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

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

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.

Study Overview

• Status: Completed
• Conditions: Choroidal Neovascularization; Age-Related Maculopathy
• Intervention / Treatment: Drug: Ranibizumab; Drug: Verteporfin; Drug: Verteporfin

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74132
      • Eagle Mountain Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Standard Fluence Photodynamic Therapy combined with ranibizumab	Drug: Ranibizumab; intravitreal administered ranibizumab 0.5 mg in 0.05 mL; Other Names: Lucentis; Drug: Verteporfin; Verteporfin with 50% fluence photodynamic therapy (25 J/cm2); Other Names: Visudyne; Drug: Verteporfin; Verteporfin with standard fluence photodynamic therapy (50 J/cm2); Other Names: Visudyne
Experimental: 2; Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab	Drug: Ranibizumab; intravitreal administered ranibizumab 0.5 mg in 0.05 mL; Other Names: Lucentis; Drug: Verteporfin; Verteporfin with 50% fluence photodynamic therapy (25 J/cm2); Other Names: Visudyne; Drug: Verteporfin; Verteporfin with standard fluence photodynamic therapy (50 J/cm2); Other Names: Visudyne
Active Comparator: 3; Ranibizumab monotherapy	Drug: Ranibizumab; intravitreal administered ranibizumab 0.5 mg in 0.05 mL; Other Names: Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in BCVA of ETDRS Letters From Baseline at 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 baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.	12 months
Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol	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 baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to First Retreatment After Loading Doses	12 months
Average Number of PDT Retreatments Over 12 Months	12 months
Central Macular Thickness Reduction on OCT	12 months
Average Number of Ranibizumab Retreatments Over 12 Months	12 months

Collaborators and Investigators

• Sponsor: Oklahoma State University Center for Health Sciences
• Collaborators: Novartis
• Investigators: Principal Investigator: Scott J Westhouse, DO, Oklahoma State University Medical Center; Principal Investigator: Raymond Townsend, MD, Oklahoma State University Medical Center; Principal Investigator: John Saurino, DO, Oklahoma State University Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: May 14, 2007
• First Submitted That Met QC Criteria: May 14, 2007
• First Posted (Estimate): May 15, 2007

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Ranibizumab; Lucentis; Photodynamic therapy; Visudyne; Verteporfin
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Degeneration; Retinal Diseases; Uveal Diseases; Choroid Diseases; Metaplasia; Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Photosensitizing Agents; Dermatologic Agents; Ranibizumab; Verteporfin
• Other Study ID Numbers: 2007002