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Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial

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ClinicalTrials.gov Identifier: NCT00593450
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : August 30, 2012
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Age Related Macular Degeneration
Interventions Drug: ranibizumab
Drug: bevacizumab
Enrollment 1208
Recruitment Details  
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.
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description 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. 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. Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity. Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Period Title: Overall Study
Started 301 286 298 300
Completed 284 265 285 271
Not Completed 17 21 13 29
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed Total
Hide Arm/Group Description 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. 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. Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity. Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity. Total of all reporting groups
Overall Number of Baseline Participants 301 286 298 300 1185
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 301 participants 286 participants 298 participants 300 participants 1185 participants
79.2  (7.4) 80.1  (7.3) 78.4  (7.8) 79.3  (7.6) 79.3  (7.5)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants 286 participants 298 participants 300 participants 1185 participants
50-59 years 2 1 6 2 11
60-69 years 33 28 31 34 126
70-79 years 102 84 115 103 404
80-89 years 142 150 126 142 560
>=90 years 22 23 20 19 84
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 301 participants 286 participants 298 participants 300 participants 1185 participants
Female
183
  60.8%
180
  62.9%
185
  62.1%
184
  61.3%
732
  61.8%
Male
118
  39.2%
106
  37.1%
113
  37.9%
116
  38.7%
453
  38.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants 286 participants 298 participants 300 participants 1185 participants
White 297 281 296 294 1168
Other 4 5 2 6 17
History of myocardial infarction  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants 286 participants 298 participants 300 participants 1185 participants
Yes 34 40 30 36 140
No 267 246 268 264 1045
History of stroke  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants 286 participants 298 participants 300 participants 1185 participants
Yes 14 18 22 16 70
No 287 268 276 284 1115
History of transient ischemic attack  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants 286 participants 298 participants 300 participants 1185 participants
Yes 12 25 12 19 68
No 289 261 286 281 1117
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 301 participants 286 participants 298 participants 300 participants 1185 participants
134  (18) 135  (19) 136  (17) 135  (17) 135  (18)
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 301 participants 286 participants 298 participants 300 participants 1185 participants
75  (10) 75  (10) 76  (9) 75  (10) 75  (10)
Visual-acuity score and Snellen equivalent  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants 286 participants 298 participants 300 participants 1185 participants
68-82 letters, 20/25-40 111 94 116 103 424
53-67 letters, 20/50-80 98 118 108 119 443
38-52 letters, 20/100-160 67 53 58 58 236
23-37 letters, 20/200-320 25 21 16 20 82
Visual-acuity score and Snellen equivalent   [1] 
Mean (Standard Deviation)
Unit of measure:  Letters
Number Analyzed 301 participants 286 participants 298 participants 300 participants 1185 participants
60.1  (14.3) 60.2  (13.1) 61.5  (13.2) 60.4  (13.4) 60.5  (13.5)
[1]
Measure Description:

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 visual acuity letter score is ranged from 23 to 82, with the higher score the better visual acuity.

Total thickness at fovea  
Mean (Standard Deviation)
Unit of measure:  μm
Number Analyzed 301 participants 286 participants 298 participants 300 participants 1185 participants
458  (184) 463  (196) 458  (193) 461  (175) 460  (187)
Retinal thickness plus subfoveal-fluid thickness at fovea  
Mean (Standard Deviation)
Unit of measure:  Microns
Number Analyzed 301 participants 286 participants 298 participants 300 participants 1185 participants
251  (122) 254  (121) 247  (122) 252  (115) 251  (120)
Foveal center involvement  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants 286 participants 298 participants 300 participants 1185 participants
Choroidal neovacularization 176 153 176 183 688
Fluid 85 81 77 72 315
Hemorrhage 20 24 24 25 93
Other 18 20 15 18 71
No choroidal neovascularization or can't grade 2 8 6 2 18
1.Primary Outcome
Title Change From Baseline in Visual-acuity Score (Continuous)
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 284 265 285 271
Mean (Standard Deviation)
Unit of Measure: No. of Letters
8.5  (14.1) 8.0  (15.8) 6.8  (13.1) 5.9  (15.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1-Lucentis Monthly, 2-Avastin Monthly
Comments 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%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study [ETDRS] visual-acuity chart)
Statistical Test of Hypothesis P-Value 0.16
Comments This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.
Method ANOVA
Comments We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval (2-Sided) 99.2%
-3.9 to 2.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.7
Estimation Comments Estimate = Mean VA Change in Avastin Monthly Group - Mean VA Change in Lucentis Monthly Group
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 3-Lucentis as Needed, 4-Avastin as Needed
Comments 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%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study [ETDRS] visual-acuity chart)
Statistical Test of Hypothesis P-Value 0.16
Comments This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.
Method ANOVA
Comments We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.8
Confidence Interval (2-Sided) 99.2%
-4.1 to 2.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.6
Estimation Comments Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis as Needed Group
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1-Lucentis Monthly, 3-Lucentis as Needed
Comments 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%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study [ETDRS] visual-acuity chart)
Statistical Test of Hypothesis P-Value 0.16
Comments This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.
