Trial · NCT00593450

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

NCT00593450, Phase 3, Completed, University of Pennsylvania; results first posted 2012-08-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial. Trials, record NCT00593450. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00593450

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
NCT number: NCT00593450
Status: Completed
Phases: Phase 3
Enrollment: 1,208 participants, actual
Lead sponsor: University of Pennsylvania
Conditions: Age Related Macular Degeneration
Interventions: ranibizumab, bevacizumab
First posted: 2008-01-15
Last updated: 2017-08-21
Results first posted: 2012-08-30

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	Change From Baseline Visual-acuity Score (Frequency)	Baseline and 1 Year
Secondary	Visual-acuity Score and Snellen Equivalent (Frequency)	at 1 Year
Secondary	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.
Secondary	Number of Treatments	1 Year	Cumulative over the 1 year of trial
Secondary	Average Cost of Drug/Patient	at 1 Year
Secondary	Total Thickness at Fovea	at 1 Year
Secondary	Total Thickness Change From Baseline at Fovea	Baseline and 1 Year
Secondary	Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea	at 1 Year
Secondary	Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea	Baseline and 1 Year

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Change From Baseline Visual-acuity Score (Frequency)	Baseline and 1 Year		Participants	NUMBER
PRIMARY	Change From Baseline in Visual-acuity Score (Continuous)	Baseline and 1 Year	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.	No. of Letters	MEAN
SECONDARY	Visual-acuity Score and Snellen Equivalent (Frequency)	at 1 Year		Participants	NUMBER
SECONDARY	Visual-acuity Score and Snellen Equivalent (Continuous)	at 1 Year		No. of Letters	MEAN
SECONDARY	Number of Treatments	1 Year		Number of Treatments	MEAN
SECONDARY	Average Cost of Drug/Patient	at 1 Year		US dollars per patient	MEAN
SECONDARY	Total Thickness at Fovea	at 1 Year		μm	MEAN
SECONDARY	Total Thickness Change From Baseline at Fovea	Baseline and 1 Year		μm	MEAN
SECONDARY	Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea	at 1 Year		μm	MEAN
SECONDARY	Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea	Baseline and 1 Year		μm	MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group112

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Change From Baseline Visual-acuity Score (Frequency)	1-Lucentis Monthly	Increase of ≥15 letters	97	Participants
Change From Baseline Visual-acuity Score (Frequency)	2-Avastin Monthly	Increase of ≥15 letters	83	Participants
Change From Baseline Visual-acuity Score (Frequency)	3-Lucentis as Needed	Increase of ≥15 letters	71	Participants
Change From Baseline Visual-acuity Score (Frequency)	4-Avastin as Needed	Increase of ≥15 letters	76	Participants
Change From Baseline Visual-acuity Score (Frequency)	1-Lucentis Monthly	Increase of 5-14 letters	90	Participants
Change From Baseline Visual-acuity Score (Frequency)	2-Avastin Monthly	Increase of 5-14 letters	98	Participants
Change From Baseline Visual-acuity Score (Frequency)	3-Lucentis as Needed	Increase of 5-14 letters	103	Participants
Change From Baseline Visual-acuity Score (Frequency)	4-Avastin as Needed	Increase of 5-14 letters	90	Participants
Change From Baseline Visual-acuity Score (Frequency)	1-Lucentis Monthly	Change of ≤4 letters	62	Participants
Change From Baseline Visual-acuity Score (Frequency)	2-Avastin Monthly	Change of ≤4 letters	50	Participants

1 to 10 of 112Source ClinicalTrials.gov

See all 112 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	1-Lucentis Monthly	301
Overall Study	STARTED	2-Avastin Monthly	286
Overall Study	STARTED	3-Lucentis as Needed	298
Overall Study	STARTED	4-Avastin as Needed	300
Overall Study	COMPLETED	1-Lucentis Monthly	284
Overall Study	COMPLETED	2-Avastin Monthly	265
Overall Study	COMPLETED	3-Lucentis as Needed	285
Overall Study	COMPLETED	4-Avastin as Needed	271
Overall Study	NOT COMPLETED	1-Lucentis Monthly	17
Overall Study	NOT COMPLETED	2-Avastin Monthly	21

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events68

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Endophthalmitis	Eye disorders	1-Lucentis Monthly	2	301
other	Endophthalmitis	Eye disorders	2-Avastin Monthly	4	286
other	Endophthalmitis	Eye disorders	3-Lucentis as Needed	0	298
other	Endophthalmitis	Eye disorders	4-Avastin as Needed	0	300
other	Pseudoendophthalmitis	Eye disorders	1-Lucentis Monthly	1	301
other	Pseudoendophthalmitis	Eye disorders	2-Avastin Monthly	0	286
other	Pseudoendophthalmitis	Eye disorders	3-Lucentis as Needed	0	298
other	Pseudoendophthalmitis	Eye disorders	4-Avastin as Needed	0	300
serious	Any other system organ class	General disorders	1-Lucentis Monthly	18	301
serious	Any other system organ class	General disorders	2-Avastin Monthly	26	286

1 to 10 of 68Source ClinicalTrials.gov

See all 68 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1-Lucentis Monthly
Total, all-cause mortality	2-Avastin Monthly
Total, all-cause mortality	3-Lucentis as Needed
Total, all-cause mortality	4-Avastin as Needed
Total, other adverse events	1-Lucentis Monthly	3	301
Total, other adverse events	2-Avastin Monthly	4	286
Total, other adverse events	3-Lucentis as Needed	0	298
Total, other adverse events	4-Avastin as Needed	0	300
Total, serious adverse events	1-Lucentis Monthly	53	301
Total, serious adverse events	2-Avastin Monthly	64	286

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers47

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20519677	BACKGROUND	PubMed
21526923	RESULT	PubMed
22150050	RESULT	PubMed
22452699	RESULT	PubMed
22512984	RESULT	PubMed
22555112	RESULT	PubMed
22939114	RESULT	PubMed
23047002	RESULT	PubMed
23337555	RESULT	PubMed
23642377	RESULT	PubMed

1 to 10 of 47

See all 47 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10EY017823	Coordinating Center for the Comparison of AMD Treatments Trial	MAGUIRE, MAUREEN G	UNIVERSITY OF PENNSYLVANIA	NATIONAL EYE INSTITUTE	2006 to 2012

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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