Clinical Study Of EYE001 For Wet-Type AMD (Age-Related Macular Degeneration)

Pfizer90 enrolled

Overview

This study will examine the efficacy and safety of pegaptanib sodium in Japanese patients with wet-type AMD, in order to establish that there is no large difference in the efficacy and the safety of the drug between Western and Japanese patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Macular Degeneration

Interventions

pegaptanib sodiumDRUG

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Wet AMD, Visual Acuity from 20/320 to 20/40 Exclusion Criteria: * Diabetic retinopathy, laser coagulation history

Locations (14)

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Pfizer Investigational Site

Urayasu-shi, Chiba, Japan

Pfizer Investigational Site

Tokyo, Chiyoda-ku, Japan

Outcomes

Primary Outcomes

Visual aquity change from the baseline to 54 weeks after the first treatment is expected to be similar to that seen in the Western studies.

Secondary Outcomes

Safety profile of pegaptanib including side effects and lab test from the baseline to 54 weeks after the first treatment. Blood concentration of the drug from the baseline to 54 weeks after the irst treatment.

Data from ClinicalTrials.gov

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