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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This Phase I/II study will investigate the safety and tolerability of intravitreally administered 0.5mg and 1.0 or 2.0mg Ranibizumab in three monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month of drug safety follow up in subjects with exudative polypoidal choroidal vasculopathy (PCV) for a total of 24 months.
Twenty eyes will be randomized will receive 3 consecutive monthly intravitreal 1.0 or 2.0 mg/0.5mg (3:1 ratio) Ranibizumab injection with the first injection occuring at Day 0 and second and third injection occuring at month 1 and month 2 respectively. Retreatment with intravitreal Ranibizumab or other therapies will be at the investigators discretion but guidelines for recommended retreatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab 1.0 or 2.0 mg (HIGH DOSE) | Experimental | Intraocular injection of 1.0 or 2.0 mg/0.05 cc ranibizumab. Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met |
|
| Ranibizumab 0.5 mg | Active Comparator | Intraocular injection of 0.5 mg/0.05 cc ranibizumab. Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab 0.5 or 2.0 mg/0.05 cc | Drug | ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups. | Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more clinical macula (arcade to arcade), disease related vitreous hemorrhage, injection-related endophthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure - related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months | 12 months | |
| Change in Mean Central Foveal Thickness From Baseline | 12 Months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis M. Marcus, M.D. | Southeast Retina Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab 1.0 or 2.0 mg (HIGH DOSE) | Intraocular injection of 2.0 mg/0.05 cc ranibizumab or 1.0mg/0.05cc ranibizumab. Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met ranibizumab 0.5 or 2.0 mg/0.05 cc: ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up. |
| FG001 | Ranibizumab 0.5 mg | Intraocular injection of 0.5 mg/0.05 cc ranibizumab. Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met ranibizumab 0.5 or 2.0 mg/0.05 cc: ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab 1.0 or 2.0 mg (HIGH DOSE) | Intraocular injection of 2.0 mg/0.05 cc ranibizumab. Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met ranibizumab 0.5 or 2.0 mg/0.05 cc: ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up. |
| 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 | Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups. | Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more clinical macula (arcade to arcade), disease related vitreous hemorrhage, injection-related endophthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure - related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs. | Posted | Number | Adverse events | 2 years |
|
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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 | Control Group: Ranibizumab 0.5mg | standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Affected vision | Eye disorders | Systematic Assessment | Blurred or decreased vision, floaters, dark spots, flashes, light sensitivity |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dennis Marcus | Southeast Retina Center | 706-650-0061 | dmarcus@southeastretina.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2010 | Apr 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000092342 | Polypoidal Choroidal Vasculopathy |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
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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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|
| Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months |
| 12 Months |
| Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 3 Months |
| Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 6 months |
| Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 9 Months |
| Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 12 Months |
| Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12 | 12 months |
| Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 3 months |
| Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 6 months |
| Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 9 months |
| Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 12 months |
| BG001 | Ranibizumab 0.5 mg | Intraocular injection of 0.5 mg/0.05 cc ranibizumab. Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met ranibizumab 0.5 or 2.0 mg/0.05 cc: ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment |
|
|
|
| Secondary | Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months | Randomized in a 3:1 ratio - number in participant flow is 20 | Posted | Mean | Full Range | letters | 12 months |
|
|
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| Secondary | Change in Mean Central Foveal Thickness From Baseline | Randomized in a 3:1 ratio | Posted | Mean | Standard Deviation | um | 12 Months |
|
|
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| Secondary | Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months | Randomized in a 3:1 ratio | Posted | Mean | Full Range | mm^2 | 12 Months |
|
|
|
| Secondary | Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | Randomized in a 3:1 ratio - number in participant flow is 20 | Posted | Count of Participants | Participants | 3 Months |
|
|
|
| Secondary | Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | Randomized in a 3:1 ratio - number in participant flow is 20 | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | Randomized in a 3:1 ratio - number in participant flow is 20 | Posted | Count of Participants | Participants | 9 Months |
|
|
|
| Secondary | Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | Randomized in a 3:1 ratio - number in participant flow is 20 | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Secondary | Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12 | Randomized in a 3:1 ratio - number in participant flow is 20 | Posted | Mean | Standard Deviation | letters | 12 months |
|
|
|
| Secondary | Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | Randomized in a 3:1 ratio - number in participant flow is 20 | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | Randomized in a 3:1 ratio - number in participant flow is 20 | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | Randomized in a 3:1 ratio - number in participant flow is 20 | Posted | Count of Participants | Participants | 9 months |
|
|
|
| Secondary | Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | Randomized in a 3:1 ratio - number in participant flow is 20 | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 5 |
| 2 |
| 5 |
| EG001 | Ranibizumab 1.0mg or 2.0mg | high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment | 0 | 15 | 9 | 15 |
|
| Intravitreal injection side effects | Eye disorders | Systematic Assessment | Injection site or pain, subretinal hemorrhage |
|
| Increased cataract | Eye disorders | Systematic Assessment | Increased cataract from baseline measurement as determined during slit lamp ocular exam |
|
| Superior hemorrhage | Eye disorders | Systematic Assessment | Superior hemorrhage |
|
| Increased Choroidal neovascularization | Eye disorders | Systematic Assessment | As identified by FA |
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| Corneal Abrasion | Eye disorders | Systematic Assessment |
|
| Trace epiretinal membrane | Eye disorders | Systematic Assessment | identified on clinical exam and OCT |
|
| Progression of edema | Cardiac disorders | Systematic Assessment | self reported by subject |
|
| Elevated Blood pressure | Cardiac disorders | Systematic Assessment | Self reported by subject |
|
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| D008679 |
| Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| 15 letters or more |
|
| Less than 5 letters |
|
| Unevaluable |
|
| 15 or more letters |
|
| 15 letters |
|
| 15 letters |
|
| Mean Change Baseline - M9 |
|
| Mean Change Baseline - M12 |
|
| 15 letters |
|
| 15 letters |
|
| 15 letters |
|
| 15 letters |
|