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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00605280
Registration number
NCT00605280
Ethics application status
Date submitted
18/01/2008
Date registered
31/01/2008
Date last updated
16/11/2018
Titles & IDs
Public 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.
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Scientific 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.
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Secondary ID [1]
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EOP1013H
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Secondary ID [2]
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A5751013
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Macular Edema Associated With Diabetes Mellitus
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Standard of Care
Treatment: Drugs - Macugen
Sham comparator: Sham Control -
Experimental: Macugen -
Treatment: Drugs: Standard of Care
Clinicians decision to use optional laser therapy.
Treatment: Drugs: Macugen
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Greater Than or Equal to =10 Letter (or 2 Line) Improvement in Vision at 1 Year
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Assessment method [1]
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Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts
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Timepoint [1]
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Baseline, Year 1
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Secondary outcome [1]
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Number of Participants With a = 10 Letter (or 2 Line) Improvement in Vision at 2 Years
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Assessment method [1]
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Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
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Timepoint [1]
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Baseline, Year 2
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Secondary outcome [2]
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Number of Participants With a = 15 Letter Improvement in Vision at 1 Year
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Assessment method [2]
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Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
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Timepoint [2]
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Baseline, Year 1
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Secondary outcome [3]
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Number of Participants With a = 15 Letter Improvement in Vision at 2 Years
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Assessment method [3]
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Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
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Timepoint [3]
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Baseline, Year 2
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Secondary outcome [4]
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Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Year 1
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Secondary outcome [5]
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Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, Year 1
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Secondary outcome [6]
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Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline, Year 2
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Secondary outcome [7]
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Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline, Year 2
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Secondary outcome [8]
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Change From Baseline in Mean VA Score at 1 Year
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline, Year 1
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Secondary outcome [9]
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Change From Baseline in Mean VA Score at 2 Years
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, Year 2
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Secondary outcome [10]
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Number of Participants Requiring Focal or Grid Laser Treatment During Year 1
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Assessment method [10]
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Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation
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Timepoint [10]
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1 year
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Secondary outcome [11]
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Number of Participants Requiring Focal or Grid Laser Treatment During Year 2
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Assessment method [11]
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Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation
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Timepoint [11]
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2 years
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Eligibility
Key inclusion criteria
* macular edema associated with diabetes
* visual acuity between 20/50 and 20/200
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* recent laser therapy in the eye
* recent signs of uncontrolled diabetes
* blood pressure worse than 160/100
* severe cardiac disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2011
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Sample size
Target
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Accrual to date
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Final
317
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Pfizer Investigational Site - Westmead
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Recruitment hospital [2]
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Pfizer Investigational Site - East Melbourne
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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- East Melbourne
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Austria
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Innsbruck
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Austria
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Wien
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GO
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New Delhi
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Udine
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Coimbra
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Bern
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Newcastle Upon Tyne
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00605280
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00605280
Download to PDF