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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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ClinicalTrials.gov Identifier: NCT00605280
Recruitment Status : Completed
First Posted : January 31, 2008
Results First Posted : March 30, 2011
Last Update Posted : July 16, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Macular Edema Associated With Diabetes Mellitus Drug: Standard of Care Drug: Macugen Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : September 2005
Actual Primary Completion Date : November 2009
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Sham Comparator: Sham Control Drug: Standard of Care
Clinicians decision to use optional laser therapy.

Experimental: Macugen Drug: Macugen
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.




Primary Outcome Measures :
  1. Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year [ Time Frame: Baseline, Year 1 ]
    Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts


Secondary Outcome Measures :
  1. Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years [ Time Frame: Baseline, Year 2 ]
    Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts

  2. Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year [ Time Frame: Baseline, Year 1 ]
    Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts

  3. Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years [ Time Frame: Baseline, Year 2 ]
    Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts

  4. Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year [ Time Frame: Baseline, Year 1 ]
    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.

  5. Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year [ Time Frame: Baseline, Year 1 ]
    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.

  6. Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years [ Time Frame: Baseline, Year 2 ]
    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.

  7. Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years [ Time Frame: Baseline, Year 2 ]
    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.

  8. Change From Baseline in Mean VA Score at 1 Year [ Time Frame: Baseline, Year 1 ]
    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.

  9. Change From Baseline in Mean VA Score at 2 Years [ Time Frame: Baseline, Year 2 ]
    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.

  10. Number of Participants Requiring Focal or Grid Laser Treatment During Year 1 [ Time Frame: 1 year ]
    Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation

  11. Number of Participants Requiring Focal or Grid Laser Treatment During Year 2 [ Time Frame: 2 years ]
    Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • macular edema associated with diabetes
  • visual acuity between 20/50 and 20/200

Exclusion Criteria:

  • recent laser therapy in the eye
  • recent signs of uncontrolled diabetes
  • blood pressure worse than 160/100
  • severe cardiac disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00605280


  Show 73 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00605280     History of Changes
Obsolete Identifiers: NCT00148811
Other Study ID Numbers: A5751013
EOP1013H
First Posted: January 31, 2008    Key Record Dates
Results First Posted: March 30, 2011
Last Update Posted: July 16, 2012
Last Verified: July 2012

Keywords provided by Pfizer:
randomized sham-controlled multicenter macular edema

Additional relevant MeSH terms:
Diabetes Mellitus
Edema
Macular Edema
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases