A Multi-Center Trial To Evaluate The Safety And Efficacy... | NCT00605280 | Trialant
NCT00605280
Sponsor
Pfizer
Status
Completed
Last Update Posted
Nov 16, 2018Actual
Enrollment
317Actual
Phase
Phase 2Phase 3
Conditions
Macular Edema Associated With Diabetes Mellitus
Interventions
Standard of Care
Macugen
Countries
United States
Australia
Austria
Brazil
Canada
Colombia
Czechia
Denmark
France
Germany
Greece
India
Italy
Netherlands
Portugal
South Africa
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00605280
Obsolete or Duplicate NCT IDs
NCT00148811
Organization Study
A5751013
Secondary IDs
ID
Type
Description
Link
EOP1013H
Brief Title
A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.
Official Title
A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Trial, In Parallel Groups, To Compare The Safety And Efficacy Of Intravitreous Injections Of 0.3 Mg Pegaptanib Sodium (Macugen®), Given As Often As Every 6 Weeks For 2 Years, To Sham Injections In Subjects With Diabetic Macular Edema (DME) Involving The Center Of The Macula With An Open-Label Macugen Year 3 Extension.
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Oct 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2005
Primary Completion Date
Nov 2009Actual
Completion Date
Jul 2011Actual
First Submitted Date
Jan 18, 2008
First Submission Date that Met QC Criteria
Jan 30, 2008
First Posted Date
Jan 31, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 18, 2010
Results First Submitted that Met QC Criteria
Mar 3, 2011
Results First Posted Date
Mar 30, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 18, 2018
Last Update Posted Date
Nov 16, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.
Clinicians decision to use optional laser therapy.
Sham Control
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year
Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts
Baseline, Year 1
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Baseline, Year 2
Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year
Loftus JV, Sultan MB, Pleil AM; Macugen 1013 Study Group. Changes in vision- and health-related quality of life in patients with diabetic macular edema treated with pegaptanib sodium or sham. Invest Ophthalmol Vis Sci. 2011 Sep 29;52(10):7498-505. doi: 10.1167/iovs.11-7613.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Original protocol included 0.3, 0.03, and 0.003 milligram (mg) pegaptanib sodium and sham treatment groups; the 0.03 and 0.003 mg doses were removed, affected participants given option of receiving 0.3 mg injections of pegaptanib sodium or study withdraw. Later, participants who hadn't completed Year 2 were eligible to enroll in Year 3 extension.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
0.3 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
FG001
Periods
Title
Milestones
Reasons Not Completed
Year 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Macugen
Drug
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.
Macugen
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Baseline, Year 1
Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Baseline, Year 2
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year
Retinopathy changes were monitored using fundus photography and fluorescein angiograph (FA) assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.
Baseline, Year 1
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year
Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.
Baseline, Year 1
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years
Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.
Baseline, Year 2
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years
Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.
Baseline, Year 2
Change From Baseline in Mean VA Score at 1 Year
Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.
Baseline, Year 1
Change From Baseline in Mean VA Score at 2 Years
Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.
Baseline, Year 2
Number of Participants Requiring Focal or Grid Laser Treatment During Year 1
Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation
1 year
Number of Participants Requiring Focal or Grid Laser Treatment During Year 2
Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation
Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. The 0.03 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks for 2 years or withdrawing from the study.
FG002
0.003 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. The 0.003 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from the study.
FG003
Sham
Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
FG000145 subjects
FG00122 subjects
FG0027 subjects
FG003143 subjects
Received 0.3 mg Treatment
FG000144 subjects
FG00113 subjects
FG0023 subjects
FG0030 subjects
COMPLETED
FG000126 subjects
FG00111 subjects
FG0026 subjects
FG003124 subjects
NOT COMPLETED
FG00019 subjects
FG00111 subjects
FG0021 subjects
FG00319 subjects
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Adverse Event
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0035 subjects
Physician Decision
FG0007 subjects
FG0014 subjects
FG0020 subjects
FG0036 subjects
Withdrawal by Subject
FG0002 subjects
FG0014 subjects
FG0020 subjects
FG0034 subjects
Other
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
Lost to Follow-up or Patient non-comply
FG0005 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
Year 2
Type
Comment
Milestone Data
STARTED
FG000126 subjects
FG00111 subjects
FG0026 subjects
FG003124 subjects
Received 0.3 mg Treatment
FG000126 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
COMPLETED
FG000102 subjects
FG0015 subjects
FG0020 subjects
FG003102 subjects
NOT COMPLETED
FG00024 subjects
FG0016 subjects
FG0026 subjects
FG00322 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0010 subjects
FG0022 subjects
FG003
Year 3 Extension
Type
Comment
Milestone Data
STARTED
FG00046 subjects
FG0010 subjects
FG0020 subjects
FG00354 subjects
Received 0.3 mg Treatment
FG00046 subjects
FG0010 subjects
FG0020 subjects
FG00354 subjects
COMPLETED
FG00038 subjects
FG0010 subjects
FG0020 subjects
FG00345 subjects
NOT COMPLETED
FG0008 subjects
FG0010 subjects
FG0020 subjects
FG0039 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
0.3 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
BG001
Sham
Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
BG002
0.03 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. The 0.03 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from study.
