A Clinical Trial to Explore the Safety and Efficacy of Three Different Doses of Pegaptanib Sodium in Patients With Wet Age-Related Macular Degeneration (AMD)

An Exploratory Randomized, Double-Masked, Multi-Center Comparative Trial, in Parallel Groups, to Explore the Safety and Efficacy of Three Different Doses of Intravitreous Injections of Pegaptanib Sodium (Anti-VEGF Pegylated Aptamer) Given Every 6 Weeks for 102 Weeks, in Patients With Subfoveal Neovascular Age-Related Macular Degeneration (AMD)

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00312351

Enrollment

262

Registered

2006-04-10

Start date

2006-04-30

Completion date

2006-11-30

Last updated

2007-01-15

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

Conditions

Macular Degeneration

Keywords

AMD, Age-Related Macular Degeneration, Macular Degeneration, Macugen, pegaptanib sodium, ERG, specular microscopy, Age-Related Mcular Degeneration (AMD)

Brief summary

The purpose of this trial is to compare the ability of three different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or improving vision in patients with wet AMD. The study will also examine the effects of pegaptanib sodium on the cornea and sensory retina of patients with wet AMD.

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

* Subjects of either gender, aged 50 years or greater. * Subfoveal choroidal neovascularization (CNV) due to AMD. * Best corrected visual acuity in the study eye between 20/40 and 20/320. * Normal electroretinogram, and corneal endothelial cell density of 1500 cells/mm2 or more.

Exclusion criteria

* Any prior photodynamic therapy (PDT) with Visudyne or thermal laser to the study eye.

Countries

United States

Outcome results

None listed

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