Choroidal Neovascularization, Age-related Macular Degeneration
Conditions
Keywords
CNV, Lucentis, AMD, Age-related macular degeneration, RVO
Brief summary
This was an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported here) enrolled patients 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 enrolled patients 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)). The results of the second cohort are reported separately (NCT01442064). The first cohort of this study enrolled two subsets of patients: ranibizumab experienced and ranibizumab-naive. Patients were enrolled within 14 days of completion of the 24 month treatment phase 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
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent form. * Completion of the treatment phase (through Month 24) of a Genentech-sponsored ranibizumab study for AMD (FVF2598g, FVF2587g, or FVF2428g) (Cohort 1) * Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment
Exclusion criteria
* Previous subfoveal focal laser photocoagulation in the study eye * Previous pegaptanib sodium injection in the study eye * Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0 of this extension study * History of submacular surgery or other surgical intervention for AMD in the study eye * History of glaucoma filtering surgery in the study eye * History of corneal transplant in the study eye * Concurrent use of systemic anti-EGF agents * Use of AMD treatments not approved by the FDA * Use of intravitreal Avastin(R) (bevacizumab) in the study eye and/or fellow eye * CNV in either eye due to other causes than AMD, such as ocular histoplasmosis, trauma, or pathologic myopia for Cohort 1 * 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 | 36 months | Number of participants with ocular adverse events in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation, endophthalmitis and intraocular inflammation that occurred in the study eye (the eye that received all study drug injections) and the fellow eye (other 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 | 36 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. |
| Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24 | Month 12 and 24 | Serum samples for the evaluation of antibodies to Ranibizumab were collected at Month 12 and Month 24 and were sent to a reference laboratory for analysis. If an injection of Ranibizumab was required at the visit, the samples were collected prior to the injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 | Change from baseline in Best corrected visual acuity (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 2 meters. An increase in the number of letters read indicates improvement in visual acuity. |
| Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters | Extension study baseline, Months 12 and 24 | Change from baseline in Best corrected visual acuity (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. |
Participant flow
Recruitment details
This is an open label multicenter extension study for participants who have completed one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823). Cohort 1 includes patients with Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD).
Pre-assignment details
Participants were classified according to ranibizumab exposure in the previous study and in the extension study. 63 participants (Untreated Group) did not receive study drug in this extension study or in the previous studies and are not included in the safety analyses.
Participants by arm
| Arm | Count |
|---|---|
| RanibizumabTreated Initial Mono In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab 0.5 mg monotherapy, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g. | 526 |
| RanibizumabTreated Initial + PDT In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injections in combination with photodynamic therapy in Study FVF2428g. | 74 |
| RanibizumabTreated Sham XO In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5mg intravitreal injections in previous study FVF2598g or in this extension study. | 116 |
| Ranibizumab Treated PDT XO In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injections in previous studies FVF2428g, study FVF2587g or this extension study. | 74 |
| Ranibizumab Untreated Group In this extension study participants did not receive Ranibizumab. Participants in this group were previously enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594), FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or in this extension study (FVF3426g). | 63 |
| Total | 853 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 17 | 3 | 3 | 1 | 4 |
| Overall Study | Death | 31 | 8 | 6 | 4 | 7 |
| Overall Study | Lost to Follow-up | 8 | 1 | 2 | 1 | 4 |
| Overall Study | Physician Decision | 25 | 0 | 2 | 2 | 2 |
| Overall Study | Sponsor's decision | 257 | 17 | 54 | 47 | 10 |
| Overall Study | Subject non-compliance | 7 | 2 | 0 | 0 | 1 |
| Overall Study | Subjects condition mandated intervention | 34 | 9 | 7 | 5 | 7 |
| Overall Study | Verteporfin photodynamic therapy in eye | 3 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 94 | 11 | 19 | 7 | 14 |
Baseline characteristics
| Characteristic | RanibizumabTreated Initial Mono | RanibizumabTreated Initial + PDT | RanibizumabTreated Sham XO | Ranibizumab Treated PDT XO | Ranibizumab Untreated Group | Total |
|---|---|---|---|---|---|---|
| Age, Customized 50 to < 65 | 29 participants | 5 participants | 5 participants | 8 participants | 4 participants | 51 participants |
| Age, Customized 65 to < 75 | 117 participants | 19 participants | 27 participants | 21 participants | 10 participants | 194 participants |
| Age, Customized 75 to < 85 | 277 participants | 42 participants | 61 participants | 35 participants | 29 participants | 444 participants |
| Age, Customized >= 85 | 103 participants | 8 participants | 23 participants | 10 participants | 20 participants | 164 participants |
| Sex: Female, Male Female | 304 Participants | 42 Participants | 76 Participants | 41 Participants | 36 Participants | 499 Participants |
| Sex: Female, Male Male | 222 Participants | 32 Participants | 40 Participants | 33 Participants | 27 Participants | 354 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 491 / 526 | 70 / 74 | 110 / 116 | 71 / 74 |
