Lucentis KAV Study

Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Study ID
NCT01570608
Phase
PHASE3
Status
Completed

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    intravitreal injection 3 monthly injections thereafter as needed
  • Verteporfin — DRUG
    Verteporfin photodynamic therapy standard fluence

Study Details

Ranibizumab has been proven to be effective in large multicentre studies. However, the injections have to be repeated monthly. A combined therapy with the established photodynamic therapy might even be more effective, less intravitreal injections might be necessary due to a synergistic effect. The study will be conducted to explore whether intravitreal ranibizumab in monotherapy or in combination with verteporfin photodynamic therapy under a new time regime is an effective, safe and convenient treatment for patients with subfoveal Choroidal Neovascularisation (CNV) secondary to Age-Related Macular Degeneration (AMD).

Key Dates

Start date
Mar 31, 2007
Status verified
Apr 2012
Primary completion
Aug 31, 2011
Completion
Aug 31, 2011

Study Design

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

Arms

  • Active Comparator: monotherapy arm
    patients receiving 3 initial Ranibizumab injections, thereafter as needed
  • Active Comparator: combined treatment arm

Primary Outcome Measure

number of injections [ Time Frame: baseline-month 12 ]

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