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Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration

NCT00473642 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-11-06

Study results available
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Summary

In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced fluence PDT combination therapy with ranibizumab. The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy. The information gained from this pilot study may prompt further definitive studies comparing the safety and efficacy of both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and ranibizumab monotherapy.

The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All patients will receive three consecutive monthly treatments with ranibizumab. Patients will be randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only ranibizumab. Patients randomized to group 2 will also receive one treatment with reduced fluence (50% fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also receive one treatment with standard fluence verteporfin PDT. All patients will also be evaluated for possible retreatment with ranibizumab and verteporfin PDT according to established criteria. Thirty patients will be recruited from one U.S. sites. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.

Conditions

  • Age-Related Maculopathy
  • Choroidal Neovascularization

Interventions

DRUG

Ranibizumab

intravitreal administered ranibizumab 0.5 mg in 0.05 mL

DRUG

Verteporfin

Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)

DRUG

Verteporfin

Verteporfin with standard fluence photodynamic therapy (50 J/cm2)

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Oklahoma State University Center for Health Sciences

    lead OTHER

Principal Investigators

  • Scott J Westhouse, DO · Oklahoma State University Medical Center

  • Raymond Townsend, MD · Oklahoma State University Medical Center

  • John Saurino, DO · Oklahoma State University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-05-31
Completion
2010-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00473642 on ClinicalTrials.gov