| serious Total, serious adverse events | 213 / 526 | 26 / 74 | 43 / 116 | 24 / 74 |
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: 36 months
Population: Enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab Treated Initial Mono | Number of Participants With Non-ocular Adverse Events | Any non ocular adverse event | 427 participants |
| Ranibizumab Treated Initial Mono | Number of Participants With Non-ocular Adverse Events | Death | 31 participants |
| Ranibizumab Treated Initial Mono | Number of Participants With Non-ocular Adverse Events | Serious non ocular adverse event | 169 participants |
| Ranibizumab Treated Initial Mono | Number of Participants With Non-ocular Adverse Events | Non ocular adverse events led to discontinuation | 27 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Non-ocular Adverse Events | Serious non ocular adverse event | 21 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Non-ocular Adverse Events | Non ocular adverse events led to discontinuation | 2 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Non-ocular Adverse Events | Any non ocular adverse event | 61 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Non-ocular Adverse Events | Death | 8 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Non-ocular Adverse Events | Serious non ocular adverse event | 33 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Non-ocular Adverse Events | Death | 6 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Non-ocular Adverse Events | Any non ocular adverse event | 92 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Non-ocular Adverse Events | Non ocular adverse events led to discontinuation | 1 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Non-ocular Adverse Events | Death | 4 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Non-ocular Adverse Events | Non ocular adverse events led to discontinuation | 0 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Non-ocular Adverse Events | Any non ocular adverse event | 58 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Non-ocular Adverse Events | Serious non ocular adverse event | 20 participants |
Primary
Number of Participants With Ocular Adverse Events
Number of participants with ocular adverse events in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation, endophthalmitis and intraocular inflammation that occurred in the study eye (the eye that received all study drug injections) and the fellow eye (other 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: 36 months
Population: All enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab Treated Initial Mono | Number of Participants With Ocular Adverse Events | Endophthalmitis in fellow eye | 0 participants |
| Ranibizumab Treated Initial Mono | Number of Participants With Ocular Adverse Events | Serious intraocular inflammation in fellow eye | 1 participants |
| Ranibizumab Treated Initial Mono | Number of Participants With Ocular Adverse Events | Serious adverse events in fellow eye | 22 participants |
| Ranibizumab Treated Initial Mono | Number of Participants With Ocular Adverse Events | Any adverse event in study eye | 418 participants |
| Ranibizumab Treated Initial Mono | Number of Participants With Ocular Adverse Events | Adverse events led to discontinuation, fellow eye | 6 participants |
| Ranibizumab Treated Initial Mono | Number of Participants With Ocular Adverse Events | Adverse events led to discontinuation, study eye | 7 participants |
| Ranibizumab Treated Initial Mono | Number of Participants With Ocular Adverse Events | Endophthalmitis in study eye | 1 participants |
| Ranibizumab Treated Initial Mono | Number of Participants With Ocular Adverse Events | Serious adverse events in study eye | 46 participants |
| Ranibizumab Treated Initial Mono | Number of Participants With Ocular Adverse Events | Intraocular inflammation in fellow eye, total | 5 participants |
| Ranibizumab Treated Initial Mono | Number of Participants With Ocular Adverse Events | Intraocular inflammation in study eye, total | 8 participants |
| Ranibizumab Treated Initial Mono | Number of Participants With Ocular Adverse Events | Serious Intraocular inflammation in study eye | 1 participants |
| Ranibizumab Treated Initial Mono | Number of Participants With Ocular Adverse Events | Any adverse event in fellow eye | 304 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Ocular Adverse Events | Serious adverse events in study eye | 2 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Ocular Adverse Events | Any adverse event in fellow eye | 50 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Ocular Adverse Events | Endophthalmitis in study eye | 0 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Ocular Adverse Events | Adverse events led to discontinuation, fellow eye | 7 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Ocular Adverse Events | Endophthalmitis in fellow eye | 0 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Ocular Adverse Events | Serious adverse events in fellow eye | 4 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Ocular Adverse Events | Any adverse event in study eye | 56 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Ocular Adverse Events | Serious Intraocular inflammation in study eye | 0 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Ocular Adverse Events | Intraocular inflammation in study eye, total | 2 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Ocular Adverse Events | Adverse events led to discontinuation, study eye | 2 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Ocular Adverse Events | Serious intraocular inflammation in fellow eye | 0 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Ocular Adverse Events | Intraocular inflammation in fellow eye, total | 0 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Ocular Adverse Events | Serious adverse events in fellow eye | 6 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Ocular Adverse Events | Any adverse event in study eye | 96 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Ocular Adverse Events | Serious adverse