Proliferative Diabetic Retinopathy (PDR)
Conditions
Keywords
Panretinal photocoagulation, Ranibizumab
Brief summary
The purpose of this study was to assess the efficacy and safety of the anti-Vascular Endothelial Growth Factor (VEGF) agent ranibizumab (0.5 mg) with or without Panretinal laser photocoagulation (PRP) compared to PRP alone in patients with Proliferative Diabetic Retinopathy (PDR).
Detailed description
A 12-month core phase was followed by a 12-month observational follow-up phase (physician's routine), for a planned individual study duration of 24-25 months. A separate informed consent was signed for the 12-month observational follow-up phase. This study was conducted in Germany.
Interventions
Pre-filled syringe for intravitreal injection
PROCEDUREPanretinal laser photocoagulation
PRP treatment following DRS guidelines
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
An open-label design was chosen in which the evaluation of the primary objective was performed by a reading center. The reading center that evaluated the primary and several secondary objectives was blinded to randomization and therefore assessed these objectives uninfluenced by treatment information. However, laser burns were visible on the images, and no full blinding regarding panretinal laser photocoagulation (PRP) was possible for the reading center.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Proliferative Diabetic Retinopathy * Best Corrected Visual Acuity (BCVA) in study eye of at least 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/400) * Type 1 or type 2 diabetes under medical surveillance / with stabilized treatment
Exclusion criteria
* Proliferative vitreoretinopathy in study eye * Clinically significant macular edema (CSME) in the study eye * Clinically non significant macular edema (CNSME) that is likely to develop to CSME in the study eye * Uncontrolled glaucoma in either eye * Other protocol-specified conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS) | Baseline, EOCS | The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS | EOCS | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. A higher number of ETDRS letters may indicate better visual acuity. One eye (study eye) contributed to the analysis. |
| Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | Baseline, EOCS | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. No clinically relevant change was defined as \<5 letters gain or loss. A higher positive change value may indicate a greater improvement in visual acuity. One eye (study eye) contributed to the analysis. |
| Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS | Baseline, EOCS | The severity level of diabetic retinopathy was determined using the ETDRS severity scale. However, in contrast to the original ETDRS severity scale, wide field fluorescein angiography images were used in addition to color fundus photography for identification of NVs and prior PRP treatment was not considered for determining the severity level. Eyes could be graded in the following classes: DR absent (10), questionable DR (14,15), NPDR (20-53), mild PDR (60-61), moderate PDR (65), high risk PDR (71-75), advanced PDR (81-85) and cannot grade (90). One eye (study eye) contributed to the analysis. No statistical analysis was conducted for ≥ 1 class deterioration or ≥ 2 class deterioration from Baseline at EOCS because ratios could not be calculated in case of zero frequencies in at least one of the three treatment groups. |
| Change From Baseline in Area of Neovascularizations (NVs) at Month 3 | Baseline, Month 3 | The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis. |
| Change From Baseline in Foveal Center Point Retinal Thickness at EOCS | Baseline, EOCS | Foveal center point retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis. |
| Number of Ranibizumab Injections Until EOCS | Baseline to EOCS | The total number of ranibizumab injections until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted. |
| Number of PRP Laser Spots Until EOCS | Baseline to EOCS | The total number of PRP laser spots from baseline until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted. |
| Change From Baseline in Central Subfield Thickness at EOCS | Baseline, EOCS | Central subfield retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis. |
Countries
Germany
Participant flow
Recruitment details
Patients were screened for eligibility at 23 German study sites and randomized at 22 of the 23 sites.
Pre-assignment details
The number of patients in the protocol section (107) excludes one patient in the Ranibizumab mono arm who withdrew prior to the baseline visit. The number of patients in the Randomized Set (108) includes this patient. A separate Informed Consent was signed for the Non-Interventional Follow Up Phase
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab Mono Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24 | 35 |
| PRP Mono Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures. If stability of morphological parameters could not be confirmed after 3 months, additional laser treatment was initiated.