BG003
0.003 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. The 0.003 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from study.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000145
BG001143
BG00222
BG0037
BG004317
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00062.5± 9.2
BG00162.4± 10.3
BG00264.7± 8.6
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00059
BG00165
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year
Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts
Modified Intent-to-Treat (MITT)1 population:participants with at least 1 dose of study treatment who completed baseline VA, had at least 1 post baseline VA assessment within 1 year; 2 sites not analyzed due to Good Clinical Practice deviations; the 0.03 and 0.003mg pegaptanib arms not analyzed for efficacy. Last Observation Carried Forward (LOCF).
Posted
Number
Participants
Baseline, Year 1
ID
Title
Description
OG000
0.3 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
OG001
Sham
Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
Units
Counts
Participants
OG000133
OG001127
Title
Denominators
Categories
Title
Measurements
OG00049
OG00125
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0047
Adjusted for glycolated hemoglobin (HbA1c), systolic blood pressure (BP), diastolic BP, and baseline VA. Baseline values not carried forward for missing post-baseline data.
Odds Ratio (OR)
2.38
2-Sided
95
1.32
4.30
Superiority or Other
Secondary
Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Full Analysis Set (FAS)2 population:participants who had same treatment for 102 weeks (pegaptanib sodium or sham on/before Week 96) with baseline VA assessment, who met the following: had at least 1 post baseline VA within 2 years, before entry into the Year 3 open-label extension phase, or before withdrawing from the study prior to Week 102. LOCF.
Posted
Number
Participants
Baseline, Year 2
ID
Title
Description
OG000
0.3 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
OG001
Sham
Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
Secondary
Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
MITT1 population. LOCF.
Posted
Number
Participants
Baseline, Year 1
ID
Title
Description
OG000
0.3 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
OG001
Sham
Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
Units
Counts
Participants
Secondary
Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
FAS2 population. LOCF.
Posted
Number
Participants
Baseline, Year 2
ID
Title
Description
OG000
0.3 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
OG001
Sham
Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
Units
Counts
Participants
Secondary
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year
Retinopathy changes were monitored using fundus photography and fluorescein angiograph (FA) assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.
Evaluable participants from MITT1 population. Only 1 eye per participant was assessed in this study. LOCF.
Posted
Number
Eyes
Baseline, Year 1
ID
Title
Description
OG000
0.3 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
OG001
Sham
Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
Secondary
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year
Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.
Evaluable participants from MITT1 population. Only 1 eye per participant was assessed in this study. LOCF.
Posted
Number
Eyes
Baseline, Year 1
ID
Title
Description
OG000
0.3 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
OG001
Sham
Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
Secondary
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years
Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.
FAS2 population. Number of participants analyzed (N) = participants with evaluable data. Only 1 eye per participant was assessed in this study. LOCF.
Posted
Number
Eyes
Baseline, Year 2
ID
Title
Description
OG000
0.3 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
OG001
Sham
Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
Secondary
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years
Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.
FAS2 population. Number of participants analyzed (N) = participants with evaluable data. Only 1 eye per participant was assessed in this study. LOCF.
Posted
Number
Eyes
Baseline, Year 2
ID
Title
Description
OG000
0.3 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
OG001
Sham
Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
Secondary
Change From Baseline in Mean VA Score at 1 Year
Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.
MITT1 population. LOCF.
Posted
Mean
Standard Deviation
scores on a scale
Baseline, Year 1
ID
Title
Description
OG000
0.3 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
OG001
Sham
Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
Secondary
Change From Baseline in Mean VA Score at 2 Years
Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.
FAS2 population. LOCF.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline, Year 2
ID
Title
Description
OG000
0.3 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
OG001
Sham
Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
Secondary
Number of Participants Requiring Focal or Grid Laser Treatment During Year 1
Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation
MITT1 population
Posted
Number
Participants
1 year
ID
Title
Description
OG000
0.3 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
OG001
Sham
Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
Units
Counts
Participants
Secondary
Number of Participants Requiring Focal or Grid Laser Treatment During Year 2
Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation
FAS2 population
Posted
Number
Participants
2 years
ID
Title
Description
OG000
0.3 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
OG001
Sham
Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
Units
Counts
Participants
Time Frame
Not provided
Description
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
0.3 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks from baseline up to 2 years. Includes participants randomized to 0.3 mg pegaptanib sodium and participants randomized to lower doses of pegaptanib sodium who then converted to 0.3 mg pegaptanib sodium; for participants who converted to 0.3 mg pegaptanib sodium, only events that occurred while receiving 0.3 mg pegaptanib sodium treatment are reported.
