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The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy.
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy in either a "Simultaneous" Regimen (Fovista® administered with anti-VEGF same day) or "Pre-Treatment" Regimen (monotherapy Fovista® Day 0 followed by Fovista® administered in combination with anti-VEGF Day 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fovista® plus anti-VEGF Simultaneous | Experimental | Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration. |
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| Fovista® plus anti-VEGF Pre-Treatment | Experimental | Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fovista® (anti-PDGF BB) plus anti-VEGF | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects) | Number of subjects on either arm with non-serious adverse events (reported by >5% of subjects) | 2 years |
| Number of Subjects With Serious Adverse Events | Number of subjects with serious adverse events in each arm | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85014 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen | Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration. |
| FG001 | Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Beverly Hills |
| California |
| 90211 |
| United States |
| Sacramento | California | 95819 | United States |
| Sacramento | California | 95841 | United States |
| Santa Ana | California | 92705 | United States |
| Augusta | Georgia | 30909 | United States |
| Oak Forest | Illinois | 60452 | United States |
| Boston | Massachusetts | 02114 | United States |
| Jackson | Michigan | 49202 | United States |
| Minneapolis | Minnesota | 55435 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Ladson | South Carolina | 29456 | United States |
| Abilene | Texas | 79606 | United States |
Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous | Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration |
| BG001 | Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen | Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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 | Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects) | Number of subjects on either arm with non-serious adverse events (reported by >5% of subjects) | Posted | Count of Participants | Participants | 2 years |
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| Primary | Number of Subjects With Serious Adverse Events | Number of subjects with serious adverse events in each arm | Posted | Count of Participants | Participants | 2 years |
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Up to a maximum exposure of 24 months
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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 | Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen | Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration. | 2 | 63 | 19 | 63 | 51 | 63 |
| EG001 | Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen | Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration. | 2 | 38 | 8 | 38 | 34 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Surgical failure | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Biloma | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Appendiceal abscess | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
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| Endophthalmitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Facial bone fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
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| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
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| Perirenal haematoma | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
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| Blood pressure decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
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| Intervertebral disc displacement | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
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| Metastasis to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
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| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Ischemic stroke | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Shock haemorrhagic | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Conjuctival haemorrhage | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Eye Pain | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Intraocular pressure increased | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Neovascular age-related macular degeneration | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Vitreous detachment | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
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Institution agrees not to individually publish the results of the Study without Ophthotech's prior written consent. Institution may participate in a joint, multi-center publication of the Study results with other investigators and/or institutions only, upon the prior written consent of Ophthotech.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith Westby | Ophthotech Corp. | 732-824-7474 | keith.westby@ophthotech.com |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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