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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Macular Edema

Retinal Disease

Diabetic Mellitus

Treatments

Other: sham injection

Drug: pegaptanib sodium

Study type

Interventional

Funder types

Industry

Identifiers

NCT01100307

A5751034

Details and patient eligibility

About

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.

Full description

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

Enrollment

243 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type I, or Type II diabetic subjects
Subjects must have macular edema that involves the center field of the macula 3. Foveal thickness of at least 250 μm 4. Best corrected distance visual acuity in the study eye must be a letter score between 68 and 35 inclusive

Exclusion criteria

Eyes with prior panretinal photocoagulation (PRP) less than 4 months prior to baseline eyes in which PRP is needed now or is likely to be needed within the next 9 months
HbA1C level >12% or recent signs of uncontrolled diabetes
Atrophy/scarring/fibrosis involving the center of the macula, including evidence of laser treated atrophy