42
174
110
174
EG001
0.03 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. Events reported for participants after start of treatment, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
4
22
15
22
EG002
0.003 mg Pegaptanib Sodium
Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. Events reported for participants after start of treatment, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
0
7
7
7
EG003
Sham
Standard of care and sham injection (the application of an empty barrel of a needleless syringe) from baseline up to Year 2. Events reported for participants after start of sham, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
35
143
100
143
EG004
0.3 mg Pegaptanib Sodium (Year 3)
Participants who were originally randomized to pegaptanib sodium, 0.3 mg who enrolled in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
4
46
11
46
EG005
Sham Conversion (Year 3)
Participants who were originally randomized to Sham who enrolled in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
6
54
10
54
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG0031 affected143 at risk
EG0040 affected46 at risk
EG0050 affected54 at risk
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Adrenocortical insufficiency acute
Endocrine disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 14.1
Non-systematic Assessment
EG0002 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 14.1
Non-systematic Assessment
EG0002 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Brain neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0011 affected22 at risk
EG0020 affected7 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Caridiac failure congestive
Cardiac disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0011 affected22 at risk
EG0020 affected7 at risk
EG003
Cataract
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 14.1
Non-systematic Assessment
EG0002 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Cervical myelopathy
Nervous system disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Colorectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 14.1
Non-systematic Assessment
EG0002 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Death
General disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Diabetic hyperglycaemic coma
Nervous system disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Diabetic retinal oedema
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Erythema nodosum
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Gangrene
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Glioblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Headache
Nervous system disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0011 affected22 at risk
EG0020 affected7 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Hypertension
Vascular disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Hypochromic anaemia
Blood and lymphatic system disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 14.1
Non-systematic Assessment
EG0002 affected174 at risk
EG0011 affected22 at risk
EG0020 affected7 at risk
EG003
Hypotension
Vascular disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Impaired healing
General disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA 14.1
Non-systematic Assessment
EG0002 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Iris neovascularisation
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Malignant hypertension
Vascular disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0011 affected22 at risk
EG0020 affected7 at risk
EG003
Metabolic disorder
Metabolism and nutrition disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Mitral valve stenosis
Cardiac disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Myocardial ishaemia
Cardiac disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0011 affected22 at risk
EG0020 affected7 at risk
EG003
Ocular hypertension
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Overweight
Metabolism and nutrition disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Polyp colorectal
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Renal artery stenosis
Renal and urinary disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0011 affected22 at risk
EG0020 affected7 at risk
EG003
Renal embolism
Renal and urinary disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0011 affected22 at risk
EG0020 affected7 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 14.1
Non-systematic Assessment
EG0002 affected174 at risk
EG0011 affected22 at risk
EG0020 affected7 at risk
EG003
Renal failure chronic
Renal and urinary disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Retroperitoneal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Troponin increased
Investigations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Umbilical hernia, obstructive
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Uterine prolapse
Reproductive system and breast disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Viral infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0003 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected174 at risk
EG0011 affected22 at risk
EG0020 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anterior chamber flare
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0021 affected7 at risk
EG0030 affected143 at risk
EG0040 affected46 at risk
EG0050 affected54 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0012 affected22 at risk
EG0020 affected7 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0012 affected22 at risk
EG0020 affected7 at risk
EG003
Cataract
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG00013 affected174 at risk
EG0012 affected22 at risk
EG0020 affected7 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG00034 affected174 at risk
EG0013 affected22 at risk
EG0021 affected7 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0009 affected174 at risk
EG0010 affected22 at risk
EG0021 affected7 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 14.1
Non-systematic Assessment
EG00011 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Diabetic retinal oedema