events in study eye | 6 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Ocular Adverse Events | Adverse events led to discontinuation, study eye | 3 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Ocular Adverse Events | Endophthalmitis in study eye | 0 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Ocular Adverse Events | Intraocular inflammation in study eye, total | 4 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Ocular Adverse Events | Serious Intraocular inflammation in study eye | 0 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Ocular Adverse Events | Any adverse event in fellow eye | 72 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Ocular Adverse Events | Adverse events led to discontinuation, fellow eye | 4 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Ocular Adverse Events | Endophthalmitis in fellow eye | 0 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Ocular Adverse Events | Intraocular inflammation in fellow eye, total | 0 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Ocular Adverse Events | Serious intraocular inflammation in fellow eye | 0 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Ocular Adverse Events | Serious Intraocular inflammation in study eye | 0 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Ocular Adverse Events | Intraocular inflammation in study eye, total | 1 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Ocular Adverse Events | Any adverse event in study eye | 59 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Ocular Adverse Events | Endophthalmitis in fellow eye | 0 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Ocular Adverse Events | Endophthalmitis in study eye | 0 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Ocular Adverse Events | Adverse events led to discontinuation, study eye | 2 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Ocular Adverse Events | Serious intraocular inflammation in fellow eye | 0 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Ocular Adverse Events | Intraocular inflammation in fellow eye, total | 0 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Ocular Adverse Events | Serious adverse events in fellow eye | 3 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Ocular Adverse Events | Any adverse event in fellow eye | 47 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Ocular Adverse Events | Serious adverse events in study eye | 2 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Ocular Adverse Events | Adverse events led to discontinuation, fellow eye | 3 participants |
Primary
Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24
Serum samples for the evaluation of antibodies to Ranibizumab were collected at Month 12 and Month 24 and were sent to a reference laboratory for analysis. If an injection of Ranibizumab was required at the visit, the samples were collected prior to the injection.
Time frame: Month 12 and 24
Population: Population included all enrolled participants treated with Ranibizumab in the extension study or in one of the initial studies. The number of participants for whom data was available at Month 12 and Month 24 are represented by n
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab Treated Initial Mono | Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24 | Month 12 (n=393,55,72,50) | 10 participants |
| Ranibizumab Treated Initial Mono | Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24 | Month 24 (n=316,45,78,42) | 9 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24 | Month 24 (n=316,45,78,42) | 0 participants |
| Ranibizumab Treated Initial + PDT | Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24 | Month 12 (n=393,55,72,50) | 0 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24 | Month 12 (n=393,55,72,50) | 1 participants |
| Ranibizumab Treated Sham XO | Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24 | Month 24 (n=316,45,78,42) | 1 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24 | Month 12 (n=393,55,72,50) | 0 participants |
| Ranibizumab Treated PDT XO | Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24 | Month 24 (n=316,45,78,42) | 0 participants |
Secondary
Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters
Change from baseline in Best corrected visual acuity (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: Extension study baseline, Months 12 and 24
Population: Enrolled participants. 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 Treated Initial Mono | Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters | Change from Baseline at Month 12 (n=446,133,35) | -5.4 letters | Standard Deviation 11.8 |
| Ranibizumab Treated Initial Mono | Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters | Change from Baseline at Month 24 (n=352,122,25) | -7.5 letters | Standard Deviation 12.3 |
| Ranibizumab Treated Initial + PDT | Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters | Change from Baseline at Month 24 (n=352,122,25) | -0.8 letters | Standard Deviation 13 |
| Ranibizumab Treated Initial + PDT | Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters | Change from Baseline at Month 12 (n=446,133,35) | -1.3 letters | Standard Deviation 11.8 |
| Ranibizumab Treated Sham XO | Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters | Change from Baseline at Month 12 (n=446,133,35) | -3.2 letters | Standard Deviation 7.2 |
| Ranibizumab Treated Sham XO | Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters | Change from Baseline at Month 24 (n=352,122,25) | -3.1 letters | Standard Deviation 8.2 |
| Ranibizumab Treated PDT XO | Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters | Change from Baseline at Month 12 (n=446,133,35) | -4.4 letters | Standard Deviation 11.7 |
| Ranibizumab Treated PDT XO | Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters | Change from Baseline at Month 24 (n=352,122,25) | -5.7 letters | Standard Deviation 12.7 |
Secondary
Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters
Change from baseline in Best corrected visual acuity (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 2 meters. An increase in the number of letters read indicates improvement in visual acuity.
