Polypoidal Choroidal Vasculopathy
Conditions
Keywords
polypoidal choroidal vasculopathy, choroidal neovascularization, ranibizumab, Lucentis
Brief summary
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.
Detailed description
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).
Interventions
DRUGranibizumab 0.5 or 0.3 mg/0.05 cc
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
Sponsors
Genentech, Inc.
Southeast Retina Center, Georgia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \>35 years * Exudative, active 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.
Exclusion criteria
* Age \<35 years * Prior treatment with non-ranibizumab therapies (e.g., laser, surgery, or bevacizumab)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Commonly Reported and Notable Adverse Events | 2 years | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab 0.5 mg/ 0.05 cc Intraocular injection of 0.5 mg /0.05 cc ranibizumab | 10 |
| Ranibizumab 0.3 mg/ 0.05 cc Intraocular injection of 0.3 mg /0.05 cc ranibizumab | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | Ranibizumab 0.3 mg/ 0.05 cc | Ranibizumab 0.5 mg/ 0.05 cc | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 6 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 4 Participants | 11 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 8 | 64 years STANDARD_DEVIATION 14 | 64 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 10 | 8 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Transient increased blood pressure | 0 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Retinal Pigment epithelial changes | 0 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Floaters | 4 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Injection-related pain | 2 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Macular hole | 0 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Eye pain, burning | 2 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Transient increased intraocular pressure | 0 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Worsening visual acuity | 2 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Chalazion | 1 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Wavy Lines | 1 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Stye | 2 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Eye irritation | 1 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Decreased color vision | 0 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Injection-related eyelid swelling | 2 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Foreign Body Sensation | 1 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Mild Vitreous Hemorrhage | 1 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Posterior Vitreous detachment | 0 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Seeing Dark spots | 2 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Blurry vision | 2 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Worsened Night Vision | 1 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Spider webs | 1 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Worsened polypoidal choroidal vasculopathy | 1 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Eyelid swelling | 2 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Worsening of Cataracts | 1 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Itchy, watery eyes | 1 participants |
| Ranibizumab 0.5 mg | Commonly Reported and Notable Adverse Events | Flashes of Light | 1 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Itchy, watery eyes | 2 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Worsening of Cataracts | 2 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Spider webs | 2 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Wavy Lines | 2 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Seeing Dark spots | 2 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Flashes of Light | 1 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Floaters | 1 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Worsening visual acuity | 1 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Eye irritation | 2 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Mild Vitreous Hemorrhage | 2 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Blurry vision | 3 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Eyelid swelling | 1 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Transient increased blood pressure | 2 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Injection-related pain | 3 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Injection-related eyelid swelling | 1 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Macular hole | 1 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Transient increased intraocular pressure | 1 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Chalazion | 0 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Stye | 0 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Decreased color vision | 1 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Foreign Body Sensation | 0 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Posterior Vitreous detachment | 1 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Retinal Pigment epithelial changes | 1 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Worsened Night Vision | 0 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Worsened polypoidal choroidal vasculopathy | 0 participants |
| Ranibizumab 0.3 mg | Commonly Reported and Notable Adverse Events | Eye pain, burning | 3 participants |