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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.
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.
Secondary ID [1] 0 0
EOP1013H
Secondary ID [2] 0 0
A5751013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Edema Associated With Diabetes Mellitus 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Greater Than or Equal to =10 Letter (or 2 Line) Improvement in Vision at 1 Year
Timepoint [1] 0 0
Baseline, Year 1
Secondary outcome [1] 0 0
Number of Participants With a = 10 Letter (or 2 Line) Improvement in Vision at 2 Years
Timepoint [1] 0 0
Baseline, Year 2
Secondary outcome [2] 0 0
Number of Participants With a = 15 Letter Improvement in Vision at 1 Year
Timepoint [2] 0 0
Baseline, Year 1
Secondary outcome [3] 0 0
Number of Participants With a = 15 Letter Improvement in Vision at 2 Years
Timepoint [3] 0 0
Baseline, Year 2
Secondary outcome [4] 0 0
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year
Timepoint [4] 0 0
Baseline, Year 1
Secondary outcome [5] 0 0
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year
Timepoint [5] 0 0
Baseline, Year 1
Secondary outcome [6] 0 0
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years
Timepoint [6] 0 0
Baseline, Year 2
Secondary outcome [7] 0 0
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years
Timepoint [7] 0 0
Baseline, Year 2
Secondary outcome [8] 0 0
Change From Baseline in Mean VA Score at 1 Year
Timepoint [8] 0 0
Baseline, Year 1
Secondary outcome [9] 0 0
Change From Baseline in Mean VA Score at 2 Years
Timepoint [9] 0 0
Baseline, Year 2
Secondary outcome [10] 0 0
Number of Participants Requiring Focal or Grid Laser Treatment During Year 1
Timepoint [10] 0 0
1 year
Secondary outcome [11] 0 0
Number of Participants Requiring Focal or Grid Laser Treatment During Year 2
Timepoint [11] 0 0
2 years

Eligibility
Key inclusion criteria
* macular edema associated with diabetes
* visual acuity between 20/50 and 20/200
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* recent laser therapy in the eye
* recent signs of uncontrolled diabetes
* blood pressure worse than 160/100
* severe cardiac disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
317
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [2] 0 0
Pfizer Investigational Site - East Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Austria
State/province [18] 0 0
Innsbruck
Country [19] 0 0
Austria
State/province [19] 0 0
Wien
Country [20] 0 0
Brazil
State/province [20] 0 0
GO
Country [21] 0 0
Brazil
State/province [21] 0 0
Porto Alegre
Country [22] 0 0
Brazil
State/province [22] 0 0
Sao Paolo
Country [23] 0 0
Brazil
State/province [23] 0 0
Sao Paulo
Country [24] 0 0
Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
Colombia
State/province [26] 0 0
Bogota
Country [27] 0 0
Czechia
State/province [27] 0 0
Brno
Country [28] 0 0
Czechia
State/province [28] 0 0
Hradec Kralove
Country [29] 0 0
Czechia
State/province [29] 0 0
Olomouc
Country [30] 0 0
Czechia
State/province [30] 0 0
Praha 4
Country [31] 0 0
Czechia
State/province [31] 0 0
Praha 6
Country [32] 0 0
Denmark
State/province [32] 0 0
Glostrup
Country [33] 0 0
France
State/province [33] 0 0
Cedex
Country [34] 0 0
France
State/province [34] 0 0
Clermont
Country [35] 0 0
France
State/province [35] 0 0
Lyon
Country [36] 0 0
France
State/province [36] 0 0
Marseille Cedex 5
Country [37] 0 0
France
State/province [37] 0 0
Marseille
Country [38] 0 0
France
State/province [38] 0 0
Marsielle
Country [39] 0 0
France
State/province [39] 0 0
Nancy Cedex
Country [40] 0 0
France
State/province [40] 0 0
Paris Cedex 12
Country [41] 0 0
Germany
State/province [41] 0 0
Bonn
Country [42] 0 0
Germany
State/province [42] 0 0
Duesseldorf
Country [43] 0 0
Germany
State/province [43] 0 0
Heidelberg
Country [44] 0 0
Germany
State/province [44] 0 0
Leipzig
Country [45] 0 0
Germany
State/province [45] 0 0
Muenster
Country [46] 0 0
Germany
State/province [46] 0 0
Tuebingen
Country [47] 0 0
Greece
State/province [47] 0 0
Athens
Country [48] 0 0
India
State/province [48] 0 0
Ahmedabad
Country [49] 0 0
India
State/province [49] 0 0
Bangalore
Country [50] 0 0
India
State/province [50] 0 0
Hyderabad
Country [51] 0 0
India
State/province [51] 0 0
New Delhi
Country [52] 0 0
Italy
State/province [52] 0 0
Firenze
Country [53] 0 0
Italy
State/province [53] 0 0
Milano
Country [54] 0 0
Italy
State/province [54] 0 0
Udine
Country [55] 0 0
Netherlands
State/province [55] 0 0
Nijmegen
Country [56] 0 0
Portugal
State/province [56] 0 0
Coimbra
Country [57] 0 0
South Africa
State/province [57] 0 0
Bloemfontein
Country [58] 0 0
Switzerland
State/province [58] 0 0
Bern
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Newcastle Upon Tyne
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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