Ranibizumab and Reduced Fluence PDT for AMD

Part of paid clinical trials in Santa Barbara, California.

Sponsor
Texas Retina Associates
Study ID
NCT00527475
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ranibizumab — DRUG
    0.5 mg. given as an intraocular injection
  • verteporfin — DRUG
    Standard dosage of 6 mgs. / meter2 of body surface area given intravenously.

Study Details

Single agent anti-VEGF therapies such as ranibizumab have shown great promise and have set the standard for visual outcomes in treating wet macular degeneration. However, they need to be administered frequently by intraocular injections with the attendant risk of endophthalmitis, lens damage, retinal detachment, and vitreous hemorrhage. The purpose of this trial is to see if using photodynamic therapy in combination with ranibizumab will decrease the number of treatments with ranibizumab.

Key Dates

Start date
May 31, 2007
Status verified
Nov 2025
Primary completion
Jan 31, 2010
Completion
Jan 31, 2010

Study Design

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

Arms

  • Active Comparator: Group I
    Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
  • Experimental: Group II
    Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.

Primary Outcome Measure

The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months. [ Time Frame: 1 year ]

Locations (3)

FacilityCityStateZIPSite coordinators
California Retina Consultants & Research FoundationSanta BarbaraCalifornia93103-
Associated Retinal ConsultantsAnn ArborMichigan49301-
Texas Retina AssociatesArlingtonTexas76012-

Find similar trials in Santa Barbara, CA

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
California Retina Consultants & Research Foundation· Santa Barbara, CAAssociated Retinal Consultants· Ann Arbor, MITexas Retina Associates· Arlington, TX

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