Non-Interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24. | 35 |
| Ranibizumab+PRP Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24 | 36 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Interventional Core Phase | Adverse Event | 4 | 4 | 4 |
| Interventional Core Phase | Death | 1 | 1 | 2 |
| Interventional Core Phase | Lost to Follow-up | 1 | 4 | 1 |
| Interventional Core Phase | Protocol Deviation | 1 | 0 | 0 |
| Interventional Core Phase | Subject Withdrew Consent | 0 | 1 | 1 |
| Non-Interventional Follow Up Phase | Administrative Problems | 0 | 0 | 1 |
| Non-Interventional Follow Up Phase | Lost to Follow-up | 2 | 2 | 0 |
| Non-Interventional Follow Up Phase | Subject Withdrew Consent | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Ranibizumab Mono | PRP Mono | Ranibizumab+PRP | Total |
|---|---|---|---|---|
| Age, Continuous | 52.5 Years STANDARD_DEVIATION 11 | 53.0 Years STANDARD_DEVIATION 12.1 | 55.0 Years STANDARD_DEVIATION 13.4 | 53.5 Years STANDARD_DEVIATION 12.1 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 14 Participants | 11 Participants | 8 Participants | 33 Participants |
| Sex: Female, Male Male | 21 Participants | 24 Participants | 28 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 35 | 1 / 35 | 2 / 36 | 0 / 28 | 0 / 20 | 0 / 25 |
| other Total, other adverse events | 34 / 35 | 29 / 35 | 34 / 36 | 21 / 28 | 12 / 20 | 21 / 25 |
| serious Total, serious adverse events | 8 / 35 | 11 / 35 | 16 / 36 | 5 / 28 | 5 / 20 | 11 / 25 |
Outcome results
Primary
Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS)
The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis.
Time frame: Baseline, EOCS
Population: FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab Mono | Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS) | -4.6 square millimeters | Standard Deviation 11.3 |
| PRP Mono | Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS) | -0.9 square millimeters | Standard Deviation 3.9 |
| Ranibizumab+PRP | Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS) | -1.7 square millimeters | Standard Deviation 3 |
p-value: 0.034495% CI: [-5.4, -0.2]ANCOVA
p-value: 0.380995% CI: [-3.8, 1.5]ANCOVA
p-value: 0.211395% CI: [-1, 4.3]ANCOVA
Secondary
Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. A higher number of ETDRS letters may indicate better visual acuity. One eye (study eye) contributed to the analysis.
Time frame: EOCS
Population: FAS; LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab Mono | Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS | 84.4 letters | Standard Deviation 8.6 |
| PRP Mono | Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS | 76.8 letters | Standard Deviation 17 |
| Ranibizumab+PRP | Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS | 78.9 letters | Standard Deviation 12.2 |
p-value: 0.049595% CI: [0, 11]ANCOVA
p-value: 0.276795% CI: [-2.5, 8.5]ANCOVA
p-value: 0.364195% CI: [-7.9, 2.9]ANCOVA
Secondary
Change From Baseline in Area of Neovascularizations (NVs) at Month 3
The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Month 3
Population: FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab Mono | Change From Baseline in Area of Neovascularizations (NVs) at Month 3 | -5.9 square millimeters | Standard Deviation 12.7 |
| PRP Mono | Change From Baseline in Area of Neovascularizations (NVs) at Month 3 | -0.7 square millimeters | Standard Deviation 2.8 |
| Ranibizumab+PRP | Change From Baseline in Area of Neovascularizations (NVs) at Month 3 | -2.7 square millimeters | Standard Deviation 3.9 |
p-value: 0.008195% CI: [-4.2, -0.6]ANCOVA
p-value: 0.749495% CI: [-2, 1.5]ANCOVA
p-value: 0.017595% CI: [0.4, 3.9]ANCOVA
Secondary
Change From Baseline in Central Subfield Thickness at EOCS
Central subfield retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis.
Time frame: Baseline, EOCS
Population: FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab Mono | Change From Baseline in Central Subfield Thickness at EOCS | -6.0 micrometer | Standard Deviation 15.1 |
| PRP Mono | Change From Baseline in Central Subfield Thickness at EOCS | 36.2 micrometer | Standard Deviation 55.9 |
| Ranibizumab+PRP | Change From Baseline in Central Subfield Thickness at EOCS | 17.6 micrometer | Standard Deviation 46.7 |
p-value: 0.000395% CI: [-62.1, -19.3]ANCOVA
p-value: 0.035795% CI: [-44.2, -1.6]ANCOVA
p-value: 0.103495% CI: [-3.7, 39.3]ANCOVA
Secondary
Change From Baseline in Foveal Center Point Retinal Thickness at EOCS
Foveal center point retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis.
