Age Related Macular Degeneration
Conditions
Keywords
bevacizumab, ranibizumab, choroidal neovascularization
Brief summary
The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule. A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.
Detailed description
Age related macular degeneration (AMD) is the leading cause of severe vision loss in people over the age of 65 in the United States and other Western countries. More than 1.6 million people in the US currently have one or both eyes affected by the advanced stage of AMD. Lucentis® is the most effective treatment for neovascular AMD studied to date. Bevacizumab (Avastin®) and Lucentis® are derived from the same monoclonal antibody. Following the encouraging clinical trial results with Lucentis®, several investigators began evaluating intravitreal Avastin® for the treatment of CNV. Given its molecular similarity to Lucentis, its low cost, and its availability, the interest in Avastin® has been considerable. Avastin® has not been evaluated relative to Lucentis®. In addition, previous studies do not answer the question of whether a reduced dosing schedule is as effective as a fixed schedule of monthly injections. Treatment dependent on clinical response has the potential to reduce the treatment burden to patients as well as to reduce the overall cost of therapy. Only a single eye in each patient was analyzed. At the five year follow-up visit, the subjects will undergo the same examinations and procedures as in the original study; however, the five year follow-up visit deos not involve any study treatment.
Interventions
DRUGranibizumab
• 0.5 mg (0.05 mL)intravitreal injection
DRUGbevacizumab
• 1.25 mg (0.05 mL)intravitreal injection
Sponsors
National Eye Institute (NEI)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Active, subfoveal choroidal neovascularization (CNV) * Fibrosis \< 50% of total lesion area * Visual acuity (VA) 20/25-20/320 * Age ≥ 50 yrs * At least 1 drusen (\>63μ) in either eye or late AMD in fellow eye
Exclusion criteria
* Previous treatment for CNV in study eye * Other progressive retinal disease likely to compromise VA * Contraindications to injections with Lucentis or Avastin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Visual-acuity Score (Continuous) | Baseline and 1 Year | Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. The VA score change is the difference of the VA score at 1 Year and the VA score at baseline. In this study, the outcome VA score change is ranged from -71 to 52, with the higher VA score change the better visual acuity improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual-acuity Score and Snellen Equivalent (Frequency) | at 1 Year | — |
| Visual-acuity Score and Snellen Equivalent (Continuous) | at 1 Year | Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. In this study, the outcome VA score is ranged from 0 to 97, with the higher score the better visual acuity. |
| Number of Treatments | 1 Year | Cumulative over the 1 year of trial |
| Average Cost of Drug/Patient | at 1 Year | — |
| Total Thickness at Fovea | at 1 Year | — |
| Total Thickness Change From Baseline at Fovea | Baseline and 1 Year | — |
| Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea | at 1 Year | — |
| Change From Baseline Visual-acuity Score (Frequency) | Baseline and 1 Year | — |
| Fluid on Optical Coherence Tomography | at 1 Year | — |
| Dye Leakage on Angiogram | at 1 Year | — |
| Area of Lesion | at 1 Year | — |
| Area of Lesion Change From Baseline | Baseline and 1 Year | — |
| Change in Systolic Blood Pressure From Baseline | Baseline and 1 Year | — |
| Change in Diastolic Blood Pressure From Baseline | Baseline and 1 Year | — |
| Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea | Baseline and 1 Year | — |
Countries
United States
Participant flow
Pre-assignment details
Note: The Data and Safety Monitoring Committee for CATT recommended excluding the data for all patients (N=23) from one center because of serious protocol non-compliance. Unless specified otherwise, only the 1185 patients enrolled by the remaining 43 centers are included in analyses.
