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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Scott J. Westhouse, Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier:
NCT00473642
First received: May 14, 2007
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Age-Related Maculopathy
Choroidal Neovascularization
Drug: Ranibizumab
Drug: Verteporfin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Oklahoma State University Center for Health Sciences:

Primary Outcome Measures:
  • Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: May 2007
Study Completion Date: April 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Standard Fluence Photodynamic Therapy combined with ranibizumab
Drug: Ranibizumab
intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Other Name: Lucentis
Drug: Verteporfin
Verteporfin with standard fluence photodynamic therapy (50 J/cm2)
Other Name: 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 Name: Lucentis
Drug: Verteporfin
Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)
Other Name: Visudyne
Active Comparator: 3
Ranibizumab monotherapy
Drug: Ranibizumab
intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Other Name: Lucentis

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473642

Locations
United States, Oklahoma
Eagle Mountain Vision
Tulsa, Oklahoma, United States, 74132
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
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
  More Information

No publications provided

Responsible Party: Scott J. Westhouse, Ophthalmologist, Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT00473642     History of Changes
Other Study ID Numbers: 2007002
Study First Received: May 14, 2007
Results First Received: September 20, 2011
Last Updated: October 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Oklahoma State University Center for Health Sciences:
Ranibizumab
Lucentis
Verteporfin
Visudyne
Photodynamic therapy

Additional relevant MeSH terms:
Choroidal Neovascularization
Macular Degeneration
Neovascularization, Pathologic
Choroid Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Uveal Diseases
Verteporfin
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014