Macugen (Pegaptanib Sodium) Alone, Versus Macugen in Combination With PDT (Photodynamic Therapy) With Visudyne (Verteporfin) in Patients With Age-Related Macular Degeneration (AMD)

A Phase IIIb/IV Randomized, Double-Masked, Active Controlled, Dose-Ranging, Multi-Center Comparative Trial, in Parallel Groups, to Compare the Safety and Efficacy of Intravitreal Injections of Pegaptanib Sodium (Macugen) Given Every 6 Weeks for 102 Weeks, to Pegaptanib Sodium Plus Photodynamic Therapy (PDT) With Visudyne, in Patients With Exudative Age-Related Macular Degeneration (AMD)

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00134667

Enrollment

360

Registered

2005-08-25

Start date

2005-03-31

Completion date

2008-10-31

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

Age-Related Macular Degeneration

Keywords

AMD, Age-Related Macular Degeneration, Macular Degeneration, Macugen, Photodynamic Therapy, PDT, Visudyne, pegaptanib sodium, verteporfin, Predominantly Classic, Age-Related Macular Degeneration (AMD)

Brief summary

The purpose of the trial is to compare whether Macugen (pegaptanib sodium) in combination with PDT with Visudyne (verteporfin) is safe and effective in slowing down the leakage of fluid within the eye and thereby stabilizing or improving vision when compared to Macugen alone. Patients must be recently diagnosed with predominantly classic wet AMD and must be eligible for PDT.

Interventions

DRUGPhotodynamic Therapy (PDT) with Visudyne (verteporfin)

DRUGMacugen (pegaptanib 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 with predominantly classic lesion composition * Best corrected visual acuity in the study eye between 20/40 and 20/200

Exclusion criteria

* Any prior PDT with Visudyne to the study eye * Any previous AMD thermal laser therapy to the study eye

Countries

United States

Outcome results

None listed

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