Trial Outcomes & Findings for Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (NCT NCT00593450)

Last Updated: 2017-08-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1208 participants

Primary outcome timeframe

Baseline and 1 Year

Results posted on

2017-08-21

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Overall Study STARTED	301	286	298	300
Overall Study COMPLETED	284	265	285	271
Overall Study NOT COMPLETED	17	21	13	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1-Lucentis Monthly n=301 Participants 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.	2-Avastin Monthly n=286 Participants 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.	3-Lucentis as Needed n=298 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=300 Participants 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 n=1185 Participants Total of all reporting groups
Age, Continuous	79.2 years STANDARD_DEVIATION 7.4 • n=5 Participants	80.1 years STANDARD_DEVIATION 7.3 • n=7 Participants	78.4 years STANDARD_DEVIATION 7.8 • n=5 Participants	79.3 years STANDARD_DEVIATION 7.6 • n=4 Participants	79.3 years STANDARD_DEVIATION 7.5 • n=21 Participants
Age, Customized 50-59 years	2 participants n=5 Participants	1 participants n=7 Participants	6 participants n=5 Participants	2 participants n=4 Participants	11 participants n=21 Participants
Age, Customized 60-69 years	33 participants n=5 Participants	28 participants n=7 Participants	31 participants n=5 Participants	34 participants n=4 Participants	126 participants n=21 Participants
Age, Customized 70-79 years	102 participants n=5 Participants	84 participants n=7 Participants	115 participants n=5 Participants	103 participants n=4 Participants	404 participants n=21 Participants
Age, Customized 80-89 years	142 participants n=5 Participants	150 participants n=7 Participants	126 participants n=5 Participants	142 participants n=4 Participants	560 participants n=21 Participants
Age, Customized >=90 years	22 participants n=5 Participants	23 participants n=7 Participants	20 participants n=5 Participants	19 participants n=4 Participants	84 participants n=21 Participants
Sex: Female, Male Female	183 Participants n=5 Participants	180 Participants n=7 Participants	185 Participants n=5 Participants	184 Participants n=4 Participants	732 Participants n=21 Participants
Sex: Female, Male Male	118 Participants n=5 Participants	106 Participants n=7 Participants	113 Participants n=5 Participants	116 Participants n=4 Participants	453 Participants n=21 Participants
Race/Ethnicity, Customized White	297 Participants n=5 Participants	281 Participants n=7 Participants	296 Participants n=5 Participants	294 Participants n=4 Participants	1168 Participants n=21 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	17 Participants n=21 Participants
History of myocardial infarction Yes	34 Participants n=5 Participants	40 Participants n=7 Participants	30 Participants n=5 Participants	36 Participants n=4 Participants	140 Participants n=21 Participants
History of myocardial infarction No	267 Participants n=5 Participants	246 Participants n=7 Participants	268 Participants n=5 Participants	264 Participants n=4 Participants	1045 Participants n=21 Participants
History of stroke Yes	14 Participants n=5 Participants	18 Participants n=7 Participants	22 Participants n=5 Participants	16 Participants n=4 Participants	70 Participants n=21 Participants
History of stroke No	287 Participants n=5 Participants	268 Participants n=7 Participants	276 Participants n=5 Participants	284 Participants n=4 Participants	1115 Participants n=21 Participants
History of transient ischemic attack Yes	12 Participants n=5 Participants	25 Participants n=7 Participants	12 Participants n=5 Participants	19 Participants n=4 Participants	68 Participants n=21 Participants
History of transient ischemic attack No	289 Participants n=5 Participants	261 Participants n=7 Participants	286 Participants n=5 Participants	281 Participants n=4 Participants	1117 Participants n=21 Participants
