Ranibizumab and Reduced Fluence PDT for AMD (RAP)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Ranibizumab and Reduced Fluence Photodynamic Therapy for Choroidal Neovascularization in Age Related Macular Degeneration|
- The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- The Number of Days to Retreatment. The Total Number of Treatments Given Over One Year. The Percentage of Patients With More Than a 15 Letter Increase in Vision at 12 Months. The Mean Change in Macular Volume as Measured by OCT at 3, 6, and 12 Months. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
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.
0.5 mg. given as an intraocular injection
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.
0.5 mg. given as an intraocular injectionDrug: verteporfin
Standard dosage of 6 mgs. / meter2 of body surface area given intravenously.
A randomized, prospective, multicenter trial will compare two groups of patients with subfoveal choroidal neovascularization secondary to AMD. One group 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. The other group 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. Re-treatment will be determined by the individual investigator based on visual acuity, retinal thickness as measured by optical coherence tomography (OCT), and fluorescein angiography. Visual acuity and OCT measurements will be performed by masked examiners.
|United States, California|
|California Retina Consultants & Research Foundation|
|Santa Barbara, California, United States, 93103|
|United States, Michigan|
|Associated Retinal Consultants|
|Ann Arbor, Michigan, United States, 49301|
|United States, Texas|
|Texas Retina Associates|
|Arlington, Texas, United States, 76012|
|Study Chair:||David Callanan, MD||Texas Retina Associates|