The Ranibizumab Plus Transpupillary Thermotherapy for Neovascular Age-Related Macular Degeneration (AMD) Study

Sponsor
Anders Kvanta
Study ID
NCT00599222
Phase
PHASE3
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • ranibizumab — BIOLOGICAL
    0.5 mg intravitreal injection
  • TTT — PROCEDURE
    Transpupillary thermotherapy (TTT)
  • Sham TTT — PROCEDURE
    Sham Transpupillary thermotherapy (TTT)

Study Details

Neovascular age-related macular degeneration (AMD) is the leading cause of severe vision loss in the Western world. Intravitreal ranibizumab has recently become the treatment of choice for neovascular (AMD). Limitations to ranibizumab however include the high cost for the drug and the need for frequent intravitreal re-injections. The investigators' hypothesis is that when ranibizumab is combined with transpupillary thermotherapy (TTT) the number of necessary retreatments with Lucentis will be significantly reduced as compared to ranibizumab alone.

Key Dates

First listed
Jan 23, 2008
Start date
Feb 29, 2008
Status verified
Nov 2011
Primary completion
Nov 30, 2009
Completion
Feb 28, 2010

Study Design

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

Arms

  • Active Comparator: TTT
    TTT is given every three months
  • Sham Comparator: Sham TTT
    Sham TTT is given every three months

Primary Outcome Measure

The proportion of patients that will need 5 injections (loading phase excluded) or less with ranibizumab [ Time Frame: 1 year ]

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