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

Clinical Study Of EYE001 In Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150202

Enrollment

Registered

2005-09-08

Start date

2004-07-31

Completion date

2006-10-31

Last updated

2007-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

Brief summary

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.

Interventions

DRUGpegaptanib sodium

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Wet AMD, Visual Acuity from 20/320 to 20/40

Exclusion criteria

* Diabetic retinopathy, laser coagulation history

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026