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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

Last updated on February 18, 2019

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Study Location
Nagoya City University Hospital
Nagoya, Aichi, Japan
Contact
1-800-718-1021
ClinicalTrials.gov_Inqui[email protected]
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Macular Edema, Diabetic Mellitus, Retinal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT01100307
Pfizer
Completed
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

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