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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts
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 - Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
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 - Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
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 - Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
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 - 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.
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 - 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.
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 - 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.
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 - 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.
Timepoint [7] 0 0
Baseline, Year 2
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Baseline, Year 1
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Baseline, Year 2
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
1 year
Secondary outcome [11] 0 0
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
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
Gender
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/Phase 3
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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.
Trial website
https://clinicaltrials.gov/show/NCT00605280
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

Summary results
Other publications