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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This is a 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator | 12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab |
|
| Cohort 2 | Active Comparator | 6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg |
|
| Cohort 3 | Active Comparator | 24 months of monthly, intravitreal injections of ranibizumab 1.0mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high-dose ranibizumab | Drug | 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly |
|
| Measure | Description | Time Frame |
|---|---|---|
| BCVA | Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at a starting test distance of 4 meters from Baseline to Month 12. | From Baseline to Month 12 |
| BCVA | Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from Baseline to Month 24 | Baseline to M24 |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Adverse Events (AE) | Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing) | Monthly |
| Systemic AEs | Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregg T Kokame, MD, MMM | Hawaii Pacific Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Hawaii | Honolulu | Hawaii | 96817 | United States | ||
| Retina Consultants of Hawaii |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | 24 months of monthly, intravitreal injections of ranibizumab 1.0mg ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly |
| FG001 | Cohort 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ranibizumab | Drug | 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly |
|
|
| Monthly |
| BCVA | Best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters, at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24 | at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24 |
| Macular Edema | Optical Coherence Tomography (OCT) central macular and peripapillary thickness | Baseline, Day 14, Month 1-24 |
| PCV Anatomic Changes | Decrease and/or resolution in the branching vascular network of the PCV complex as measured by mean size of the branched vascular network (BVN) on ICG and fluorescein angiography Decrease and/or resolution of the polyps of the PCV complex as measured on ICG and fluorescein angiography | Baseline, Months 6, 12, 24 |
| Fundus Clinical Findings | Decrease in subretinal hemorrhage or exudates as measured by mean size as noted on fundus photography and clinic exam | Baseline, Months 6, 12, 24 |
| ‘Aiea |
| Hawaii |
| 96701 |
| United States |
| The Retina Center at Pali Momi | ‘Aiea | Hawaii | 96701 | United States |
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
| FG002 | Cohort 3 | 12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | 24 months of monthly, intravitreal injections of ranibizumab 1.0mg ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly |
| BG001 | Cohort 2 | 6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly |
| BG002 | Cohort 3 | 12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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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| Ethnicity (NIH/OMB) | 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 | BCVA | Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at a starting test distance of 4 meters from Baseline to Month 12. | Posted | Mean | Standard Deviation | number of letters read correctly | From Baseline to Month 12 |
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| ||||||||||||||||||||||||||||||||
| Primary | BCVA | Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from Baseline to Month 24 | Posted | Mean | Standard Deviation | number of letters read correctly | Baseline to M24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Ocular Adverse Events (AE) | Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing) | Posted | Number | Ocular adverse events | Monthly |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Systemic AEs | Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs | Posted | Number | Number of Participants with Systemic AEs | Monthly |
| |||||||||||||||||||||||||||||||||||
| Secondary | BCVA | Best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters, at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24 | Posted | Mean | Standard Deviation | number of letters read correctly | at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Macular Edema | Optical Coherence Tomography (OCT) central macular and peripapillary thickness | Patient in Cohort 2 missed several visits. | Posted | Mean | Standard Deviation | microns | Baseline, Day 14, Month 1-24 |
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| Secondary | PCV Anatomic Changes | Decrease and/or resolution in the branching vascular network of the PCV complex as measured by mean size of the branched vascular network (BVN) on ICG and fluorescein angiography Decrease and/or resolution of the polyps of the PCV complex as measured on ICG and fluorescein angiography | Posted | Number | Participants with PCV Anatomic Changes | Baseline, Months 6, 12, 24 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Fundus Clinical Findings | Decrease in subretinal hemorrhage or exudates as measured by mean size as noted on fundus photography and clinic exam | Posted | Number | Participants with Fundus Findings | Baseline, Months 6, 12, 24 |
|
Adverse event data include events starting on day 0 and ending at month 24.
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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 | Cohort 1 | 24 months of monthly, intravitreal injections of ranibizumab 1.0mg ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly | 1 | 4 | 1 | 4 | ||
| EG001 | Cohort 2 | 6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg high-dose ranibizumab: 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly | 0 | 2 | 1 | 3 | ||
| EG002 | Cohort 3 | 12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab high-dose ranibizumab: 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly | 0 | 15 | 7 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Pneumonia requiring hospitalization. Adverse event recorded by follow up call and visits. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flu-like symptoms | General disorders | Non-systematic Assessment | Patient explained during visit. |
| |
| Rash | General disorders | Non-systematic Assessment | Patient explained during visit. |
| |
| Ear Infection | Infections and infestations | Systematic Assessment | Patient explained during visit. |
| |
| Body ache, fever, hives | General disorders | Non-systematic Assessment | Patient explained during visit |
| |
| Bone Marrow Tap | Investigations | Systematic Assessment | Patient explained during visit. |
| |
| Peripheral Neuropathy | Nervous system disorders | Systematic Assessment | Patient explained during visit. |
| |
| Stent Placement for artery blockage | Surgical and medical procedures | Systematic Assessment | Patient explained during visit. |
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| Sinusitis | Infections and infestations | Systematic Assessment | Patient explained during visit. |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Patient explained during visit. |
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Small sample size for each arms group.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregg Kokame, MD | Retina Consultants of Hawaii, Inc. | (808) 487-8928 | retinahi@aol.com |
| ID | Term |
|---|---|
| D000092342 | Polypoidal Choroidal Vasculopathy |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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