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG00018 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG00010 affected174 at risk
EG0010 affected22 at risk
EG0022 affected7 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0021 affected7 at risk
EG003
Eye irritation
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0021 affected7 at risk
EG003
Eye pain
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG00020 affected174 at risk
EG0015 affected22 at risk
EG0022 affected7 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0021 affected7 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0021 affected7 at risk
EG003
Hypertension
Vascular disorders
MedDRA 14.1
Non-systematic Assessment
EG00020 affected174 at risk
EG0013 affected22 at risk
EG0020 affected7 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA 14.1
Non-systematic Assessment
EG00029 affected174 at risk
EG0012 affected22 at risk
EG0022 affected7 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0009 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Macular oedema
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG00016 affected174 at risk
EG0012 affected22 at risk
EG0021 affected7 at risk
EG003
Myodesopsia
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG00010 affected174 at risk
EG0012 affected22 at risk
EG0020 affected7 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG00013 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0013 affected22 at risk
EG0020 affected7 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0012 affected22 at risk
EG0020 affected7 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG00020 affected174 at risk
EG0012 affected22 at risk
EG0020 affected7 at risk
EG003
Retinal aneurysm
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0021 affected7 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0021 affected7 at risk
EG003
Retinal exudates
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG00011 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG00010 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Retinal neovascularisation
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0022 affected7 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0021 affected7 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0011 affected22 at risk
EG0021 affected7 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG00016 affected174 at risk
EG0011 affected22 at risk
EG0022 affected7 at risk
EG003
Vitreous detachment
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected22 at risk
EG0021 affected7 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG00010 affected174 at risk
EG0010 affected22 at risk
EG0020 affected7 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D059039
Standard of Care
C495058
pegaptanib
Ancestor Terms
ID
Term
D019984
Quality Indicators, Health Care
D011787
Quality of Health Care
D006298
Health Services Administration
D017530
Health Care Quality, Access, and Evaluation
Browse Leaves
Not provided
Browse Branches
Not provided
4 subjects
Physician Decision
FG00011 subjects
FG0016 subjects
FG0024 subjects
FG00311 subjects
Withdrawal by Subject
FG0004 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
Other
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Lost to Follow-up or Patient non-comply
FG0004 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
2 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0035 subjects
Other
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Lost to Follow-up or Patient non-comply
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
57.3
± 10.1
BG00462.5± 9.7
11
BG0034
BG004139
Male
BG00086
BG00178
BG00211
BG0033
BG004178
Units
Counts
Participants
OG000133
OG001123
Title
Denominators
Categories
Title
Measurements
OG00051
OG00137
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.
0.1904
Odds Ratio (OR)
1.46
2-Sided
95
0.85
2.53
Superiority or Other
OG000
133
OG001127
Title
Denominators
Categories
Title
Measurements
OG00022
OG00113
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.
0.2466
Odds Ratio (OR)
1.57
2-Sided
95
0.74
3.34
Superiority or Other
OG000
133
OG001123
Title
Denominators
Categories
Title
Measurements
OG00030
OG00118
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.
0.1388
Odds Ratio (OR)
1.67
2-Sided
95
0.86
3.26
Superiority or Other
Units
Counts
Participants
OG00098
OG00197
Title
Denominators
Categories
Title
Measurements
OG0004
OG00112
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.
0.0468
Odds Ratio (OR)
0.27
2-Sided
95
0.07
0.99
Superiority or Other
Units
Counts
Participants
OG00098
OG00197
Title
Denominators
Categories
Title
Measurements
OG00010
OG0013
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.
0.1124
Odds Ratio (OR)
2.90
2-Sided
95
0.73
11.55
Superiority or Other
Units
Counts
Participants
OG000103
OG001102
Title
Denominators
Categories
Title
Measurements
OG0006
OG00113
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.
0.1788
Odds Ratio (OR)
0.48
2-Sided
95
0.16
1.42
Superiority or Other
Units
Counts
Participants
OG000103
OG001102
Title
Denominators
Categories
Title
Measurements
OG00017
OG0013
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.
0.0048
Odds Ratio (OR)
5.12
2-Sided
95
1.45
18.06
Superiority or Other
Units
Counts
Participants
OG000133
OG001127
Title
Denominators
Categories
Baseline
Title
Measurements
OG00057.0± 8.85
OG00157.5± 8.11
Change at 1 year
Title
Measurements
OG0005.2± 9.94
OG0011.2± 11.77
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.
0.0040
Least Squares (LS) Mean
3.90
2-Sided
95
1.25
6.54
Superiority or Other
Units
Counts
Participants
OG000133
OG001123
Title
Denominators
Categories
Baseline
Title
Measurements
OG00057.0± 8.85
OG00157.4± 8.20
Change at Year 2
Title
Measurements
OG0006.2± 10.58
OG0011.7± 11.68
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post baseline data.
0.0011
LS Mean
4.57
2-Sided
95
1.85
7.29
Superiority or Other
OG000133
OG001127
Title
Denominators
Categories
Title
Measurements
OG00031
OG00153
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.
0.0023
Odds Ratio (OR)
0.42
2-Sided
95
0.24
0.74
Superiority or Other
OG000133
OG001123
Title
Denominators
Categories
Title
Measurements
OG00034
OG00157
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.