Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)

Part of paid clinical trials in Mobile, Alabama.

Sponsor
QLT Inc.
Study ID
NCT00492284
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • verteporfin — DRUG
    Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)
  • verteporfin — DRUG
    Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds)
  • ranibizumab — DRUG
    0.5 mg intravitreal injection
  • dexamethasone — DRUG
    0.5 mg intravitreal injection

Study Details

The objective of this study is to determine if combination therapy (reduced-fluence Visudyne followed by Lucentis \[within 2 hours\] or either of two regimens of reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy \[within 2 hours\]) reduces retreatment rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an acceptable safety profile.

Key Dates

Start date
Jul 31, 2007
Status verified
May 2011
Primary completion
May 31, 2009
Completion
May 31, 2010

Study Design

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

Arms

  • Experimental: 1/4 Fluence Triple Therapy
    Very low fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy \[within 2 hours\] administered on Day 0, and then as required every 2 months thereafter
  • Experimental: 1/2 Fluence Triple Therapy
    Reduced-fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy \[within 2 hours\] administered on Day 0, and then as required every 2 months thereafter
  • Experimental: 1/2 Fluence Double Therapy
    Reduced-fluence Visudyne followed by Lucentis double therapy \[within 2 hours\] administered on Day 0, and then as required every 2 months thereafter
  • Experimental: Ranibizumab
    Lucentis monotherapy administered on Day 0, Month 1 and Month 2, and then as required monthly thereafter

Primary Outcome Measure

Mean Number of Retreatments (Day 0 Excluded) [ Time Frame: Month 1 to Month 12 ]

Locations (21)

FacilityCityStateZIPSite coordinators
-MobileAlabama--
-PhoenixArizona--
Retina Centers, PCTucsonArizona--
-Beverly HillsCalifornia--
-CampbellCalifornia--
-Los AngelesCalifornia--
-PowayCalifornia--
-SacramentoCalifornia--
-TorranceCalifornia--
-Fort MyersFlorida--
-IndianapolisIndiana--
-DavenportIowa--
-MissoulaMontana--
-OmahaNebraska--
-PortsmouthNew Hampshire--
-PortlandOregon--
-PhiladelphiaPennsylvania--
-West MifflinPennsylvania--
-ArlingtonTexas--
-TempleTexas--
-SeattleWashington--

Find similar trials in Mobile, AL

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Retina Centers, PC· Tucson, AZ

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