Systolic blood pressure	134 mm Hg STANDARD_DEVIATION 18 • n=5 Participants	135 mm Hg STANDARD_DEVIATION 19 • n=7 Participants	136 mm Hg STANDARD_DEVIATION 17 • n=5 Participants	135 mm Hg STANDARD_DEVIATION 17 • n=4 Participants	135 mm Hg STANDARD_DEVIATION 18 • n=21 Participants
Diastolic blood pressure	75 mm Hg STANDARD_DEVIATION 10 • n=5 Participants	75 mm Hg STANDARD_DEVIATION 10 • n=7 Participants	76 mm Hg STANDARD_DEVIATION 9 • n=5 Participants	75 mm Hg STANDARD_DEVIATION 10 • n=4 Participants	75 mm Hg STANDARD_DEVIATION 10 • n=21 Participants
Visual-acuity score and Snellen equivalent 68-82 letters, 20/25-40	111 Participants n=5 Participants	94 Participants n=7 Participants	116 Participants n=5 Participants	103 Participants n=4 Participants	424 Participants n=21 Participants
Visual-acuity score and Snellen equivalent 53-67 letters, 20/50-80	98 Participants n=5 Participants	118 Participants n=7 Participants	108 Participants n=5 Participants	119 Participants n=4 Participants	443 Participants n=21 Participants
Visual-acuity score and Snellen equivalent 38-52 letters, 20/100-160	67 Participants n=5 Participants	53 Participants n=7 Participants	58 Participants n=5 Participants	58 Participants n=4 Participants	236 Participants n=21 Participants
Visual-acuity score and Snellen equivalent 23-37 letters, 20/200-320	25 Participants n=5 Participants	21 Participants n=7 Participants	16 Participants n=5 Participants	20 Participants n=4 Participants	82 Participants n=21 Participants
Visual-acuity score and Snellen equivalent	60.1 Letters STANDARD_DEVIATION 14.3 • n=5 Participants	60.2 Letters STANDARD_DEVIATION 13.1 • n=7 Participants	61.5 Letters STANDARD_DEVIATION 13.2 • n=5 Participants	60.4 Letters STANDARD_DEVIATION 13.4 • n=4 Participants	60.5 Letters STANDARD_DEVIATION 13.5 • n=21 Participants
Total thickness at fovea	458 μm STANDARD_DEVIATION 184 • n=5 Participants	463 μm STANDARD_DEVIATION 196 • n=7 Participants	458 μm STANDARD_DEVIATION 193 • n=5 Participants	461 μm STANDARD_DEVIATION 175 • n=4 Participants	460 μm STANDARD_DEVIATION 187 • n=21 Participants
Retinal thickness plus subfoveal-fluid thickness at fovea	251 microns STANDARD_DEVIATION 122 • n=5 Participants	254 microns STANDARD_DEVIATION 121 • n=7 Participants	247 microns STANDARD_DEVIATION 122 • n=5 Participants	252 microns STANDARD_DEVIATION 115 • n=4 Participants	251 microns STANDARD_DEVIATION 120 • n=21 Participants
Foveal center involvement Choroidal neovacularization	176 Participants n=5 Participants	153 Participants n=7 Participants	176 Participants n=5 Participants	183 Participants n=4 Participants	688 Participants n=21 Participants
Foveal center involvement Fluid	85 Participants n=5 Participants	81 Participants n=7 Participants	77 Participants n=5 Participants	72 Participants n=4 Participants	315 Participants n=21 Participants
Foveal center involvement Hemorrhage	20 Participants n=5 Participants	24 Participants n=7 Participants	24 Participants n=5 Participants	25 Participants n=4 Participants	93 Participants n=21 Participants
Foveal center involvement Other	18 Participants n=5 Participants	20 Participants n=7 Participants	15 Participants n=5 Participants	18 Participants n=4 Participants	71 Participants n=21 Participants
Foveal center involvement No choroidal neovascularization or can't grade	2 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	18 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=284 Participants 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.	2-Avastin Monthly n=265 Participants 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.	3-Lucentis as Needed n=285 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=271 Participants Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Change From Baseline in Visual-acuity Score (Continuous)	8.5 No. of Letters Standard Deviation 14.1	8.0 No. of Letters Standard Deviation 15.8	6.8 No. of Letters Standard Deviation 13.1	5.9 No. of Letters Standard Deviation 15.7