Participants by arm
| Arm | Count |
|---|---|
| 1-Lucentis Monthly Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing. | 301 |
| 2-Avastin Monthly Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing. | 286 |
| 3-Lucentis as Needed Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity. | 298 |
| 4-Avastin as Needed Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity. | 300 |
| Total | 1,185 |
Baseline characteristics
| Characteristic | 1-Lucentis Monthly | 2-Avastin Monthly | 3-Lucentis as Needed | 4-Avastin as Needed | Total |
|---|---|---|---|---|---|
| Age, Continuous | 79.2 years STANDARD_DEVIATION 7.4 | 80.1 years STANDARD_DEVIATION 7.3 | 78.4 years STANDARD_DEVIATION 7.8 | 79.3 years STANDARD_DEVIATION 7.6 | 79.3 years STANDARD_DEVIATION 7.5 |
| Age, Customized 50-59 years | 2 participants | 1 participants | 6 participants | 2 participants | 11 participants |
| Age, Customized 60-69 years | 33 participants | 28 participants | 31 participants | 34 participants | 126 participants |
| Age, Customized 70-79 years | 102 participants | 84 participants | 115 participants | 103 participants | 404 participants |
| Age, Customized 80-89 years | 142 participants | 150 participants | 126 participants | 142 participants | 560 participants |
| Age, Customized >=90 years | 22 participants | 23 participants | 20 participants | 19 participants | 84 participants |
| Diastolic blood pressure | 75 mm Hg STANDARD_DEVIATION 10 | 75 mm Hg STANDARD_DEVIATION 10 | 76 mm Hg STANDARD_DEVIATION 9 | 75 mm Hg STANDARD_DEVIATION 10 | 75 mm Hg STANDARD_DEVIATION 10 |
| Foveal center involvement Choroidal neovacularization | 176 Participants | 153 Participants | 176 Participants | 183 Participants | 688 Participants |
| Foveal center involvement Fluid | 85 Participants | 81 Participants | 77 Participants | 72 Participants | 315 Participants |
| Foveal center involvement Hemorrhage | 20 Participants | 24 Participants | 24 Participants | 25 Participants | 93 Participants |
| Foveal center involvement No choroidal neovascularization or can't grade | 2 Participants | 8 Participants | 6 Participants | 2 Participants | 18 Participants |
| Foveal center involvement Other | 18 Participants | 20 Participants | 15 Participants | 18 Participants | 71 Participants |
| History of myocardial infarction No | 267 Participants | 246 Participants | 268 Participants | 264 Participants | 1045 Participants |
| History of myocardial infarction Yes | 34 Participants | 40 Participants | 30 Participants | 36 Participants | 140 Participants |
| History of stroke No | 287 Participants | 268 Participants | 276 Participants | 284 Participants | 1115 Participants |
| History of stroke Yes | 14 Participants | 18 Participants | 22 Participants | 16 Participants | 70 Participants |
| History of transient ischemic attack No | 289 Participants | 261 Participants | 286 Participants | 281 Participants | 1117 Participants |
| History of transient ischemic attack Yes | 12 Participants | 25 Participants | 12 Participants | 19 Participants | 68 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 5 Participants | 2 Participants | 6 Participants | 17 Participants |
| Race/Ethnicity, Customized White | 297 Participants | 281 Participants | 296 Participants | 294 Participants | 1168 Participants |
| Retinal thickness plus subfoveal-fluid thickness at fovea | 251 microns STANDARD_DEVIATION 122 | 254 microns STANDARD_DEVIATION 121 | 247 microns STANDARD_DEVIATION 122 | 252 microns STANDARD_DEVIATION 115 | 251 microns STANDARD_DEVIATION 120 |
| Sex: Female, Male Female | 183 Participants | 180 Participants | 185 Participants | 184 Participants | 732 Participants |
| Sex: Female, Male Male | 118 Participants | 106 Participants | 113 Participants | 116 Participants | 453 Participants |
| Systolic blood pressure | 134 mm Hg STANDARD_DEVIATION 18 | 135 mm Hg STANDARD_DEVIATION 19 | 136 mm Hg STANDARD_DEVIATION 17 | 135 mm Hg STANDARD_DEVIATION 17 | 135 mm Hg STANDARD_DEVIATION 18 |
| Total thickness at fovea | 458 μm STANDARD_DEVIATION 184 | 463 μm STANDARD_DEVIATION 196 | 458 μm STANDARD_DEVIATION 193 | 461 μm STANDARD_DEVIATION 175 | 460 μm STANDARD_DEVIATION 187 |
| Visual-acuity score and Snellen equivalent 23-37 letters, 20/200-320 | 25 Participants | 21 Participants | 16 Participants | 20 Participants | 82 Participants |
| Visual-acuity score and Snellen equivalent 38-52 letters, 20/100-160 | 67 Participants | 53 Participants | 58 Participants | 58 Participants | 236 Participants |
| Visual-acuity score and Snellen equivalent 53-67 letters, 20/50-80 | 98 Participants | 118 Participants | 108 Participants | 119 Participants | 443 Participants |
| Visual-acuity score and Snellen equivalent 68-82 letters, 20/25-40 | 111 Participants | 94 Participants | 116 Participants | 103 Participants | 424 Participants |
| Visual-acuity score and Snellen equivalent | 60.1 Letters STANDARD_DEVIATION 14.3 | 60.2 Letters STANDARD_DEVIATION 13.1 | 61.5 Letters STANDARD_DEVIATION 13.2 | 60.4 Letters STANDARD_DEVIATION 13.4 | 60.5 Letters STANDARD_DEVIATION 13.5 |
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 | 3 / 301 | 4 / 286 | 0 / 298 | 0 / 300 |
| serious Total, serious adverse events | 53 / 301 | 64 / 286 | 61 / 298 | 77 / 300 |
Outcome results
Primary
Change From Baseline in Visual-acuity Score (Continuous)
Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. The VA score change is the difference of the VA score at 1 Year and the VA score at baseline. In this study, the outcome VA score change is ranged from -71 to 52, with the higher VA score change the better visual acuity improvement.
