The primary objective of this study is to determine the safety \& efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to age related macular degeneration.
This study will be a phase I/II open label interventional case series. Twenty patients with retinal angiomatous proliferation will be randomized to receive intravitreal ranibizumab at a dose of 0.3mg/0.05 ml or 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 12 months. Patients will be followed for a complete 12-month treatment course.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
0.3mg/0.05 ml or 0.5mg/0.05 ml
0.3mg/0.05 ml or 0.5mg/0.05 ml
0.3mg/0.05 ml intravitreally
National Retina Institute
Chevy Chase, Maryland, United States
National Retina Institute
Towson, Maryland, United States
Proportion of patients with stabilization of visual acuity, vision loss of < 15 letters
Time frame: 2 years
Proportion of subjects who gain at least 15 letters in the best corrected visual acuity score at 6 and 12 months compared to baseline
Time frame: 12 months
Incidence and severity of ocular adverse events
Time frame: 12 months
Incidence and severity of non-ocular adverse events
Time frame: 12 months
Changes in vital signs
Time frame: 12 months
Assess the systemic and local safety of ranibizumab (0.3mg or 0.5mg) in patients with RAP lesions
Time frame: 12 months
Assess the impact of ranibizumab (0.3mg or 0.5mg) on time to improvement in retinal thickness by OCT
Time frame: 2 years
Assess the impact of ranibizumab (0.3mg or 0.5 mg) on leakage from RAP lesions by Fluorescein angiography
Time frame: 2 years
Static / high speed ICG appearance to assess the impact of ranibizumab (0.3mg or 0.5mg) on persistence / recurrence of RAP lesion and monitor for development of retinal-choroidal anastomoses
Time frame: 2 years
Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of retinal-choroidal anastomoses as determined on clinical examination and high speed ICG
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0.5mg/0.05 ml
Time frame: 2 years
Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of subretinal fibrosis as determined by clinical examination
Time frame: 2 years