Lucentis Utilizing Visudyne (LUV Trial) Combination Therapy in the Treatment of Age-Related Macular Degeneration

Part of paid clinical trials in Houston, Texas.

Sponsor
David M. Brown, M.D.
Study ID
NCT00423189
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

The PDT/Lucentis trial will be a Phase IV comparative trial comparing the use of combination therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with exudative AMD.

Key Dates

First listed
Jan 18, 2007
Start date
Jan 31, 2007
Status verified
Feb 2016
Primary completion
Jan 31, 2009
Completion
Jan 31, 2009

Study Design

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

Arms

  • Active Comparator: Ranibizumab only
    drug - intravitreal ranibizumab
  • Experimental: 40% fluence PDT/procedure
    40% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab
  • Experimental: 20% fluence photodynamic therapy
    20% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab

Primary Outcome Measure

Best-corrected ETDRS Visual Acuity at 6 Months and 12 Months Only Time Points (Gain or Loss of >15 Letters at 12 Months) [ Time Frame: 1 Year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vitreoretinal ConsultantsHoustonTexas77030-

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