Time frame: Baseline and 1 Year
Population: All patients who had VA measured at week 52 were included in the analysis. All analyses were performed on the basis of the intention-to-treat principle. The Data and Safety Monitoring Committee recommended that data for all 23 patients at one center be excluded because of serious protocol noncompliance.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-Lucentis Monthly | Change From Baseline in Visual-acuity Score (Continuous) | 8.5 No. of Letters | Standard Deviation 14.1 |
| 2-Avastin Monthly | Change From Baseline in Visual-acuity Score (Continuous) | 8.0 No. of Letters | Standard Deviation 15.8 |
| 3-Lucentis as Needed | Change From Baseline in Visual-acuity Score (Continuous) | 6.8 No. of Letters | Standard Deviation 13.1 |
| 4-Avastin as Needed | Change From Baseline in Visual-acuity Score (Continuous) | 5.9 No. of Letters | Standard Deviation 15.7 |
Comparison: The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.p-value: 0.1699.2% CI: [-3.9, 2.9]ANOVA
Comparison: The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.p-value: 0.1699.2% CI: [-4.1, 2.4]ANOVA
Comparison: The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.p-value: 0.1699.2% CI: [-4.7, 1.3]ANOVA
Comparison: The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.p-value: 0.1699.2% CI: [-5.7, 1.6]ANOVA
Comparison: The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.p-value: 0.1699.2% CI: [-4.5, 2.1]ANOVA
Comparison: The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.p-value: 0.1699.2% CI: [-5.9, 0.8]ANOVA
Secondary
Area of Lesion
Time frame: at 1 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-Lucentis Monthly | Area of Lesion | 6.6 mm^2 | Standard Deviation 6.8 |
| 2-Avastin Monthly | Area of Lesion | 6.5 mm^2 | Standard Deviation 6.7 |
| 3-Lucentis as Needed | Area of Lesion | 7.3 mm^2 | Standard Deviation 6.5 |
| 4-Avastin as Needed | Area of Lesion | 7.0 mm^2 | Standard Deviation 7.5 |
Secondary
Area of Lesion Change From Baseline
Time frame: Baseline and 1 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-Lucentis Monthly | Area of Lesion Change From Baseline | -0.1 mm^2 | Standard Deviation 5.2 |
| 2-Avastin Monthly | Area of Lesion Change From Baseline | 0.3 mm^2 | Standard Deviation 4.9 |
| 3-Lucentis as Needed | Area of Lesion Change From Baseline | 0.6 mm^2 | Standard Deviation 6.2 |
| 4-Avastin as Needed | Area of Lesion Change From Baseline | 1.3 mm^2 | Standard Deviation 6.6 |
Secondary
Average Cost of Drug/Patient
Time frame: at 1 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-Lucentis Monthly | Average Cost of Drug/Patient | 23400 US dollars per patient | Standard Deviation 3000 |
| 2-Avastin Monthly | Average Cost of Drug/Patient | 595 US dollars per patient | Standard Deviation 60 |
| 3-Lucentis as Needed | Average Cost of Drug/Patient | 13800 US dollars per patient | Standard Deviation 6000 |
| 4-Avastin as Needed | Average Cost of Drug/Patient | 385 US dollars per patient | Standard Deviation 175 |
Secondary
Change From Baseline Visual-acuity Score (Frequency)
Time frame: Baseline and 1 Year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1-Lucentis Monthly | Change From Baseline Visual-acuity Score (Frequency) | Increase of 5-14 letters | 90 Participants |
| 1-Lucentis Monthly | Change From Baseline Visual-acuity Score (Frequency) | Decrease of 5-14 letters | 19 Participants |
| 1-Lucentis Monthly | Change From Baseline Visual-acuity Score (Frequency) | Decrease of ≥15 letters | 16 Participants |
| 1-Lucentis Monthly | Change From Baseline Visual-acuity Score (Frequency) | Increase of ≥15 letters | 97 Participants |
| 1-Lucentis Monthly | Change From Baseline Visual-acuity Score (Frequency) | Change of ≤4 letters | 62 Participants |
| 2-Avastin Monthly | Change From Baseline Visual-acuity Score (Frequency) | Change of ≤4 letters | 50 Participants |
| 2-Avastin Monthly | Change From Baseline Visual-acuity Score (Frequency) | Decrease of 5-14 letters | 18 Participants |