Method ANOVA
Comments We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.7
Confidence Interval (2-Sided) 99.2%
-4.7 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.5
Estimation Comments Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Lucentis Monthly Group
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 2-Avastin Monthly, 4-Avastin as Needed
Comments 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%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study [ETDRS] visual-acuity chart)
Statistical Test of Hypothesis P-Value 0.16
Comments This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.
Method ANOVA
Comments We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.1
Confidence Interval (2-Sided) 99.2%
-5.7 to 1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.9
Estimation Comments Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Avastin Monthly Group
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 2-Avastin Monthly, 3-Lucentis as Needed
Comments 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%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study [ETDRS] visual-acuity chart)
Statistical Test of Hypothesis P-Value 0.16
Comments This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.
Method ANOVA
Comments We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.2
Confidence Interval (2-Sided) 99.2%
-4.5 to 2.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.7
Estimation Comments Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Avastin Monthly Group
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 1-Lucentis Monthly, 4-Avastin as Needed
Comments 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%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study [ETDRS] visual-acuity chart)
Statistical Test of Hypothesis P-Value 0.16
Comments This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.
Method ANOVA
Comments We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.6
Confidence Interval (2-Sided) 99.2%
-5.9 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.7
Estimation Comments Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis Monthly Group
2.Secondary Outcome
Title Change From Baseline Visual-acuity Score (Frequency)
Hide Description [Not Specified]
Time Frame Baseline and 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 284 265 285 271
Measure Type: Number
Unit of Measure: Participants
Increase of ≥15 letters 97 83 71 76
Increase of 5-14 letters 90 98 103 90
Change of ≤4 letters 62 50 75 59
Decrease of 5-14 letters 19 18 23 23
Decrease of ≥15 letters 16 16 13 23
3.Secondary Outcome
Title Visual-acuity Score and Snellen Equivalent (Frequency)
Hide Description [Not Specified]
Time Frame at 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 284 265 285 271
Measure Type: Number
Unit of Measure: Participants
83-97 letters, 20/12-20 42 45 38 40
68-82 letters, 20/25-40 149 134 141 127
53-67 letters, 20/50-80 52 47 66 57
38-52 letters, 20/100-160 23 21 23 24
≤37 letters, ≤20/200 18 18 17 23
4.Secondary Outcome
Title Visual-acuity Score and Snellen Equivalent (Continuous)
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 284 265 285 271
Mean (Standard Deviation)
Unit of Measure: No. of Letters
68.8  (17.7) 68.4  (18.2) 68.4  (16.4) 66.5  (19.0)
5.Secondary Outcome
Title Number of Treatments
Hide Description Cumulative over the 1 year of trial
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 284 265 285 271
Mean (Standard Error)
Unit of Measure: Number of Treatments
11.7  (1.5) 11.9  (1.2) 6.9  (3.0) 7.7  (3.5)
6.Secondary Outcome
Title Average Cost of Drug/Patient
Hide Description [Not Specified]
Time Frame at 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 284 265 285 271
Mean (Standard Deviation)
Unit of Measure: US dollars per patient
23400  (3000) 595  (60) 13800  (6000) 385  (175)
7.Secondary Outcome
Title Total Thickness at Fovea
Hide Description [Not Specified]
Time Frame at 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 280 261 281 265
Mean (Standard Deviation)
Unit of Measure: μm
266  (125) 300  (149) 294  (139) 308  (127)
8.Secondary Outcome
Title Total Thickness Change From Baseline at Fovea
Hide Description [Not Specified]
Time Frame Baseline and 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 280 260 278 265
Mean (Standard Deviation)
Unit of Measure: μm
-196  (176) -164  (181) -168  (186) -152  (178)
9.Secondary Outcome
Title Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea
Hide Description [Not Specified]
Time Frame at 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 280 261 281 265
Mean (Standard Deviation)
Unit of Measure: μm
152  (57) 172  (81) 166  (66) 172  (68)
10.Secondary Outcome
Title Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea
Hide Description [Not Specified]
Time Frame Baseline and 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 280 260 278 265
Mean (Standard Deviation)
Unit of Measure: μm
-100  (130) -79  (132) -81  (134) -79  (123)
11.Secondary Outcome
Title Fluid on Optical Coherence Tomography
Hide Description [Not Specified]
Time Frame at 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 284 265 285 271
Measure Type: Number
Unit of Measure: Participants
Absent 124 69 68 52
Present 151 188 203 214
Data missing 9 8 14 5
12.Secondary Outcome
Title Dye Leakage on Angiogram
Hide Description [Not Specified]
Time Frame at 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 284 265 285 271
Measure Type: Number
Unit of Measure: Participants
Absent 167 153 133 111
Present 97 100 137 145
Data missing 20 12 15 15
13.Secondary Outcome
Title Area of Lesion
Hide Description [Not Specified]
Time Frame at 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 256 243 265 249
Mean (Standard Deviation)
Unit of Measure: mm^2
6.6  (6.8) 6.5  (6.7) 7.3  (6.5) 7.0  (7.5)
14.Secondary Outcome
Title Area of Lesion Change From Baseline
Hide Description [Not Specified]
Time Frame Baseline and 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 250 238 259 241
Mean (Standard Deviation)
Unit of Measure: mm^2
-0.1  (5.2) 0.3  (4.9) 0.6  (6.2) 1.3  (6.6)
15.Secondary Outcome
Title Change in Systolic Blood Pressure From Baseline
Hide Description [Not Specified]
Time Frame Baseline and 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 239 226 250 232
Mean (Standard Deviation)
Unit of Measure: mm Hg
-2.1  (22.4) -5.4  (18.2) -5.2  (20.3) -4.5  (20.0)
16.Secondary Outcome
Title Change in Diastolic Blood Pressure From Baseline
Hide Description [Not Specified]
Time Frame Baseline and 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description:
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.
