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

Overview

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.

Full Title of Study: “A Prospective Pilot Study of Reduced Fluence Photodynamic Therapy With Visudyne® (Verteporfin) in Combination With Lucentis™ (Ranibizumab) for the Treatment of Age-Related Macular Degeneration”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2009

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)

Arms, Groups and Cohorts

  • Experimental: 1
    • Standard Fluence Photodynamic Therapy combined with ranibizumab
  • Experimental: 2
    • Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
  • Active Comparator: 3
    • Ranibizumab monotherapy

Clinical Trial Outcome Measures

Primary Measures

  • Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months
    • Time Frame: 12 months
  • Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol
    • Time Frame: 12 months
    • Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study, the number of letters gained over the course of the study. In other words the baseline visual acuity in letters was subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.

Secondary Measures

  • Time to First Retreatment After Loading Doses, Average Number of Retreatments Over 12 Months, Central Macular Thickness on OCT, the Number of Recurrent CNV, the Number of Patients With Persistent CNV After the Mandatory Loading Doses.
    • Time Frame: 12 months

Participating in This Clinical Trial

Inclusion Criteria

1. Male or Female Patients > 50 years of age.

2. Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT.

3. Patient with BCVA of 20/40 to 20/320 in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. See definition of ETDRS charts.

4. If both eyes are eligible, only one eye will be evaluated in the study. The eye with lesser visual acuity will be selected as the study eye.

5. Patients must be able and willing to provide written informed consent.

Exclusion Criteria

1. Patients receiving prior treatment in the study eye with verteporfin, any focal laser photocoagulation, vitrectomy, or intravitreous injection of antiangiogenic medications, including triamcinolone, pegaptanib, bevacizumab, or ranibizumab.

2. Neovascular membrane from any other retinal disease such as myopic degeneration, histoplasmosis, retinal angiomatous proliferation, or other ocular inflammatory disease.

3. Choroidal neovascular membrane greater than 9 disc diameters in size.

4. Previous posterior vitrectomy in the study eye.

5. Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period.

6. Pregnant women or premenopausal women not using adequate contraception.

7. History of allergy to fluorescein, Visudyne, Lucentis.

8. Inability to comply with study or follow up procedures.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oklahoma State University Center for Health Sciences
  • Collaborator
    • Novartis
  • Provider of Information About this Clinical Study
    • Principal Investigator: Scott J. Westhouse, Ophthalmologist – Oklahoma State University Center for Health Sciences
  • Overall Official(s)
    • Scott J Westhouse, DO, Principal Investigator, Oklahoma State University Medical Center
    • Raymond Townsend, MD, Principal Investigator, Oklahoma State University Medical Center
    • John Saurino, DO, Principal Investigator, Oklahoma State University Medical Center

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