| 2-Avastin Monthly | Change From Baseline Visual-acuity Score (Frequency) | Increase of ≥15 letters | 83 Participants |
| 2-Avastin Monthly | Change From Baseline Visual-acuity Score (Frequency) | Increase of 5-14 letters | 98 Participants |
| 2-Avastin Monthly | Change From Baseline Visual-acuity Score (Frequency) | Decrease of ≥15 letters | 16 Participants |
| 3-Lucentis as Needed | Change From Baseline Visual-acuity Score (Frequency) | Change of ≤4 letters | 75 Participants |
| 3-Lucentis as Needed | Change From Baseline Visual-acuity Score (Frequency) | Increase of ≥15 letters | 71 Participants |
| 3-Lucentis as Needed | Change From Baseline Visual-acuity Score (Frequency) | Increase of 5-14 letters | 103 Participants |
| 3-Lucentis as Needed | Change From Baseline Visual-acuity Score (Frequency) | Decrease of 5-14 letters | 23 Participants |
| 3-Lucentis as Needed | Change From Baseline Visual-acuity Score (Frequency) | Decrease of ≥15 letters | 13 Participants |
| 4-Avastin as Needed | Change From Baseline Visual-acuity Score (Frequency) | Decrease of 5-14 letters | 23 Participants |
| 4-Avastin as Needed | Change From Baseline Visual-acuity Score (Frequency) | Increase of ≥15 letters | 76 Participants |
| 4-Avastin as Needed | Change From Baseline Visual-acuity Score (Frequency) | Increase of 5-14 letters | 90 Participants |
| 4-Avastin as Needed | Change From Baseline Visual-acuity Score (Frequency) | Change of ≤4 letters | 59 Participants |
| 4-Avastin as Needed | Change From Baseline Visual-acuity Score (Frequency) | Decrease of ≥15 letters | 23 Participants |
Secondary
Change in Diastolic Blood Pressure From Baseline
Time frame: Baseline and 1 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-Lucentis Monthly | Change in Diastolic Blood Pressure From Baseline | -0.9 mm Hg | Standard Deviation 11.9 |
| 2-Avastin Monthly | Change in Diastolic Blood Pressure From Baseline | -1.4 mm Hg | Standard Deviation 11.2 |
| 3-Lucentis as Needed | Change in Diastolic Blood Pressure From Baseline | -1.9 mm Hg | Standard Deviation 10.2 |
| 4-Avastin as Needed | Change in Diastolic Blood Pressure From Baseline | -2.1 mm Hg | Standard Deviation 10.8 |
Secondary
Change in Systolic Blood Pressure From Baseline
Time frame: Baseline and 1 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-Lucentis Monthly | Change in Systolic Blood Pressure From Baseline | -2.1 mm Hg | Standard Deviation 22.4 |
| 2-Avastin Monthly | Change in Systolic Blood Pressure From Baseline | -5.4 mm Hg | Standard Deviation 18.2 |
| 3-Lucentis as Needed | Change in Systolic Blood Pressure From Baseline | -5.2 mm Hg | Standard Deviation 20.3 |
| 4-Avastin as Needed | Change in Systolic Blood Pressure From Baseline | -4.5 mm Hg | Standard Deviation 20 |
Secondary
Dye Leakage on Angiogram
Time frame: at 1 Year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1-Lucentis Monthly | Dye Leakage on Angiogram | Absent | 167 Participants |
| 1-Lucentis Monthly | Dye Leakage on Angiogram | Data missing | 20 Participants |
| 1-Lucentis Monthly | Dye Leakage on Angiogram | Present | 97 Participants |
| 2-Avastin Monthly | Dye Leakage on Angiogram | Absent | 153 Participants |
| 2-Avastin Monthly | Dye Leakage on Angiogram | Data missing | 12 Participants |
| 2-Avastin Monthly | Dye Leakage on Angiogram | Present | 100 Participants |
| 3-Lucentis as Needed | Dye Leakage on Angiogram | Present | 137 Participants |
| 3-Lucentis as Needed | Dye Leakage on Angiogram | Absent | 133 Participants |
| 3-Lucentis as Needed | Dye Leakage on Angiogram | Data missing | 15 Participants |
| 4-Avastin as Needed | Dye Leakage on Angiogram | Absent | 111 Participants |
| 4-Avastin as Needed | Dye Leakage on Angiogram | Data missing | 15 Participants |
| 4-Avastin as Needed | Dye Leakage on Angiogram | Present | 145 Participants |
Secondary
Fluid on Optical Coherence Tomography
Time frame: at 1 Year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1-Lucentis Monthly | Fluid on Optical Coherence Tomography | Absent | 124 Participants |
