucentis 0.5 mg |
| FG001 | E10030 0.3 mg/Lucentis 0.5 mg | E10030 0.3 mg/Lucentis 0.5 mg |
| FG002 | E10030 1.5 mg/Lucentis 0.5 mg | E10030 1.5 mg/Lucentis 0.5 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lucentis | Sham/Lucentis 0.5 mg |
| BG001 | E10030 Low Dose Plus Lucentis | E10030 0.3 mg/Lucentis 0.5 mg |
| 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 Visual Acuity From Baseline at the Week 24 Visit | The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit | Intent to Treat Population (last observation carried forward) | Posted | Mean | Standard Error | ETDRS Letters | 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 | Lucentis | Sham/Lucentis 0.5 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic Valve Stenosis | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hemorrhage | Eye disorders | MedDRA (11.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Nau | Ophthotech | 646-573-7045 | jeff.nau@ophthotech.com |
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| 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 |
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| Lucentis | Drug | 10 mg/mL intravitreal injection monthly |
|
| 24 weeks |
| BG002 |
| E10030 High Dose Plus Lucentis |
E10030 1.5 mg/Lucentis 0.5 mg |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
E10030 1.5 mg/Lucentis 0.5 mg |
|
|
| Secondary | The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit | The proportion of subjects gaining 15 or more ETDRS letters from baseline at the Week 24 visit | Intent to Treat Population (last observation carried forward) | Posted | Number | % subjects (i.e gaining >/=15 letters) | 24 weeks |
|
|
|
| Secondary | Proportion of Patients With at Least 1 Adverse Event | Safety Analysis Population | Posted | Number | % of patients with adverse events | 24 weeks |
|
|
|
| 12 |
| 148 |
| 63 |
| 148 |
| EG001 | E10030 Low Dose Plus Lucentis | E10030 0.3 mg/Lucentis 0.5 mg | 14 | 149 | 63 | 149 |
| EG002 | E10030 High Dose Plus Lucentis | E10030 1.5 mg/Lucentis 0.5 mg | 10 | 152 | 69 | 152 |
| Atrial Fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | Systematic Assessment |
|
| Corneal Erosion | Eye disorders | Systematic Assessment |
|
| Uveitis | Eye disorders | Systematic Assessment |
|
| Visual Acuity Reduced | Eye disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Duodenal Ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Inguinal Hernia, Obstructive | Gastrointestinal disorders | Systematic Assessment |
|
| Rectal Hemmorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Urinary Tract infection | Infections and infestations | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Spondylitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lung squamous cell carcinoma, unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Metastatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Benign salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Brain Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Cerebral Infarction | Nervous system disorders | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | Systematic Assessment |
|
| Loss of Consciousness | Nervous system disorders | Systematic Assessment |
|
| Vascular Encephalopathy | Nervous system disorders | Systematic Assessment |
|
| Mental status change | Psychiatric disorders | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Arterial Disorder | Vascular disorders | Systematic Assessment |
|
| Haematoma | Vascular disorders | Systematic Assessment |
|
| Punctate Keratitis | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Eye Pain | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Conjunctival hyperemia | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Subretinal fibrosis | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
No individual site or investigator may publish or present any results from the trial until a joint, multi center publication of the trial results is made by Sponsor in conjunction with various participating investigators and appropriate sites contributing data and comments. Subsequently, individual investigators may request to publish or present results from the trial; however, approval will be at the sole discretion of the Sponsor.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |