Macular Edema, Retinal Vein Occlusion
Conditions
Keywords
CNV, Lucentis, AMD, Age-related macular degeneration, RVO, Macular edema secondary to retinal vein occlusion
Brief summary
This is an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g, NCT00379795) enrolled subjects with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort (reported here) enrolled subjects with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). Patients were enrolled within 14 days of completion of the previous study.
Interventions
Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year).
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent form * The 6-month treatment and 6-month observation phases (12 months total) of a Genentech-sponsored ranibizumab study for RVO (FVF4165g or FVF4166g) * Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment
Exclusion criteria
* History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 1 month prior to Day 0 of this extension study * Concurrent use of systemic anti-VEGF agents * Use of RVO treatments not approved by the Food and Drug Administration (FDA) in the study eye * Use of intravitreal bevacizumab in the study eye and/or fellow eye * Macular edema in the study eye due to other causes than RVO such as diabetes * History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye * History of idiopathic or autoimmune-associated uveitis in either eye * Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 30 mmHg despite treatment with antiglaucoma medication) * Pregnancy or lactation * Premenopausal women not using adequate contraception * History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications * Current treatment for active systemic infection * Inability to comply with study or follow-up procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Ocular Adverse Events in the Study Eye | Up to 24 months | Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study eye. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded. |
| Number of Participants With Non-ocular Adverse Events | Up to 24 months | Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded. Additional information about adverse events can be found in the adverse events section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Baseline (Day 0 of extension study), Months 6, 12, 18, and 24 | Change from baseline in then BCVA was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a Starting Test Distance of 4 Meters. An increase in the number of letters read indicates improvement in visual acuity. |
| Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Baseline (Day 0 of extension study), Months 6 and 12 | Change from baseline in Central foveal (retinal) thickness was assessed by Optical Coherence Tomography (OCT). OCT was conducted at the study sites by personnel who were certified by the University of Wisconsin Fundus Photograph Reading Center. |
| Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | Baseline (Day 0 of extension study), Months 12 and 24 | NEI VFQ-25 is a 25 item questionnaire that assesses visual function and quality of life for a total possible score of 0 to 100. A higher score represents better functioning. The change from baseline is calculated at Month 12 and Month 24. Participants are grouped according to the treatment they received in initial studies FVF4165g BRAVO (NCT00486018) and FVF4166g CRUISE (NCT00485836). |
Participant flow
Recruitment details
This is an open label multi-center extension study for participants who completed FVF4165g BRAVO (NCT00486018) or FVF4166g CRUISE (NCT0048583). Cohort 2 consists of enrolled participants with macular edema secondary to retinal vein occlusion (RVO).
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab (Sham BRAVO) In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study. | 97 |
| Ranibizumab (0.3 mg BRAVO) In this extension study participant received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO. | 103 |
| Ranibizumab (0.5 mg BRAVO) In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO. | 104 |
| Ranibizumab (Sham CRUISE) In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study. | 98 |
| Ranibizumab (0.3 mg CRUISE) In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE. | 107 |
| Ranibizumab (0.5 mg CRUISE) In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE. | 99 |
| Total | 608 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 2 | 1 | 2 | 0 |
| Overall Study | Condition mandated other intervention | 1 | 1 | 2 | 0 | 0 | 2 |
| Overall Study | Death | 0 | 1 | 3 | 3 | 1 | 3 |
| Overall Study | Lost to Follow-up | 5 | 5 | 1 | 1 | 3 | 3 |
| Overall Study | Physician Decision | 1 | 1 | 2 | 3 | 3 | 1 |
| Overall Study | Sponsor decision | 82 | 88 | 92 | 88 | 95 | 87 |
| Overall Study | Subject non-compliance | 0 | 0 | 0 | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 3 | 2 | 2 | 2 | 1 |
Baseline characteristics
| Characteristic | Ranibizumab (Sham BRAVO) | Ranibizumab (0.3 mg BRAVO) | Ranibizumab (0.5 mg BRAVO) | Ranibizumab (Sham CRUISE) | Ranibizumab (0.3 mg CRUISE) | Ranibizumab (0.5 mg CRUISE) | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized 45 to <65 years | 43 participants | 39 participants | 38 participants | 37 participants | 26 participants | 32 participants | 215 participants |
| Age, Customized <45 years | 5 participants | 3 participants | 3 participants | 8 participants | 3 participants | 4 participants | 26 participants |
| Age, Customized 65 to <85 years | 45 participants | 54 participants | 55 participants | 49 participants | 68 participants | 59 participants | 330 participants |
| Age, Customized ≥85 years | 4 participants | 7 participants | 8 participants | 4 participants | 10 participants | 4 participants | 37 participants |
| Sex: Female, Male Female | 43 Participants | 57 Participants | 46 Participants | 41 Participants | 52 Participants | 39 Participants | 278 Participants |
| Sex: Female, Male Male | 54 Participants | 46 Participants | 58 Participants | 57 Participants | 55 Participants | 60 Participants | 330 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 146 / 189 | 179 / 210 | 172 / 203 |
| serious Total, serious adverse events | 32 / 189 | 49 / 210 | 46 / 203 |
Outcome results
Primary
Number of Participants With Non-ocular Adverse Events
Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded. Additional information about adverse events can be found in the adverse events section.
