Polypoidal Choroidal Vasculopathy
Conditions
Keywords
polypoidal choroidal vasculopathy, choroidal neovascularization, ranibizumab, Lucentis
Brief summary
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.
Detailed description
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.
Interventions
DRUGranibizumab 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.
Sponsors
Genentech, Inc.
Southeast Retina Center, Georgia
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Males and Females \>18 years of age. Females of child bearing potential will undergo urine pregnancy testing and be required to use appropriate methods of birth control. * ICG and fluorescein angiographic characteristics consistent with active, leaking PCV with subfoveal lesions and/or subfoveal hemorrhage, lipid exudates, PED or fluid diagnosed within the past 6 months or diagnosed as newly active within the past 6 months. Subjects who completed the 24 month follow up in the original FVF3671s protocol may enter the study without necessarily demonstrating active exudative PCV at enrollment. * Best-Corrected ETDRS Visual Acuity at 4 meters between 20/20 - 20/800. * Lesion size - no limitations. * Lesions Characteristics - leaking lesions consistent with PCV. No limitations on hemorrhage, fibrosis or atrophy. * No therapy (includes non foveal laser, PDT, intravitreal steroids, TTT, radiotherapy, or anti-VEGF therapy) or intraocular surgery within the past 30 days for any condition. * Clear ocular media to allow for photography/angiography. * Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Exclusion criteria
* Patients with features of age related macular degeneration such as abundant drusen and demographic features consistent with this diagnosis. * Allergy to Fluorescein, ICG, Iodine, Shellfish. * Pregnancy (positive pregnancy test) * Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. * Participation in another simultaneous medical investigation or trial. * Exclude other anti-VEGF agents as therapy options. * History of previous subfoveal laser. * Advanced glaucoma (IOP \> 25 or cup/disc ration \> 0.8) * Any condition in the opinion of the investigator that would interfere with disease status/progression or jeopardize patients' participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 2 years | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Change in Mean Central Foveal Thickness From Baseline | 12 Months |
| 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 |
| Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months | 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 |
| Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 12 Months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 5 |
| Total | 20 |
Baseline characteristics
| Characteristic | Ranibizumab 0.5 mg | Total | Ranibizumab 1.0 or 2.0 mg (HIGH DOSE) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 16 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 20 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 8 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 11 Participants | 7 Participants |
| Region of Enrollment United States | 5 Participants | 20 Participants | 15 Participants |
| Sex: Female, Male Female | 2 Participants | 9 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 11 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 | 2 / 5 | 9 / 15 |
| serious Total, serious adverse events | 0 / 5 | 0 / 15 |
Outcome results
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.
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group: Ranibizumab 0.5mg | 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. | Injection site or ocular pain | 0 Adverse events |
| Control Group: Ranibizumab 0.5mg | 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. | Increased Choroidal Neovascularization | 0 Adverse events |
| Control Group: Ranibizumab 0.5mg | 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. | Blurred or decreased vision | 0 Adverse events |
| Control Group: Ranibizumab 0.5mg | 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. | Corneal abrasion | 0 Adverse events |
| Control Group: Ranibizumab 0.5mg | 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. | Increased Cataracts | 0 Adverse events |
| Control Group: Ranibizumab 0.5mg | 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. | Trace epiretinal membrane | 0 Adverse events |
| Control Group: Ranibizumab 0.5mg | 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. | Dark Spots | 0 Adverse events |
| Control Group: Ranibizumab 0.5mg | 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. | Flashes | 0 Adverse events |
| Control Group: Ranibizumab 0.5mg | 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. | Subretinal hemorrhage | 0 Adverse events |
| Control Group: Ranibizumab 0.5mg | 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. | Progression of edema | 0 Adverse events |
| Control Group: Ranibizumab 0.5mg | 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. | Floaters | 2 Adverse events |
| Control Group: Ranibizumab 0.5mg | 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. | Light sensitivity | 1 Adverse events |
| Control Group: Ranibizumab 0.5mg | 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. | Superior hemorrhage | 0 Adverse events |
| Control Group: Ranibizumab 0.5mg | 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. | Elevated blood pressure | 1 Adverse events |
| Control Group: Ranibizumab 0.5mg | 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. | Total Ocular and Notable Systemic AEs | 4 Adverse events |
| Ranibizumab 1.0mg or 2.0mg | 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. | Elevated blood pressure | 0 Adverse events |
| Ranibizumab 1.0mg or 2.0mg | 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. | Total Ocular and Notable Systemic AEs | 24 Adverse events |
| Ranibizumab 1.0mg or 2.0mg | 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. | Blurred or decreased vision | 6 Adverse events |
| Ranibizumab 1.0mg or 2.0mg | 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. | Floaters | 4 Adverse events |
| Ranibizumab 1.0mg or 2.0mg | 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. | Dark Spots | 3 Adverse events |
| Ranibizumab 1.0mg or 2.0mg | 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. | Injection site or ocular pain | 2 Adverse events |
| Ranibizumab 1.0mg or 2.0mg | 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. | Increased Cataracts | 2 Adverse events |
| Ranibizumab 1.0mg or 2.0mg | 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. | Subretinal hemorrhage | 1 Adverse events |
| Ranibizumab 1.0mg or 2.0mg | 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. | Superior hemorrhage | 1 Adverse events |
| Ranibizumab 1.0mg or 2.0mg | 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. | Increased Choroidal Neovascularization | 1 Adverse events |
| Ranibizumab 1.0mg or 2.0mg | 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. | Corneal abrasion | 1 Adverse events |
| Ranibizumab 1.0mg or 2.0mg | 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. | Trace epiretinal membrane | 1 Adverse events |
| Ranibizumab 1.0mg or 2.0mg | 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. | Flashes | 1 Adverse events |
| Ranibizumab 1.0mg or 2.0mg | 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. | Progression of edema | 1 Adverse events |
| Ranibizumab 1.0mg or 2.0mg | 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. | Light sensitivity | 0 Adverse events |
Comparison: Purpose was to determine safety and efficacy of intravitreal high-dose ranibizumab in the treatment of active PCV.p-value: 0.0595% CI: [0, 28]t-test, 2 sided
Secondary
Change in Mean Central Foveal Thickness From Baseline