SECONDARY outcome

Timeframe: Baseline and 1 Year

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=284 Participants 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.	2-Avastin Monthly n=265 Participants 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.	3-Lucentis as Needed n=285 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=271 Participants Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Change From Baseline Visual-acuity Score (Frequency) Increase of ≥15 letters	97 Participants	83 Participants	71 Participants	76 Participants
Change From Baseline Visual-acuity Score (Frequency) Increase of 5-14 letters	90 Participants	98 Participants	103 Participants	90 Participants
Change From Baseline Visual-acuity Score (Frequency) Change of ≤4 letters	62 Participants	50 Participants	75 Participants	59 Participants
Change From Baseline Visual-acuity Score (Frequency) Decrease of 5-14 letters	19 Participants	18 Participants	23 Participants	23 Participants
Change From Baseline Visual-acuity Score (Frequency) Decrease of ≥15 letters	16 Participants	16 Participants	13 Participants	23 Participants

SECONDARY outcome

Timeframe: at 1 Year

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=284 Participants 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.	2-Avastin Monthly n=265 Participants 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.	3-Lucentis as Needed n=285 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=271 Participants Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Visual-acuity Score and Snellen Equivalent (Frequency) 83-97 letters, 20/12-20	42 Participants	45 Participants	38 Participants	40 Participants
Visual-acuity Score and Snellen Equivalent (Frequency) 68-82 letters, 20/25-40	149 Participants	134 Participants	141 Participants	127 Participants
Visual-acuity Score and Snellen Equivalent (Frequency) 53-67 letters, 20/50-80	52 Participants	47 Participants	66 Participants	57 Participants
Visual-acuity Score and Snellen Equivalent (Frequency) 38-52 letters, 20/100-160	23 Participants	21 Participants	23 Participants	24 Participants
Visual-acuity Score and Snellen Equivalent (Frequency) ≤37 letters, ≤20/200	18 Participants	18 Participants	17 Participants	23 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=284 Participants 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.	2-Avastin Monthly n=265 Participants 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.	3-Lucentis as Needed n=285 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=271 Participants Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Visual-acuity Score and Snellen Equivalent (Continuous)	68.8 No. of Letters Standard Deviation 17.7	68.4 No. of Letters Standard Deviation 18.2	68.4 No. of Letters Standard Deviation 16.4	66.5 No. of Letters Standard Deviation 19.0

SECONDARY outcome

Timeframe: 1 Year

Cumulative over the 1 year of trial

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=284 Participants 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.	2-Avastin Monthly n=265 Participants 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.	3-Lucentis as Needed n=285 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=271 Participants Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Number of Treatments	11.7 Number of Treatments Standard Error 1.5	11.9 Number of Treatments Standard Error 1.2	6.9 Number of Treatments Standard Error 3.0	7.7 Number of Treatments Standard Error 3.5

SECONDARY outcome

Timeframe: at 1 Year

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=284 Participants 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.	2-Avastin Monthly n=265 Participants 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.	3-Lucentis as Needed n=285 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=271 Participants Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Average Cost of Drug/Patient	23400 US dollars per patient Standard Deviation 3000	595 US dollars per patient Standard Deviation 60	13800 US dollars per patient Standard Deviation 6000	385 US dollars per patient Standard Deviation 175

SECONDARY outcome

Timeframe: at 1 Year

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=280 Participants 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.	2-Avastin Monthly n=261 Participants 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.	3-Lucentis as Needed n=281 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=265 Participants 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 Thickness at Fovea	266 μm Standard Deviation 125	300 μm Standard Deviation 149	294 μm Standard Deviation 139	308 μm Standard Deviation 127

SECONDARY outcome

Timeframe: Baseline and 1 Year

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=280 Participants 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.	2-Avastin Monthly n=260 Participants 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.	3-Lucentis as Needed n=278 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=265 Participants 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 Thickness Change From Baseline at Fovea	-196 μm Standard Deviation 176	-164 μm Standard Deviation 181	-168 μm Standard Deviation 186	-152 μm Standard Deviation 178

SECONDARY outcome

Timeframe: at 1 Year

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=280 Participants 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.	2-Avastin Monthly n=261 Participants 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.	3-Lucentis as Needed n=281 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=265 Participants Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea	152 μm Standard Deviation 57	172 μm Standard Deviation 81	166 μm Standard Deviation 66	172 μm Standard Deviation 68

SECONDARY outcome

Timeframe: Baseline and 1 Year

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=280 Participants 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.	2-Avastin Monthly n=260 Participants 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.	3-Lucentis as Needed n=278 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=265 Participants Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea	-100 μm Standard Deviation 130	-79 μm Standard Deviation 132	-81 μm Standard Deviation 134	-79 μm Standard Deviation 123

