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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00605280
First received: January 18, 2008
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Macular Edema Associated With Diabetes Mellitus
Drug: Standard of Care
Drug: Macugen
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years [ Time Frame: Baseline, Year 2 ] [ Designated as safety issue: No ]
    Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts

  • Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year [ Time Frame: Baseline, Year 1 ] [ Designated as safety issue: No ]
    Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts

  • Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years [ Time Frame: Baseline, Year 2 ] [ Designated as safety issue: No ]
    Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts

  • Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year [ Time Frame: Baseline, Year 1 ] [ Designated as safety issue: No ]
    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.

  • Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year [ Time Frame: Baseline, Year 1 ] [ Designated as safety issue: No ]
    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.

  • Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years [ Time Frame: Baseline, Year 2 ] [ Designated as safety issue: No ]
    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.

  • Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years [ Time Frame: Baseline, Year 2 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Mean VA Score at 1 Year [ Time Frame: Baseline, Year 1 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Mean VA Score at 2 Years [ Time Frame: Baseline, Year 2 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Requiring Focal or Grid Laser Treatment During Year 1 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation

  • Number of Participants Requiring Focal or Grid Laser Treatment During Year 2 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation


Enrollment: 317
Study Start Date: September 2005
Study Completion Date: July 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605280

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00605280     History of Changes
Obsolete Identifiers: NCT00148811
Other Study ID Numbers: A5751013, EOP1013H
Study First Received: January 18, 2008
Results First Received: November 18, 2010
Last Updated: July 5, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 31, 2014