Time frame: Baseline, EOCS
Population: FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab Mono | Change From Baseline in Foveal Center Point Retinal Thickness at EOCS | -4.7 micrometer | Standard Deviation 21.2 |
| PRP Mono | Change From Baseline in Foveal Center Point Retinal Thickness at EOCS | 48.1 micrometer | Standard Deviation 83.7 |
| Ranibizumab+PRP | Change From Baseline in Foveal Center Point Retinal Thickness at EOCS | 25.5 micrometer | Standard Deviation 53.5 |
p-value: 0.000795% CI: [-81.1, -22.3]ANCOVA
p-value: 0.054295% CI: [-58.4, 0.5]ANCOVA
p-value: 0.128895% CI: [-6.7, 52.3]ANCOVA
Secondary
Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS
The severity level of diabetic retinopathy was determined using the ETDRS severity scale. However, in contrast to the original ETDRS severity scale, wide field fluorescein angiography images were used in addition to color fundus photography for identification of NVs and prior PRP treatment was not considered for determining the severity level. Eyes could be graded in the following classes: DR absent (10), questionable DR (14,15), NPDR (20-53), mild PDR (60-61), moderate PDR (65), high risk PDR (71-75), advanced PDR (81-85) and cannot grade (90). One eye (study eye) contributed to the analysis. No statistical analysis was conducted for ≥ 1 class deterioration or ≥ 2 class deterioration from Baseline at EOCS because ratios could not be calculated in case of zero frequencies in at least one of the three treatment groups.
Time frame: Baseline, EOCS
Population: FAS. Only patients with both values at baseline and any post-baseline value were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab Mono | Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS | ≥ 2 class improvement from Baseline at EOCS | 2 participants |
| Ranibizumab Mono | Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS | ≥ 1 class improvement from Baseline at EOCS | 10 participants |
| Ranibizumab Mono | Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS | ≥ 1 class deterioration from Baseline at EOCS | 2 participants |
| Ranibizumab Mono | Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS | ≥ 2 class deterioration from Baseline at EOCS | 0 participants |
| PRP Mono | Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS | ≥ 2 class deterioration from Baseline at EOCS | 0 participants |
| PRP Mono | Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS | ≥ 1 class deterioration from Baseline at EOCS | 0 participants |
| PRP Mono | Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS | ≥ 1 class improvement from Baseline at EOCS | 9 participants |
| PRP Mono | Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS | ≥ 2 class improvement from Baseline at EOCS | 2 participants |
| Ranibizumab+PRP | Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS | ≥ 1 class improvement from Baseline at EOCS | 13 participants |
| Ranibizumab+PRP | Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS | ≥ 2 class improvement from Baseline at EOCS | 5 participants |
| Ranibizumab+PRP | Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS | ≥ 1 class deterioration from Baseline at EOCS | 1 participants |
| Ranibizumab+PRP | Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS | ≥ 2 class deterioration from Baseline at EOCS | 0 participants |
Comparison: ≥ 1 class improvement from Baseline at EOCSp-value: 0.991895% CI: [0.327, 3.026]Regression, Logistic
Comparison: ≥ 1 class improvement from Baseline at EOCSp-value: 0.359595% CI: [0.209, 1.765]Regression, Logistic
Comparison: ≥ 1 class improvement from Baseline at EOCSp-value: 0.378795% CI: [0.204, 1.83]Regression, Logistic
Comparison: ≥ 2 class improvement from Baseline at EOCSp-value: 0.909795% CI: [0.116, 6.806]Regression, Logistic
Comparison: ≥ 2 class improvement from Baseline at EOCSp-value: 0.22395% CI: [0.06, 1.925]Regression, Logistic
Comparison: ≥ 2 class improvement from Baseline at EOCSp-value: 0.279295% CI: [0.068, 2.177]Regression, Logistic
Secondary
Number of PRP Laser Spots Until EOCS
The total number of PRP laser spots from baseline until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Time frame: Baseline to EOCS
Population: Safety Set. Only patients with at least 1 laser therapy until EOCS are included in the analysis. This outcome measure was pre-specified for the PRP and the ranibizumab+PRP arms only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab Mono | Number of PRP Laser Spots Until EOCS | NA PRP laser spots | — |
| PRP Mono | Number of PRP Laser Spots Until EOCS | 1919.4 PRP laser spots | Standard Deviation 673.1 |
| Ranibizumab+PRP | Number of PRP Laser Spots Until EOCS | 1670.0 PRP laser spots | Standard Deviation 568.4 |
Secondary
Number of Ranibizumab Injections Until EOCS
The total number of ranibizumab injections until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Time frame: Baseline to EOCS
Population: Safety Set. This outcome measure was pre-specified for the ranibizumab mono and ranibizumab+PRP arms only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab Mono | Number of Ranibizumab Injections Until EOCS | 5.2 injections | Standard Deviation 2.3 |
| PRP Mono | Number of Ranibizumab Injections Until EOCS | NA injections | — |
| Ranibizumab+PRP | Number of Ranibizumab Injections Until EOCS | 5.0 injections | Standard Deviation 2.2 |
Secondary
Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. No clinically relevant change was defined as \<5 letters gain or loss. A higher positive change value may indicate a greater improvement in visual acuity. One eye (study eye) contributed to the analysis.
Time frame: Baseline, EOCS
Population: FAS; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab Mono | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥10 letters loss from Baseline at EOCS | 11.4 percentage of participants |
| Ranibizumab Mono | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥5 letters gain from Baseline at EOCS | 31.4 percentage of participants |
| Ranibizumab Mono | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥5 letters loss from Baseline at EOCS | 17.1 percentage of participants |
| Ranibizumab Mono | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | No clinically relevant change from Baseline | 51.4 percentage of participants |
| Ranibizumab Mono | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥15 letters loss from Baseline at EOCS | 2.9 percentage of participants |
| Ranibizumab Mono | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥10 letters gain from Baseline at EOCS | 5.7 percentage of participants |
| Ranibizumab Mono | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥15 letters gain from Baseline at EOCS | 0.0 percentage of participants |
| PRP Mono | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥5 letters gain from Baseline at EOCS | 20.0 percentage of participants |
| PRP Mono | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥15 letters loss from Baseline at EOCS | 8.6 percentage of participants |
| PRP Mono | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥15 letters gain from Baseline at EOCS | 2.9 percentage of participants |
| PRP Mono | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥10 letters gain from Baseline at EOCS | 11.4 percentage of participants |
| PRP Mono | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | No clinically relevant change from Baseline | 42.9 percentage of participants |
| PRP Mono | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥5 letters loss from Baseline at EOCS | 37.1 percentage of participants |
| PRP Mono | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥10 letters loss from Baseline at EOCS | 11.4 percentage of participants |
| Ranibizumab+PRP | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥15 letters gain from Baseline at EOCS | 0.0 percentage of participants |
| Ranibizumab+PRP | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥5 letters loss from Baseline at EOCS | 25.0 percentage of participants |
| Ranibizumab+PRP | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥10 letters gain from Baseline at EOCS | 8.3 percentage of participants |
| Ranibizumab+PRP | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥15 letters loss from Baseline at EOCS | 2.8 percentage of participants |
| Ranibizumab+PRP | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥10 letters loss from Baseline at EOCS | 8.3 percentage of participants |
| Ranibizumab+PRP | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | No clinically relevant change from Baseline | 61.1 percentage of participants |
| Ranibizumab+PRP | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | ≥5 letters gain from Baseline at EOCS | 13.9 percentage of participants |
Comparison: ≥5 letters lossp-value: 0.27195% CI: [0.64, 4.913]Regression, Logistic
Comparison: ≥10 letters lossp-value: 0.663295% CI: [0.294, 6.856]Regression, Logistic
Comparison: ≥10 letters gainp-value: 0.401995% CI: [0.08, 2.749]Regression, Logistic
Comparison: ≥5 letters gainp-value: 0.277295% CI: [0.614, 5.471]Regression, Logistic
Comparison: No clinically relevant changep-value: 0.473195% CI: [0.55, 3.622]Regression, Logistic
Comparison: ≥5 letters lossp-value: 0.06595% CI: [0.155, 1.068]Regression, Logistic
Comparison: ≥10 letters lossp-value: 195% CI: [0.229, 4.361]Regression, Logistic
Comparison: ≥15 letters lossp-value: 0.326195% CI: [0.031, 3.173]Regression, Logistic
Comparison: ≥10 letters gainp-value: 0.66895% CI: [0.104, 4.253]Regression, Logistic
Comparison: ≥5 letters gainp-value: 0.083895% CI: [0.87, 9.283]Regression, Logistic
Comparison: No clinically relevant changep-value: 0.411695% CI: [0.263, 1.729]Regression, Logistic
Comparison: ≥5 letters lossp-value: 0.419795% CI: [0.195, 1.977]Regression, Logistic
Comparison: ≥10 letters lossp-value: 0.663295% CI: [0.294, 6.856]Regression, Logistic
Comparison: ≥15 letters lossp-value: 0.983995% CI: [0.062, 17.127]Regression, Logistic
Comparison: ≥10 letters gainp-value: 0.66395% CI: [0.294, 6.858]Regression, Logistic
Comparison: ≥5 letters gainp-value: 0.494195% CI: [0.441, 5.444]Regression, Logistic
Comparison: No clinically relevant changep-value: 0.125995% CI: [0.185, 1.231]Regression, Logistic
Comparison: ≥15 letters lossp-value: 0.31495% CI: [0.325, 33.171]Regression, Logistic