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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.

Pfizer logo

Pfizer

Status and phase

Completed
Phase 3
Phase 2

Conditions

Macular Edema Associated With Diabetes Mellitus

Treatments

Drug: Standard of Care
Drug: Macugen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00605280
A5751013
EOP1013H

Details and patient eligibility

About

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.

Enrollment

317 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

317 participants in 2 patient groups

Sham Control
Sham Comparator group
Treatment:
Drug: Standard of Care
Macugen
Experimental group
Treatment:
Drug: Macugen

Trial contacts and locations

73

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Data sourced from clinicaltrials.gov

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