Time frame: Up to 24 months
Population: Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab (Sham BRAVO) | Number of Participants With Non-ocular Adverse Events | Any non-ocular adverse event | 56 participants |
| Ranibizumab (Sham BRAVO) | Number of Participants With Non-ocular Adverse Events | Serious non-ocular adverse event | 10 participants |
| Ranibizumab (Sham BRAVO) | Number of Participants With Non-ocular Adverse Events | Non-ocular adverse event led to discontinuation | 1 participants |
| Ranibizumab (Sham BRAVO) | Number of Participants With Non-ocular Adverse Events | Death | 0 participants |
| Ranibizumab (0.3 mg BRAVO) | Number of Participants With Non-ocular Adverse Events | Non-ocular adverse event led to discontinuation | 0 participants |
| Ranibizumab (0.3 mg BRAVO) | Number of Participants With Non-ocular Adverse Events | Serious non-ocular adverse event | 15 participants |
| Ranibizumab (0.3 mg BRAVO) | Number of Participants With Non-ocular Adverse Events | Any non-ocular adverse event | 77 participants |
| Ranibizumab (0.3 mg BRAVO) | Number of Participants With Non-ocular Adverse Events | Death | 1 participants |
| Ranibizumab (0.5 mg BRAVO) | Number of Participants With Non-ocular Adverse Events | Death | 3 participants |
| Ranibizumab (0.5 mg BRAVO) | Number of Participants With Non-ocular Adverse Events | Non-ocular adverse event led to discontinuation | 1 participants |
| Ranibizumab (0.5 mg BRAVO) | Number of Participants With Non-ocular Adverse Events | Serious non-ocular adverse event | 18 participants |
| Ranibizumab (0.5 mg BRAVO) | Number of Participants With Non-ocular Adverse Events | Any non-ocular adverse event | 68 participants |
| Ranibizumab (Sham CRUISE) | Number of Participants With Non-ocular Adverse Events | Any non-ocular adverse event | 58 participants |
| Ranibizumab (Sham CRUISE) | Number of Participants With Non-ocular Adverse Events | Death | 3 participants |
| Ranibizumab (Sham CRUISE) | Number of Participants With Non-ocular Adverse Events | Serious non-ocular adverse event | 16 participants |
| Ranibizumab (Sham CRUISE) | Number of Participants With Non-ocular Adverse Events | Non-ocular adverse event led to discontinuation | 0 participants |
| Ranibizumab (0.3 mg CRUISE) | Number of Participants With Non-ocular Adverse Events | Non-ocular adverse event led to discontinuation | 1 participants |
| Ranibizumab (0.3 mg CRUISE) | Number of Participants With Non-ocular Adverse Events | Death | 1 participants |
| Ranibizumab (0.3 mg CRUISE) | Number of Participants With Non-ocular Adverse Events | Serious non-ocular adverse event | 21 participants |
| Ranibizumab (0.3 mg CRUISE) | Number of Participants With Non-ocular Adverse Events | Any non-ocular adverse event | 71 participants |
| Ranibizumab (0.5 mg CRUISE) | Number of Participants With Non-ocular Adverse Events | Serious non-ocular adverse event | 20 participants |
| Ranibizumab (0.5 mg CRUISE) | Number of Participants With Non-ocular Adverse Events | Non-ocular adverse event led to discontinuation | 0 participants |
| Ranibizumab (0.5 mg CRUISE) | Number of Participants With Non-ocular Adverse Events | Death | 3 participants |
| Ranibizumab (0.5 mg CRUISE) | Number of Participants With Non-ocular Adverse Events | Any non-ocular adverse event | 64 participants |
Primary
Number of Participants With Ocular Adverse Events in the Study Eye
Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study eye. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.
Time frame: Up to 24 months
Population: Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab (Sham BRAVO) | Number of Participants With Ocular Adverse Events in the Study Eye | Intraocular inflammation | 0 participants |
| Ranibizumab (Sham BRAVO) | Number of Participants With Ocular Adverse Events in the Study Eye | Ocular AE leading to treatment discontinuation | 1 participants |
| Ranibizumab (Sham BRAVO) | Number of Participants With Ocular Adverse Events in the Study Eye | Any ocular adverse event (AE) | 51 participants |
| Ranibizumab (Sham BRAVO) | Number of Participants With Ocular Adverse Events in the Study Eye | Cataract | 6 participants |
| Ranibizumab (Sham BRAVO) | Number of Participants With Ocular Adverse Events in the Study Eye | Ocular serious adverse event | 2 participants |
| Ranibizumab (0.3 mg BRAVO) | Number of Participants With Ocular Adverse Events in the Study Eye | Ocular AE leading to treatment discontinuation | 2 participants |
| Ranibizumab (0.3 mg BRAVO) | Number of Participants With Ocular Adverse Events in the Study Eye | Intraocular inflammation | 0 participants |
| Ranibizumab (0.3 mg BRAVO) | Number of Participants With Ocular Adverse Events in the Study Eye | Any ocular adverse event (AE) | 64 participants |
| Ranibizumab (0.3 mg BRAVO) | Number of Participants With Ocular Adverse Events in the Study Eye | Cataract | 10 participants |
| Ranibizumab (0.3 mg BRAVO) | Number of Participants With Ocular Adverse Events in the Study Eye | Ocular serious adverse event | 4 participants |
| Ranibizumab (0.5 mg BRAVO) | Number of Participants With Ocular Adverse Events in the Study Eye | Ocular AE leading to treatment discontinuation | 2 participants |
| Ranibizumab (0.5 mg BRAVO) | Number of Participants With Ocular Adverse Events in the Study Eye | Intraocular inflammation | 0 participants |
| Ranibizumab (0.5 mg BRAVO) | Number of Participants With Ocular Adverse Events in the Study Eye | Cataract | 6 participants |
| Ranibizumab (0.5 mg BRAVO) | Number of Participants With Ocular Adverse Events in the Study Eye | Ocular serious adverse event | 6 participants |
| Ranibizumab (0.5 mg BRAVO) | Number of Participants With Ocular Adverse Events in the Study Eye | Any ocular adverse event (AE) | 63 participants |
| Ranibizumab (Sham CRUISE) | Number of Participants With Ocular Adverse Events in the Study Eye | Ocular serious adverse event | 5 participants |
| Ranibizumab (Sham CRUISE) | Number of Participants With Ocular Adverse Events in the Study Eye | Any ocular adverse event (AE) | 60 participants |
| Ranibizumab (Sham CRUISE) | Number of Participants With Ocular Adverse Events in the Study Eye | Ocular AE leading to treatment discontinuation | 0 participants |
| Ranibizumab (Sham CRUISE) | Number of Participants With Ocular Adverse Events in the Study Eye | Intraocular inflammation | 2 participants |
| Ranibizumab (Sham CRUISE) | Number of Participants With Ocular Adverse Events in the Study Eye | Cataract | 3 participants |
| Ranibizumab (0.3 mg CRUISE) | Number of Participants With Ocular Adverse Events in the Study Eye | Intraocular inflammation | 3 participants |
| Ranibizumab (0.3 mg CRUISE) | Number of Participants With Ocular Adverse Events in the Study Eye | Any ocular adverse event (AE) | 67 participants |
| Ranibizumab (0.3 mg CRUISE) | Number of Participants With Ocular Adverse Events in the Study Eye | Cataract | 6 participants |
| Ranibizumab (0.3 mg CRUISE) | Number of Participants With Ocular Adverse Events in the Study Eye | Ocular AE leading to treatment discontinuation | 2 participants |
| Ranibizumab (0.3 mg CRUISE) | Number of Participants With Ocular Adverse Events in the Study Eye | Ocular serious adverse event | 10 participants |
| Ranibizumab (0.5 mg CRUISE) | Number of Participants With Ocular Adverse Events in the Study Eye | Any ocular adverse event (AE) | 66 participants |
| Ranibizumab (0.5 mg CRUISE) | Number of Participants With Ocular Adverse Events in the Study Eye | Intraocular inflammation | 1 participants |
| Ranibizumab (0.5 mg CRUISE) | Number of Participants With Ocular Adverse Events in the Study Eye | Ocular AE leading to treatment discontinuation | 2 participants |
| Ranibizumab (0.5 mg CRUISE) | Number of Participants With Ocular Adverse Events in the Study Eye | Cataract | 5 participants |
| Ranibizumab (0.5 mg CRUISE) | Number of Participants With Ocular Adverse Events in the Study Eye | Ocular serious adverse event | 3 participants |
Secondary
Change From Baseline in Central Foveal Thickness at Month 6 and Month 12
Change from baseline in Central foveal (retinal) thickness was assessed by Optical Coherence Tomography (OCT). OCT was conducted at the study sites by personnel who were certified by the University of Wisconsin Fundus Photograph Reading Center.