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.
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Overall Number of Participants Analyzed 239 226 250 232
Mean (Standard Deviation)
Unit of Measure: mm Hg
-0.9  (11.9) -1.4  (11.2) -1.9  (10.2) -2.1  (10.8)
Time Frame Adverse events were collected at 1 year.
Adverse Event Reporting Description Adverse events were ascertained through monthly questioning of patients by study coordinators who were aware of study-group assignments; events were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) system, version 10. A medical monitor who was unaware of study-group assignments reviewed serious adverse events.
 
Arm/Group Title 1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Hide Arm/Group Description 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. 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. Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity. Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
All-Cause Mortality
1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   53/301 (17.61%)   64/286 (22.38%)   61/298 (20.47%)   77/300 (25.67%) 
Blood and lymphatic system disorders         
Death from vascular causes  1  2/301 (0.66%)  2/286 (0.70%)  2/298 (0.67%)  5/300 (1.67%) 
Hypertension  1  0/301 (0.00%)  2/286 (0.70%)  0/298 (0.00%)  0/300 (0.00%) 
Venous thrombotic event  1  0/301 (0.00%)  4/286 (1.40%)  2/298 (0.67%)  1/300 (0.33%) 
Cardiac disorders         
Cardiac disorder  1  10/301 (3.32%)  16/286 (5.59%)  12/298 (4.03%)  13/300 (4.33%) 
Nonfatal myocardial infarction  1  2/301 (0.66%)  2/286 (0.70%)  3/298 (1.01%)  1/300 (0.33%) 
Nonfatal stroke  1  3/301 (1.00%)  2/286 (0.70%)  1/298 (0.34%)  2/300 (0.67%) 
Transient ischemic attack  1  1/301 (0.33%)  0/286 (0.00%)  2/298 (0.67%)  3/300 (1.00%) 
Gastrointestinal disorders         
Gastrointestinal disorder  1  3/301 (1.00%)  6/286 (2.10%)  2/298 (0.67%)  9/300 (3.00%) 
General disorders         
Any other system organ class  1  18/301 (5.98%)  26/286 (9.09%)  16/298 (5.37%)  28/300 (9.33%) 
Death from any cause  1  4/301 (1.33%)  4/286 (1.40%)  5/298 (1.68%)  11/300 (3.67%) 
Infections and infestations         
Infection  1  6/301 (1.99%)  11/286 (3.85%)  12/298 (4.03%)  18/300 (6.00%) 
Injury, poisoning and procedural complications         
Injury or procedural complication  1  7/301 (2.33%)  11/286 (3.85%)  8/298 (2.68%)  9/300 (3.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Benignor malignant neoplasm  1  7/301 (2.33%)  5/286 (1.75%)  10/298 (3.36%)  9/300 (3.00%) 
Nervous system disorders         
Nervous system disorder  1  6/301 (1.99%)  9/286 (3.15%)  12/298 (4.03%)  9/300 (3.00%) 
Surgical and medical procedures         
Surgical or medical procedure  1  4/301 (1.33%)  6/286 (2.10%)  4/298 (1.34%)  8/300 (2.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1-Lucentis Monthly 2-Avastin Monthly 3-Lucentis as Needed 4-Avastin as Needed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/301 (1.00%)   4/286 (1.40%)   0/298 (0.00%)   0/300 (0.00%) 
Eye disorders         
Endophthalmitis  1  2/301 (0.66%)  4/286 (1.40%)  0/298 (0.00%)  0/300 (0.00%) 
Pseudoendophthalmitis  1  1/301 (0.33%)  0/286 (0.00%)  0/298 (0.00%)  0/300 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Dr. Grunwald reports receiving consulting fees from GlaxoSmithKline; and Dr. Jaffe, consulting fees from Neurotech and SurModics. No other potential conflict of interest relevant to this article was reported.
Results Point of Contact
Name/Title: Dr. Maureen Maguire
Organization: CATT Research Group
Phone: 215-615-1501
Publications of Results:
Martin DF, Maguire MG, Fine SL. Ranibizumab and bevacizumab for AMD. Authors reply. N Engl J Med 2011; 365:2237
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00593450     History of Changes
Other Study ID Numbers: NEI-137
U10EY017823 ( U.S. NIH Grant/Contract )
First Submitted: January 3, 2008
First Posted: January 15, 2008
Results First Submitted: June 18, 2012
Results First Posted: August 30, 2012
Last Update Posted: August 21, 2017