The PDT/Lucentis trial will be a Phase IV comparative trial comparing the use of combination therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with exudative AMD.
The PDT/Lucentis trial will be a Phase IV comparative trial comparing the use of combination therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with exudative AMD. Patients will be randomized to one of three groups. All patients will receive three consecutive monthly treatments with ITV ranibizumab. Patients randomized to group I will receive only ITV ranibizumab. Patients randomized to group II will also receive one treatment with reduced fluence (20% fluence) verteporfin PDT at day 0. Patients randomized to group III will also receive one treatment with reduced fluence (40% fluence) vPDT. All patients will also be evaluated for possible retreatment with ranibizumab according to established criteria. Thirty patients (ten per group) will be recruited from one U.S. sites in a 6-month period. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
as needed, one intravitreal injection of 0.50mg ranibizumab
as needed, one intravitreal injection of 0.50mg ranibizumab
Vitreoretinal Consultants
Houston, Texas, United States
Best-corrected ETDRS Visual Acuity at 6 Months and 12 Months Only Time Points (Gain or Loss of >15 Letters at 12 Months)
Visual Acuity was measured by ETDRS by certified refractionists in certified lanes at 12 months. Visual Acuity was not measured by ETDRS at 6 months.
Time frame: 1 Year
Number of Intravitreal Injections With Ranibizumab Needed by Patients at 12 Months
Number of intravitreal injections with ranibizumab needed by patients at 12 months was not determined due to lack of efficacy.
Time frame: 1 Year
OCT 3 Macular Thickness Improvement (Baseline-1month, 2months, 3months, 6months &12 Months)
OCT 3 macular thickness improvement at Baseline-1month, 2months, 3months, 6months \&12 months was not determined due to lack of efficacy.
Time frame: 1 Year
Choroidal Perfusion as Assessed by ICG Angiography at 1, 2, 3, 6, and 12 Months
Choroidal perfusion as assessed by ICG angiography at 1, 2, 3, 6, and 12 months was not determined due to lack of efficacy
Time frame: 1 Year
Safety of Combination Therapy With Verteporfin PDT and ITV Ranibizumab
Safety of combination therapy with verteporfin PDT and ITV ranibizumab was not determined due to lack of efficacy.
Time frame: 1 Year
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