Time frame: Baseline (Day 0 of extension study), Months 6 and 12
Population: Enrolled participants for whom data was available for analyses at the given time-point as indicated by n in the categories. Observed data were used with no imputation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab (Sham BRAVO) | Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Month 6 (n=86,96,97,90,101,89) | 21.5 µm | Standard Deviation 131.6 |
| Ranibizumab (Sham BRAVO) | Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Month 12 (n=62,65,72,56,69,51) | 3.7 µm | Standard Deviation 124.9 |
| Ranibizumab (0.3 mg BRAVO) | Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Month 6 (n=86,96,97,90,101,89) | 36.8 µm | Standard Deviation 159.8 |
| Ranibizumab (0.3 mg BRAVO) | Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Month 12 (n=62,65,72,56,69,51) | 6.3 µm | Standard Deviation 163.7 |
| Ranibizumab (0.5 mg BRAVO) | Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Month 6 (n=86,96,97,90,101,89) | 40.2 µm | Standard Deviation 117.4 |
| Ranibizumab (0.5 mg BRAVO) | Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Month 12 (n=62,65,72,56,69,51) | 35.3 µm | Standard Deviation 110.6 |
| Ranibizumab (Sham CRUISE) | Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Month 6 (n=86,96,97,90,101,89) | 87.4 µm | Standard Deviation 217.1 |
| Ranibizumab (Sham CRUISE) | Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Month 12 (n=62,65,72,56,69,51) | 79.7 µm | Standard Deviation 199.4 |
| Ranibizumab (0.3 mg CRUISE) | Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Month 6 (n=86,96,97,90,101,89) | 161.4 µm | Standard Deviation 289.1 |
| Ranibizumab (0.3 mg CRUISE) | Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Month 12 (n=62,65,72,56,69,51) | 88.3 µm | Standard Deviation 262.9 |
| Ranibizumab (0.5 mg CRUISE) | Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Month 6 (n=86,96,97,90,101,89) | 94.6 µm | Standard Deviation 235.9 |
| Ranibizumab (0.5 mg CRUISE) | Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Month 12 (n=62,65,72,56,69,51) | 68.4 µm | Standard Deviation 252.7 |
Secondary
Change From Baseline in the Best Corrected Visual Acuity (BCVA)
Change from baseline in then BCVA was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a Starting Test Distance of 4 Meters. An increase in the number of letters read indicates improvement in visual acuity.
Time frame: Baseline (Day 0 of extension study), Months 6, 12, 18, and 24
Population: Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab (Sham BRAVO) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 6 (n=88,96,98,90,101,91) | -0.1 letters | Standard Deviation 8.1 |
| Ranibizumab (Sham BRAVO) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 12 (n=66,66,73,58,69,50) | 0.9 letters | Standard Deviation 6.9 |
| Ranibizumab (Sham BRAVO) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 18 (n=23,26,32,31,26,22) | 0.5 letters | Standard Deviation 5 |
| Ranibizumab (Sham BRAVO) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 24 (n=0,2,0,0,1,0) | NA letters | — |
| Ranibizumab (0.3 mg BRAVO) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 18 (n=23,26,32,31,26,22) | -1.7 letters | Standard Deviation 6.3 |
| Ranibizumab (0.3 mg BRAVO) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 12 (n=66,66,73,58,69,50) | -2.3 letters | Standard Deviation 11.5 |
| Ranibizumab (0.3 mg BRAVO) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 6 (n=88,96,98,90,101,91) | -2.2 letters | Standard Deviation 10.5 |
| Ranibizumab (0.3 mg BRAVO) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 24 (n=0,2,0,0,1,0) | -4.5 letters | Standard Deviation 16.3 |
| Ranibizumab (0.5 mg BRAVO) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 24 (n=0,2,0,0,1,0) | NA letters | — |
| Ranibizumab (0.5 mg BRAVO) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 18 (n=23,26,32,31,26,22) | -6.1 letters | Standard Deviation 15.5 |
| Ranibizumab (0.5 mg BRAVO) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 12 (n=66,66,73,58,69,50) | -0.7 letters | Standard Deviation 7.3 |
| Ranibizumab (0.5 mg BRAVO) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 6 (n=88,96,98,90,101,91) | -1.3 letters | Standard Deviation 7.1 |
