Photodynamic and Pharmacologic Treatment of CNV

Sponsor
Mid-Atlantic Retina Consultations, Inc.
Study ID
NCT00570193
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • verteporfin (Visudyne) — DRUG
    Verteporfin (Visudyne) 6 mg/m2 at 300mW/cm2 given on week O and then at week 5, given as indicated per protocol; ranibizumab (Lucentis) 0.3 mg given at week 1
  • ranibizumab (Lucentis) — DRUG
    ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33\&37 per study protocol

Study Details

The goal of this pilot study is to validate the use of the combination of Lucentis (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a volumetric analysis of the CNV lesion to determine disease activity, response to therapy, and as a tool for determining the need for retreatment.

Key Dates

Start date
Dec 31, 2006
Status verified
Jul 2012
Primary completion
Jun 30, 2011
Completion
Jun 30, 2011

Study Design

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

Arms

  • Experimental: I
    Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis)
  • Experimental: II
    Treatment with ranibizumab (Lucentis)

Primary Outcome Measure

Visual change [ Time Frame: 18 months ]

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