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

Part of paid clinical trials in Tulsa, Oklahoma.

Sponsor
Oklahoma State University Center for Health Sciences
Study ID
NCT00473642
Phase
PHASE4
Status
Completed

Conditions

  • Age-Related Maculopathy
  • Choroidal Neovascularization

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    intravitreal administered ranibizumab 0.5 mg in 0.05 mL
  • Verteporfin — DRUG
    Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)
  • Verteporfin — DRUG
    Verteporfin with standard fluence photodynamic therapy (50 J/cm2)

Study Details

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.

Key Dates

Start date
May 31, 2007
Status verified
Nov 2020
Primary completion
May 31, 2009
Completion
Apr 30, 2010

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Eagle Mountain VisionTulsaOklahoma74132-

Find similar trials in Tulsa, OK

By research site
Eagle Mountain Vision· Tulsa, OK

Related Studies