SECONDARY outcome

Timeframe: at 1 Year

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=284 Participants 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.	2-Avastin Monthly n=265 Participants 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.	3-Lucentis as Needed n=285 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=271 Participants Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Fluid on Optical Coherence Tomography Absent	124 Participants	69 Participants	68 Participants	52 Participants
Fluid on Optical Coherence Tomography Present	151 Participants	188 Participants	203 Participants	214 Participants
Fluid on Optical Coherence Tomography Data missing	9 Participants	8 Participants	14 Participants	5 Participants

SECONDARY outcome

Timeframe: at 1 Year

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=284 Participants 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.	2-Avastin Monthly n=265 Participants 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.	3-Lucentis as Needed n=285 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=271 Participants Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Dye Leakage on Angiogram Absent	167 Participants	153 Participants	133 Participants	111 Participants
Dye Leakage on Angiogram Present	97 Participants	100 Participants	137 Participants	145 Participants
Dye Leakage on Angiogram Data missing	20 Participants	12 Participants	15 Participants	15 Participants

SECONDARY outcome

Timeframe: at 1 Year

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=256 Participants 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.	2-Avastin Monthly n=243 Participants 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.	3-Lucentis as Needed n=265 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=249 Participants Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Area of Lesion	6.6 mm^2 Standard Deviation 6.8	6.5 mm^2 Standard Deviation 6.7	7.3 mm^2 Standard Deviation 6.5	7.0 mm^2 Standard Deviation 7.5

SECONDARY outcome

Timeframe: Baseline and 1 Year

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=250 Participants 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.	2-Avastin Monthly n=238 Participants 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.	3-Lucentis as Needed n=259 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=241 Participants Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Area of Lesion Change From Baseline	-0.1 mm^2 Standard Deviation 5.2	0.3 mm^2 Standard Deviation 4.9	0.6 mm^2 Standard Deviation 6.2	1.3 mm^2 Standard Deviation 6.6

SECONDARY outcome

Timeframe: Baseline and 1 Year

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=239 Participants 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.	2-Avastin Monthly n=226 Participants 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.	3-Lucentis as Needed n=250 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=232 Participants Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Change in Systolic Blood Pressure From Baseline	-2.1 mm Hg Standard Deviation 22.4	-5.4 mm Hg Standard Deviation 18.2	-5.2 mm Hg Standard Deviation 20.3	-4.5 mm Hg Standard Deviation 20.0

SECONDARY outcome

Timeframe: Baseline and 1 Year

Outcome measures

Outcome measures
Measure	1-Lucentis Monthly n=239 Participants 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.	2-Avastin Monthly n=226 Participants 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.	3-Lucentis as Needed n=250 Participants Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=232 Participants Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Change in Diastolic Blood Pressure From Baseline	-0.9 mm Hg Standard Deviation 11.9	-1.4 mm Hg Standard Deviation 11.2	-1.9 mm Hg Standard Deviation 10.2	-2.1 mm Hg Standard Deviation 10.8

Adverse Events

1-Lucentis Monthly

Serious events: 53 serious events

Other events: 3 other events

Deaths: 0 deaths

2-Avastin Monthly

Serious events: 64 serious events

Other events: 4 other events

Deaths: 0 deaths

3-Lucentis as Needed

Serious events: 61 serious events

Other events: 0 other events

Deaths: 0 deaths

4-Avastin as Needed

Serious events: 77 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	1-Lucentis Monthly n=301 participants at risk 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.	2-Avastin Monthly n=286 participants at risk 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.	3-Lucentis as Needed n=298 participants at risk Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.	4-Avastin as Needed n=300 participants at risk Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Eye disorders Endophthalmitis	0.66% 2/301 • Adverse events were collected at 1 year. 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.	1.4% 4/286 • Adverse events were collected at 1 year. 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.	0.00% 0/298 • Adverse events were collected at 1 year. 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.	0.00% 0/300 • Adverse events were collected at 1 year. 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.
Eye disorders Pseudoendophthalmitis	0.33% 1/301 • Adverse events were collected at 1 year. 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.	0.00% 0/286 • Adverse events were collected at 1 year. 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.	0.00% 0/298 • Adverse events were collected at 1 year. 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.	0.00% 0/300 • Adverse events were collected at 1 year. 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.

Additional Information

Dr. Maureen Maguire

CATT Research Group

Phone: 215-615-1501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER