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To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.
60 subjects randomized 1:1:1 and treated with IVT Fovista® 1.5 mg/eye in combination with anti-VEGF therapy as follows:
Subjects will be stratified by lesion size (≤2 DA vs. >2 DA).
Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months.
When administered, IVT Fovista® will be given first, followed by IVT anti-VEGF (same day).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fovista® plus bevacizumab | Experimental | Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection |
|
| Fovista® plus ranibizumab | Experimental | Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection |
|
| Fovista® plus aflibercept | Experimental | Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fovista® | Drug |
| ||
| bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Total Numer of Systemic Adverse Events | Number of Patients with Systemic Adverse Events | 2 years |
| Total Number of Other Adverse Events (>5%) | Number of Patients with Other Adverse Events | 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 | |||
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fovista® Plus Bevacizumab | Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection Fovista® bevacizumab |
| FG001 | Fovista® Plus Ranibizumab | Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection Fovista® ranibizumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
|
| ranibizumab | Drug |
|
|
| aflibercept | Drug |
|
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| Beverly Hills |
| California |
| 90211 |
| United States |
| Sacramento | California | 95819 | United States |
| Santa Ana | California | 92705 | United States |
| New London | Connecticut | 06320 | United States |
| Fort Lauderdale | Florida | 33308 | United States |
| Fort Myers | Florida | 33912 | United States |
| Augusta | Georgia | 30909 | United States |
| Oak Forest | Illinois | 60452 | United States |
| Boston | Massachusetts | 02114 | United States |
| Worcester | Massachusetts | 01605 | United States |
| Southfield | Michigan | 48034 | United States |
| Minneapolis | Minnesota | 55435 | United States |
| Reno | Nevada | 89502 | United States |
| Rochester | New York | 14620 | United States |
| Cleveland | Ohio | 44130 | United States |
| Huntingdon Valley | Pennsylvania | 19006 | United States |
| Ladson | South Carolina | 29456 | United States |
| Abilene | Texas | 85014 | United States |
| Amarillo | Texas | 79106 | United States |
| San Antonio | Texas | 78240 | United States |
| The Woodlands | Texas | 77384 | United States |
| Silverdale | Washington | 98383 | United States |
| Morgantown | West Virginia | 26506 | United States |
| FG002 | Fovista® Plus Aflibercept | Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection Fovista® aflibercept |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fovista® Plus Bevacizumab | Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection Fovista® bevacizumab |
| BG001 | Fovista® Plus Ranibizumab | Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection Fovista® ranibizumab |
| BG002 | Fovista® Plus Aflibercept | Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection Fovista® aflibercept |
| 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, 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 |
| ||||||||||||||||
| 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 | Total Numer of Systemic Adverse Events | Number of Patients with Systemic Adverse Events | Posted | Count of Participants | Participants | 2 years |
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| Primary | Total Number of Other Adverse Events (>5%) | Number of Patients with Other Adverse Events | 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® Plus Bevacizumab | Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection Fovista® bevacizumab | 0 | 21 | 3 | 21 | 15 | 21 |
| EG001 | Fovista® Plus Ranibizumab | Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection Fovista® ranibizumab | 0 | 21 | 3 | 21 | 16 | 21 |
| EG002 | Fovista® Plus Aflibercept | Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection Fovista® aflibercept | 0 | 21 | 5 | 21 | 16 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cervical spine stenosis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Lung carcinoma cell type unspecified reccurent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neovascular age-related macular degeneration | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Conjuctival haemorrhage | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Seasonal allergy | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Ocular Discomfort | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
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 | |
|---|---|---|---|---|
| Denise Teuber | Ophthotech Corp. | 646-753-8461 | denise.teuber@ophthotech.com |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069579 | Ranibizumab |
| C533178 | aflibercept |
| 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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| Between 18 and 65 years |
|
| >=65 years |
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| 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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