| 1-Lucentis Monthly | Fluid on Optical Coherence Tomography | Data missing | 9 Participants |
| 1-Lucentis Monthly | Fluid on Optical Coherence Tomography | Present | 151 Participants |
| 2-Avastin Monthly | Fluid on Optical Coherence Tomography | Absent | 69 Participants |
| 2-Avastin Monthly | Fluid on Optical Coherence Tomography | Data missing | 8 Participants |
| 2-Avastin Monthly | Fluid on Optical Coherence Tomography | Present | 188 Participants |
| 3-Lucentis as Needed | Fluid on Optical Coherence Tomography | Present | 203 Participants |
| 3-Lucentis as Needed | Fluid on Optical Coherence Tomography | Absent | 68 Participants |
| 3-Lucentis as Needed | Fluid on Optical Coherence Tomography | Data missing | 14 Participants |
| 4-Avastin as Needed | Fluid on Optical Coherence Tomography | Absent | 52 Participants |
| 4-Avastin as Needed | Fluid on Optical Coherence Tomography | Data missing | 5 Participants |
| 4-Avastin as Needed | Fluid on Optical Coherence Tomography | Present | 214 Participants |
Secondary
Number of Treatments
Cumulative over the 1 year of trial
Time frame: 1 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-Lucentis Monthly | Number of Treatments | 11.7 Number of Treatments | Standard Error 1.5 |
| 2-Avastin Monthly | Number of Treatments | 11.9 Number of Treatments | Standard Error 1.2 |
| 3-Lucentis as Needed | Number of Treatments | 6.9 Number of Treatments | Standard Error 3 |
| 4-Avastin as Needed | Number of Treatments | 7.7 Number of Treatments | Standard Error 3.5 |
Secondary
Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea
Time frame: at 1 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-Lucentis Monthly | Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea | 152 μm | Standard Deviation 57 |
| 2-Avastin Monthly | Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea | 172 μm | Standard Deviation 81 |
| 3-Lucentis as Needed | Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea | 166 μm | Standard Deviation 66 |
| 4-Avastin as Needed | Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea | 172 μm | Standard Deviation 68 |
Secondary
Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea
Time frame: Baseline and 1 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-Lucentis Monthly | Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea | -100 μm | Standard Deviation 130 |
| 2-Avastin Monthly | Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea | -79 μm | Standard Deviation 132 |
| 3-Lucentis as Needed | Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea | -81 μm | Standard Deviation 134 |
| 4-Avastin as Needed | Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea | -79 μm | Standard Deviation 123 |
Secondary
Total Thickness at Fovea
Time frame: at 1 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-Lucentis Monthly | Total Thickness at Fovea | 266 μm | Standard Deviation 125 |
| 2-Avastin Monthly | Total Thickness at Fovea | 300 μm | Standard Deviation 149 |
| 3-Lucentis as Needed | Total Thickness at Fovea | 294 μm | Standard Deviation 139 |
| 4-Avastin as Needed | Total Thickness at Fovea | 308 μm | Standard Deviation 127 |
Secondary
Total Thickness Change From Baseline at Fovea
Time frame: Baseline and 1 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-Lucentis Monthly | Total Thickness Change From Baseline at Fovea | -196 μm | Standard Deviation 176 |
| 2-Avastin Monthly | Total Thickness Change From Baseline at Fovea | -164 μm | Standard Deviation 181 |
| 3-Lucentis as Needed | Total Thickness Change From Baseline at Fovea | -168 μm | Standard Deviation 186 |
| 4-Avastin as Needed | Total Thickness Change From Baseline at Fovea | -152 μm | Standard Deviation 178 |
Secondary
Visual-acuity Score and Snellen Equivalent (Continuous)
Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. In this study, the outcome VA score is ranged from 0 to 97, with the higher score the better visual acuity.