| Ranibizumab (Sham CRUISE) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 6 (n=88,96,98,90,101,91) | -3.2 letters | Standard Deviation 10.4 |
| Ranibizumab (Sham CRUISE) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 24 (n=0,2,0,0,1,0) | NA letters | — |
| Ranibizumab (Sham CRUISE) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 12 (n=66,66,73,58,69,50) | -4.2 letters | Standard Deviation 11.3 |
| Ranibizumab (Sham CRUISE) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 18 (n=23,26,32,31,26,22) | -5.1 letters | Standard Deviation 14.6 |
| Ranibizumab (0.3 mg CRUISE) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 18 (n=23,26,32,31,26,22) | -6.1 letters | Standard Deviation 12.1 |
| Ranibizumab (0.3 mg CRUISE) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 24 (n=0,2,0,0,1,0) | -1.0 letters | — |
| Ranibizumab (0.3 mg CRUISE) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 12 (n=66,66,73,58,69,50) | -5.2 letters | Standard Deviation 13.8 |
| Ranibizumab (0.3 mg CRUISE) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 6 (n=88,96,98,90,101,91) | -4.1 letters | Standard Deviation 10.7 |
| Ranibizumab (0.5 mg CRUISE) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 12 (n=66,66,73,58,69,50) | -4.1 letters | Standard Deviation 12.9 |
| Ranibizumab (0.5 mg CRUISE) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 18 (n=23,26,32,31,26,22) | -0.8 letters | Standard Deviation 10.9 |
| Ranibizumab (0.5 mg CRUISE) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 24 (n=0,2,0,0,1,0) | NA letters | — |
| Ranibizumab (0.5 mg CRUISE) | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Month 6 (n=88,96,98,90,101,91) | -3.2 letters | Standard Deviation 9.7 |
Secondary
Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)
NEI VFQ-25 is a 25 item questionnaire that assesses visual function and quality of life for a total possible score of 0 to 100. A higher score represents better functioning. The change from baseline is calculated at Month 12 and Month 24. Participants are grouped according to the treatment they received in initial studies FVF4165g BRAVO (NCT00486018) and FVF4166g CRUISE (NCT00485836).
Time frame: Baseline (Day 0 of extension study), Months 12 and 24
Population: Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab (Sham BRAVO) | Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | Month 12 (n=64,65,72,58,67,50) | -0.3 Scores on a scale | Standard Deviation 10 |
| Ranibizumab (Sham BRAVO) | Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | Month 24 (n=0,2,0,0,1,0) | NA Scores on a scale | — |
| Ranibizumab (0.3 mg BRAVO) | Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | Month 12 (n=64,65,72,58,67,50) | -0.7 Scores on a scale | Standard Deviation 9.7 |
| Ranibizumab (0.3 mg BRAVO) | Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | Month 24 (n=0,2,0,0,1,0) | 6.2 Scores on a scale | Standard Deviation 7.4 |
| Ranibizumab (0.5 mg BRAVO) | Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | Month 12 (n=64,65,72,58,67,50) | -0.7 Scores on a scale | Standard Deviation 8.6 |
| Ranibizumab (0.5 mg BRAVO) | Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | Month 24 (n=0,2,0,0,1,0) | NA Scores on a scale | — |
| Ranibizumab (Sham CRUISE) | Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | Month 12 (n=64,65,72,58,67,50) | 0.1 Scores on a scale | Standard Deviation 10.5 |
| Ranibizumab (Sham CRUISE) | Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | Month 24 (n=0,2,0,0,1,0) | NA Scores on a scale | — |
| Ranibizumab (0.3 mg CRUISE) | Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | Month 12 (n=64,65,72,58,67,50) | -1.0 Scores on a scale | Standard Deviation 8 |
| Ranibizumab (0.3 mg CRUISE) | Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | Month 24 (n=0,2,0,0,1,0) | -13.3 Scores on a scale | — |
| Ranibizumab (0.5 mg CRUISE) | Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | Month 12 (n=64,65,72,58,67,50) | -1.6 Scores on a scale | Standard Deviation 7.7 |
| Ranibizumab (0.5 mg CRUISE) | Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | Month 24 (n=0,2,0,0,1,0) | NA Scores on a scale | — |