Time frame: 12 Months
Population: Randomized in a 3:1 ratio
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Ranibizumab 0.5mg | Change in Mean Central Foveal Thickness From Baseline | -49.7 um | Standard Deviation 100.71 |
| Ranibizumab 1.0mg or 2.0mg | Change in Mean Central Foveal Thickness From Baseline | 94.4 um | Standard Deviation 89.6 |
Secondary
Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months
Time frame: 12 months
Population: Randomized in a 3:1 ratio - number in participant flow is 20
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Group: Ranibizumab 0.5mg | Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months | 6.7 letters |
| Ranibizumab 1.0mg or 2.0mg | Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months | -5 letters |
Secondary
Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12
Time frame: 12 months
Population: Randomized in a 3:1 ratio - number in participant flow is 20
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group: Ranibizumab 0.5mg | Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12 | Mean Change Baseline - M3 | 9.87 letters | Standard Deviation 15.27 |
| Control Group: Ranibizumab 0.5mg | Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12 | Mean Change Baseline - M6 | 10.23 letters | Standard Deviation 33.51 |
| Control Group: Ranibizumab 0.5mg | Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12 | Mean Change Baseline - M9 | 10.93 letters | Standard Deviation 43.81 |
| Control Group: Ranibizumab 0.5mg | Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12 | Mean Change Baseline - M12 | 6.37 letters | Standard Deviation 26.02 |
| Ranibizumab 1.0mg or 2.0mg | Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12 | Mean Change Baseline - M12 | -7.3 letters | Standard Deviation 20.11 |
| Ranibizumab 1.0mg or 2.0mg | Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12 | Mean Change Baseline - M3 | -2.8 letters | Standard Deviation 32.71 |
| Ranibizumab 1.0mg or 2.0mg | Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12 | Mean Change Baseline - M9 | -6.8 letters | Standard Deviation 9.08 |
| Ranibizumab 1.0mg or 2.0mg | Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12 | Mean Change Baseline - M6 | -3.6 letters | Standard Deviation 2.35 |
Secondary
Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months
Time frame: 12 Months
Population: Randomized in a 3:1 ratio
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Group: Ranibizumab 0.5mg | Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months | 2.38 mm^2 |
| Ranibizumab 1.0mg or 2.0mg | Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months | -0.38 mm^2 |
Secondary
Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
Time frame: 12 Months
Population: Randomized in a 3:1 ratio - number in participant flow is 20
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 5 letters | 4 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 10 letters | 1 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 15 letters | 3 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 5 letters | 1 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 10 letters | 0 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 15 letters | 0 Participants |
Secondary
Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
Time frame: 12 months
Population: Randomized in a 3:1 ratio - number in participant flow is 20
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 5 letters | 0 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 10 letters | 0 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 15 letters | 0 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 5 letters | 1 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 10 letters | 0 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 15 letters | 1 Participants |
Secondary
Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
Time frame: 3 Months
Population: Randomized in a 3:1 ratio - number in participant flow is 20
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 10-14 letters | 2 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | Less than 5 letters | 6 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 15 letters or more | 3 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | Unevaluable | 1 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 5-9 letters | 3 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | Unevaluable | 0 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 5-9 letters | 0 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 10-14 letters | 0 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 15 letters or more | 0 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | Less than 5 letters | 0 Participants |
Secondary
Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
Time frame: 3 months
Population: Randomized in a 3:1 ratio - number in participant flow is 20
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 5 letters | 1 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 10 letters | 0 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 15 letters | 1 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 5 letters | 0 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 10 letters | 0 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 15 letters | 1 Participants |
Secondary
Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
Time frame: 6 months
Population: Randomized in a 3:1 ratio - number in participant flow is 20
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 5 letters | 3 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 10 letters | 1 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 15 or more letters | 4 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 5 letters | 1 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 10 letters | 0 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 15 or more letters | 0 Participants |
Secondary
Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
Time frame: 6 months
Population: Randomized in a 3:1 ratio - number in participant flow is 20
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 5 letters | 0 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 10 letters | 0 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 15 letters | 1 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 5 letters | 1 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 10 letters | 1 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 15 letters | 0 Participants |
Secondary
Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
Time frame: 9 Months
Population: Randomized in a 3:1 ratio - number in participant flow is 20
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 5 letters | 3 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 10 letters | 3 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 15 letters | 2 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 5 letters | 0 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 10 letters | 0 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 15 letters | 0 Participants |
Secondary
Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
Time frame: 9 months
Population: Randomized in a 3:1 ratio - number in participant flow is 20
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 5 letters | 0 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 10 letters | 0 Participants |
| Control Group: Ranibizumab 0.5mg | Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 15 letters | 1 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 5 letters | 0 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 10 letters | 0 Participants |
| Ranibizumab 1.0mg or 2.0mg | Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 15 letters | 1 Participants |