Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab Versus Lucentis Monotherapy to Treat Age-Related Macular Degeneration

Part of paid clinical trials in Castro Valley, California.

Sponsor
Bay Area Retina Associates
Study ID
NCT00390208
Phase
PHASE2
Status
Completed

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

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

Interventions

  • ranibizumab, dexamethasone and verteporfin — DRUG
    One 500 microgram dose (0.05cc) intravitreal dexamethasone (10 mg/ml vial) in combination with Visudyne Photodynamic Therapy and 0.5 mg intravitreal Ranibizumab injection on the same day.
  • Ranibizumab — DRUG
    One 0.5 mg intravitreal Ranibizumab injection

Study Details

The purpose of this study is to compare triple therapy using Photodynamic therapy, intravitreal Dexamethasone and intravitreal Ranibizumab injections versus monotherapy with intravitreal Ranibizumab alone for the treatment of Age-Related Macular Degeneration.

Key Dates

Start date
Aug 31, 2006
Status verified
May 2010
Primary completion
Dec 31, 2008
Completion
Dec 31, 2009

Study Design

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

Arms

  • Other: Group 1
    Combination triple therapy of Lucentis, Dexamethasone and Visudyne Therapy
  • Other: Group 2
    Monotherapy: One 0.5 mg intravitreal Ranibizumab injection

Primary Outcome Measure

Visual Acuity: Change in visual acuity by 15 or more ETDRS letters at 6 and 12 months. Non-inferiority as compared to the triple therapy arm will serve to determine efficacy for the purposes of this pilot trial. [ Time Frame: one year ]

Locations (4)

FacilityCityStateZIPSite coordinators
Bay Area Retina AssociatesCastro ValleyCalifornia94546-
Bay Area Retina AssociatesWalnut CreekCalifornia94598-
Georgia RetinaRiverdaleGeorgia30274-
Retina Vitreous AssociatesToledoOhio43608-

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By research site
Bay Area Retina Associates· Castro Valley, CABay Area Retina Associates· Walnut Creek, CAGeorgia Retina· Riverdale, GARetina Vitreous Associates· Toledo, OH

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