This is a one-year, randomized, single-center open-label pilot study of the safety and efficacy of combination ranibizumab and PDT for AMD. Eligible subjects will be randomized to either combination treatment, or ranibizumab monotherapy (control group). The combination treatment group will receive ranibizumab, followed 1 week later by verteporfin PDT. Additional treatments will be based on evidence of active disease (subretinal fluid on OCT or leakage on FA): repeat ranibizumab injections will be allowed monthly, and repeat PDT will be allowed every 3 months. The control group will receive "standard-of-care" ranibizumab monotherapy according to the protocol currently followed by most retinal specialists. Ranibizumab injections will be given at baseline and months one and two. Additional injections will be given at each monthly visit at which there is evidence of active disease by visual acuity, OCT and FA criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Ranibizumab 0.5 mg
Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)
Illinois Retina Associates
Oak Park, Illinois, United States
To determine whether combination treatment can maintain or improve visual acuity within 3 lines of baseline visual acuity.
Time frame: 1 year
Determination of whether combination treatment can minimize the number of re-treatments required to stabilize vision.
Time frame: 1 year
Determination of change in visual acuity from baseline.
Time frame: 1 year
Determination of change in retinal thickness by optical coherence tomography (OCT).
Time frame: 1 year
Determination of change in angiographic leakage from CNV.
Time frame: 1 year
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