Time frame: at 1 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-Lucentis Monthly | Visual-acuity Score and Snellen Equivalent (Continuous) | 68.8 No. of Letters | Standard Deviation 17.7 |
| 2-Avastin Monthly | Visual-acuity Score and Snellen Equivalent (Continuous) | 68.4 No. of Letters | Standard Deviation 18.2 |
| 3-Lucentis as Needed | Visual-acuity Score and Snellen Equivalent (Continuous) | 68.4 No. of Letters | Standard Deviation 16.4 |
| 4-Avastin as Needed | Visual-acuity Score and Snellen Equivalent (Continuous) | 66.5 No. of Letters | Standard Deviation 19 |
Secondary
Visual-acuity Score and Snellen Equivalent (Frequency)
Time frame: at 1 Year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1-Lucentis Monthly | Visual-acuity Score and Snellen Equivalent (Frequency) | ≤37 letters, ≤20/200 | 18 Participants |
| 1-Lucentis Monthly | Visual-acuity Score and Snellen Equivalent (Frequency) | 38-52 letters, 20/100-160 | 23 Participants |
| 1-Lucentis Monthly | Visual-acuity Score and Snellen Equivalent (Frequency) | 83-97 letters, 20/12-20 | 42 Participants |
| 1-Lucentis Monthly | Visual-acuity Score and Snellen Equivalent (Frequency) | 68-82 letters, 20/25-40 | 149 Participants |
| 1-Lucentis Monthly | Visual-acuity Score and Snellen Equivalent (Frequency) | 53-67 letters, 20/50-80 | 52 Participants |
| 2-Avastin Monthly | Visual-acuity Score and Snellen Equivalent (Frequency) | 53-67 letters, 20/50-80 | 47 Participants |
| 2-Avastin Monthly | Visual-acuity Score and Snellen Equivalent (Frequency) | 83-97 letters, 20/12-20 | 45 Participants |
| 2-Avastin Monthly | Visual-acuity Score and Snellen Equivalent (Frequency) | 68-82 letters, 20/25-40 | 134 Participants |
| 2-Avastin Monthly | Visual-acuity Score and Snellen Equivalent (Frequency) | 38-52 letters, 20/100-160 | 21 Participants |
| 2-Avastin Monthly | Visual-acuity Score and Snellen Equivalent (Frequency) | ≤37 letters, ≤20/200 | 18 Participants |
| 3-Lucentis as Needed | Visual-acuity Score and Snellen Equivalent (Frequency) | 38-52 letters, 20/100-160 | 23 Participants |
| 3-Lucentis as Needed | Visual-acuity Score and Snellen Equivalent (Frequency) | ≤37 letters, ≤20/200 | 17 Participants |
| 3-Lucentis as Needed | Visual-acuity Score and Snellen Equivalent (Frequency) | 68-82 letters, 20/25-40 | 141 Participants |
| 3-Lucentis as Needed | Visual-acuity Score and Snellen Equivalent (Frequency) | 53-67 letters, 20/50-80 | 66 Participants |
| 3-Lucentis as Needed | Visual-acuity Score and Snellen Equivalent (Frequency) | 83-97 letters, 20/12-20 | 38 Participants |
| 4-Avastin as Needed | Visual-acuity Score and Snellen Equivalent (Frequency) | ≤37 letters, ≤20/200 | 23 Participants |
| 4-Avastin as Needed | Visual-acuity Score and Snellen Equivalent (Frequency) | 83-97 letters, 20/12-20 | 40 Participants |
| 4-Avastin as Needed | Visual-acuity Score and Snellen Equivalent (Frequency) | 53-67 letters, 20/50-80 | 57 Participants |
| 4-Avastin as Needed | Visual-acuity Score and Snellen Equivalent (Frequency) | 38-52 letters, 20/100-160 | 24 Participants |
| 4-Avastin as Needed | Visual-acuity Score and Snellen Equivalent (Frequency) | 68-82 letters, 20/25-40 | 127 Participants |