Time frame: Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Population: Enrolled participants. 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 Treated Initial Mono | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 3 (n=284, 84, 25) | -2.9 letters | Standard Deviation 8.9 |
| Ranibizumab Treated Initial Mono | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 6 (n=519, 149, 46) | -3.4 letters | Standard Deviation 8.8 |
| Ranibizumab Treated Initial Mono | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 9 (n=490, 149, 38) | -4.4 letters | Standard Deviation 10.8 |
| Ranibizumab Treated Initial Mono | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 12 (n=481, 142, 38) | -5.2 letters | Standard Deviation 11.1 |
| Ranibizumab Treated Initial Mono | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 15 (n=447, 138, 31) | -5.6 letters | Standard Deviation 10.8 |
| Ranibizumab Treated Initial Mono | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 18 (n=420, 135, 28) | -6.4 letters | Standard Deviation 11.9 |
| Ranibizumab Treated Initial Mono | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 21 (n=405, 129, 28) | -7.9 letters | Standard Deviation 13 |
| Ranibizumab Treated Initial Mono | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 24 (n=388, 127, 27) | -8.1 letters | Standard Deviation 13 |
| Ranibizumab Treated Initial + PDT | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 18 (n=420, 135, 28) | -2.0 letters | Standard Deviation 12.5 |
| Ranibizumab Treated Initial + PDT | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 15 (n=447, 138, 31) | -2.2 letters | Standard Deviation 12.4 |
| Ranibizumab Treated Initial + PDT | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 6 (n=519, 149, 46) | -1.6 letters | Standard Deviation 10.5 |
| Ranibizumab Treated Initial + PDT | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 24 (n=388, 127, 27) | -2.0 letters | Standard Deviation 13.5 |
| Ranibizumab Treated Initial + PDT | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 21 (n=405, 129, 28) | -2.1 letters | Standard Deviation 13.3 |
| Ranibizumab Treated Initial + PDT | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 12 (n=481, 142, 38) | -2.3 letters | Standard Deviation 11.5 |
| Ranibizumab Treated Initial + PDT | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 9 (n=490, 149, 38) | -1.7 letters | Standard Deviation 11.3 |
| Ranibizumab Treated Initial + PDT | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 3 (n=284, 84, 25) | -2.9 letters | Standard Deviation 11 |
| Ranibizumab Treated Sham XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 21 (n=405, 129, 28) | -3.5 letters | Standard Deviation 10.8 |
| Ranibizumab Treated Sham XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 9 (n=490, 149, 38) | -2.2 letters | Standard Deviation 7.5 |
| Ranibizumab Treated Sham XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 12 (n=481, 142, 38) | -3.2 letters | Standard Deviation 8 |
| Ranibizumab Treated Sham XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 15 (n=447, 138, 31) | -3.0 letters | Standard Deviation 8.9 |
| Ranibizumab Treated Sham XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 18 (n=420, 135, 28) | -4.4 letters | Standard Deviation 9.5 |
| Ranibizumab Treated Sham XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 24 (n=388, 127, 27) | -2.9 letters | Standard Deviation 8.5 |
| Ranibizumab Treated Sham XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 3 (n=284, 84, 25) | 0.1 letters | Standard Deviation 6.6 |
| Ranibizumab Treated Sham XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 6 (n=519, 149, 46) | 0.3 letters | Standard Deviation 7 |
| Ranibizumab Treated PDT XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 9 (n=490, 149, 38) | -3.7 letters | Standard Deviation 10.8 |
| Ranibizumab Treated PDT XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 12 (n=481, 142, 38) | -4.5 letters | Standard Deviation 11.1 |
| Ranibizumab Treated PDT XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 6 (n=519, 149, 46) | -2.8 letters | Standard Deviation 9.1 |
| Ranibizumab Treated PDT XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 3 (n=284, 84, 25) | -2.7 letters | Standard Deviation 9.3 |
| Ranibizumab Treated PDT XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 15 (n=447, 138, 31) | -4.7 letters | Standard Deviation 11.2 |
| Ranibizumab Treated PDT XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 24 (n=388, 127, 27) | -6.4 letters | Standard Deviation 13.2 |
| Ranibizumab Treated PDT XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 21 (n=405, 129, 28) | -6.3 letters | Standard Deviation 13.2 |
| Ranibizumab Treated PDT XO | Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters | Change from Baseline at Month 18 (n=420, 135, 28) | -5.3 letters | Standard Deviation 12.1 |