NCT01100307

A Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema

A Phase 3, Randomized, Controlled, Double-Masked, Multi-Center, Comparative, In Parallel Groups (For 24 Weeks), To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium, With Sham Injections, And Open Study (For 30 Weeks) To Confirm The Safety Of 0.3 MG Pegaptanib Sodium In Subjects With Diabetic Macular Edema (DME)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular edema.

Detailed description

During the study, an issue was reported concerning proper maintenance of treatment masking (See Result: Limitations and Caveats)

Conditions

• Macular Edema
• Diabetic Mellitus
• Retinal Disease

Interventions

Type	Name	Description
DRUG	pegaptanib sodium	Intravitreal injection of 0.3 mg every 6 weeks
OTHER	sham injection	sham injection every 6 weeks

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-04-08
• Last updated: 2013-08-23
• Results posted: 2013-07-15

Locations

43 sites across 1 country: Japan