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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This Phase I/II safety study is designed to investigate the safety and efficacy of ranibizumab (Lucentis) in the treatment of polypoidal choroidal vasculopathy (PCV), a potentially blinding eye disease that involves the growth of tiny, abnormal blood vessels under the retina. These abnormal blood vessels can bleed or leak fluid, causing disruption of normal retinal function and vision loss. Ranibizumab is a drug that is FDA-approved for the treatment of wet age-related macular degeneration (AMD) and is injected directly into the eye. Given the efficacy of ranibizumab in the treatment of wet AMD, and the postulated similarity between the disease mechanisms involved in both wet AMD and PCV, we believe ranibizumab will have a beneficial effect on visual function in patients with PCV.
Please see above description. Phase I/II safety study; prospective, open-label, single-center, non-randomized, uncontrolled, consecutive interventional case series. Enrolled patients are >35 years old and display exudative, active polypoidal choroidal vasculopathy (PCV) in 1 eye. PCV is defined as choroidal neovascularization that displays occult characteristics on fluorescein angiography and polypoidal interconnecting vascular channels with saccular dilatations on indocyanine green angiography and/or fluorescein angiography. Eyes receive 3 consecutive, monthly intravitreal ranibizumab injections (0.5 mg or 0.3 mg/0.05 cc) followed by monthly evaluations with the option of additional intravitreal ranibizumab or alternative treatments at the discretion of the investigator. Baseline and follow-up evaluations include medical history, blood pressure, physical examination, early treatment diabetic rentinopathy study (ETDRS) best-corrected visual acuity (BCVA), intraocular pressure measurement, complete ophthalmologic examination, fundus photography, fluorescein/ indocyanine green (ICG) angiography, and optical coherence tomography (OCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab 0.5 mg/ 0.05 cc | Experimental | Intraocular injection of 0.5 mg/ 0.05 cc ranibizumab |
|
| Ranibizumab 0.3 mg/ 0.05 cc | Experimental | Intraocular injection of 0.3 mg/ 0.05 cc ranibizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab 0.5 or 0.3 mg/0.05 cc | Drug | ranibizumab 0.5 or 0.3 mg/0.05 cc administered intraocularly on a monthly basis for 3 months, followed by monthly examination with the option of further ranibizumab treatment or other therapies at the discretion of the treating physician |
| Measure | Description | Time Frame |
|---|---|---|
| Commonly Reported and Notable Adverse Events | Incidence and severity of ocular adverse events, as identified by indirect and direct examination. Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more of clinical macula (arcade to arcade), disease-related vitreous hemorrhage, injection-related endopthalmitis, 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 |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22990319 | Derived | Marcus DM, Singh H, Lott MN, Singh J, Marcus MD. Intravitreal ranibizumab for polypoidal choroidal vasculopathy in non-Asian patients. Retina. 2013 Jan;33(1):35-47. doi: 10.1097/IAE.0b013e3182618be0. |
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Twenty subjects from one site in the United States will be enrolled. Subjects with active, exudative-PCV who have provided informed consent will be eligible. Date of first subject enrolled: May 19, 2006. Date of last subject enrolled: October 8, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intraocular Injection 0.5 mg Ranibizumab | 10 patients will receive intraocular injection 0.5 mg ranibizumab |
| FG001 | Intraocular Injection 0.3 mg Ranibizumab | 10 patients will receive intraocular injection 0.3 mg ranibizumab |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
10 subjects were enrolled into each of the two ranibizumab groups (0.3 mg/ 0.5 mg)
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab 0.5 mg/ 0.05 cc | Intraocular injection of 0.5 mg /0.05 cc ranibizumab |
| BG001 | Ranibizumab 0.3 mg/ 0.05 cc | Intraocular injection of 0.3 mg /0.05 cc ranibizumab |
| 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 | Commonly Reported and Notable Adverse Events | Incidence and severity of ocular adverse events, as identified by indirect and direct examination. Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more of clinical macula (arcade to arcade), disease-related vitreous hemorrhage, injection-related endopthalmitis, 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 | participants | 2 years |
|
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 | Ranibizumab 0.5 mg | Intravitreal Injection of Ranibizumab 0.5 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flashes of Light | Eye disorders | Non-systematic Assessment | Subject sees flashes of light |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dennis M Marcus Principal Investigator | Southeast Retina Center, P.C. | 706-650-0061 | dmarcus@southeastretina.com |
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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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|
| BG002 | 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 |
|
Intraocular injection 0.3 mg ranibizumab
|
|
| 0 |
| 10 |
| 9 |
| 10 |
| EG001 | Ranibizumab 0.3 mg | Intravitreal Injection of Ranibizumab 0.5 mg | 0 | 10 | 8 | 10 |
| Worsening of Cataract | Eye disorders | Systematic Assessment |
|
| Injection Site Pain | Eye disorders | Non-systematic Assessment | Self-reported ocular pain at injection site immediately following injection |
|
| Itchy, Watery Eyes | Eye disorders | Non-systematic Assessment | Self-reported itchy, watery eyes caused by seasonal allergies |
|
| Vitreous Hemorrhage | Eye disorders | Systematic Assessment | Vitreous hemorrhage identified on clinical exam |
|
| Ocular Blurriness | Eye disorders | Non-systematic Assessment | Self-reported ocular blurriness |
|
| Macular Hole | Eye disorders | Systematic Assessment | Macular Hole identified on clinical exam |
|
| Increased Intraocular Pressure | Eye disorders | Systematic Assessment | Increased Intraocular Pressure identified on exam |
|
| Retinal Pigment Epithelial Changes | Eye disorders | Systematic Assessment | Retinal Pigment Epithelial Changes identified on clinical exam |
|
| Chalazion | Eye disorders | Systematic Assessment | Chalazion identified on clinical exam |
|
| Seeing Dark Spots | Eye disorders | Non-systematic Assessment | Dark spots in vision after injection reported by subject |
|
| Floaters | Eye disorders | Non-systematic Assessment | Self-reported floaters seen in vision after injection |
|
| Worsened Visual Acuity | Eye disorders | Systematic Assessment | Worsened Visual Acuity identified on exam |
|
| Eyelid Swelling | Eye disorders | Systematic Assessment | Eyelid swelling identified on exam after injection |
|
| Foreign Body Sensation | Eye disorders | Non-systematic Assessment | Foreign Body Sensation reported in eye by patient |
|
| Stye | Eye disorders | Systematic Assessment | Stye identified on clinical exam |
|
| Posterior Vitreous Detachment | Eye disorders | Systematic Assessment | Posterior Vitreous Detachment identified on clinical exam |
|
| Spider Webs in Vision | Eye disorders | Non-systematic Assessment | Spider webs in vision reported by subject after injection |
|
| Wavy Lines | Eye disorders | Non-systematic Assessment | Self reported wavy lines in vision |
|
| Worsened PCV | Eye disorders | Systematic Assessment | Active PCV identified on clinical exam |
|
| Worsened Night Vision | Eye disorders | Non-systematic Assessment | Worsened vision at night time reported by subject |
|
| Decreased color vision | Eye disorders | Non-systematic Assessment | Subject reported decreased ability to see colors |
|
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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 |