Double-dose Ranibizumab for Polypoidal Choroidal Vasculopathy: A Prospective Randomized Multicenter Study
Overview
- Phase
- Phase 2
- Intervention
- Lucentis® (Raibizumab) double-dose
- Conditions
- Polypoidal Choroidal Vasculopathy
- Sponsor
- Sun Yat-sen University
- Enrollment
- 5
- Locations
- 4
- Primary Endpoint
- Number of participants who have at least 1 polyp resolution
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to determine whether double-dose Ranibizumab are effective to regress the polyps and benefit to the visual outcome in the polypoidal choroidal vasculopathy (PCV).
Detailed Description
Recently, it's reported that intravitreal high dose Lucentis®（Ranibizumab） could benefit to both regression of the polyps and the relief of macular edema in PCV patients. Since it was a single arm prospective study with a relatively small sample size, randomized clinical trials were needed to confirm the efficacy of high dose Ranibizumab in PCV treatment. In this study, the investigator will compare the efficacy of double-dose (1mg, 3+prn) Raibizumab with regular dose (0.5mg, 3+prn) for PCV treatment.
Investigators
Lin Lu
MD, PhD，Zhongshan Ophthalmic Center
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 50 years and ≤80;
- •Active PCV confirmed by ICGA+FFA (Indocyanine green angiography + fundus fluorescein angiography);
- •At least one distinguishable polyp was shown in ICGA;
- •BCVA between 24 to 73 letters with ETDRS chart (Early Treatment of Diabetic Retinopathty Study);
- •The greatest linear dimension of the lesion \<5400μm.
Exclusion Criteria
- •Previously received treatment of laser retina photocoagulation, transpupillary thermotherapy, pneumatic displacement of subretinal blood or any investigational treatment;
- •Previous photodynamic therapy or anti-Vegf treatment within 6 months in study eye
- •Previously received treatment of photodynamic treatment within 1 month, or any anti-vascular endothelial growth factor (VEGF) intraocular injection in 3 months in the fellow eye;
- •Combine of current vitreous hemorrhage or extensive subretinal hemorrhage (lesion area \>30mm2);
- •A history of angioid streaks, presumed ocular histoplasmosis syndrome or pathologic myopia;
- •Experienced retinal pigmental epithelium (RPE) tear, retinal detachment, macular hole or uncontrolled glaucoma;
- •Undergone intraocular surgery (except uncomplicated cataract extraction with intraocular lens implantation);
- •Cataract extraction with intraocular lens implantation within 60 days;
- •Combine of cataract that could require medical or surgical intervention during 12 months;
- •Combine of diabetes mellitus and have poor glucose control (Haemoglobin A1c (HbA1c) \>8%);
Arms & Interventions
double-dose
double-dose Lucentis® (Raibizumab), 1mg, 3+prn
Intervention: Lucentis® (Raibizumab) double-dose
regular-dose
regular-dose Lucentis® (Raibizumab), 0.5mg, 3+prn
Intervention: Lucentis® (Raibizumab) regular-dose
Outcomes
Primary Outcomes
Number of participants who have at least 1 polyp resolution
Time Frame: 6 months
Number of participants who have at least 1 polyp resolution, assessed by Indocyanine angiography (ICGA) between baseline and Month 6
Secondary Outcomes
- change of best corrected visual acuity(BCVA)(Baseline to 6 months)
- change of central foveal thickness(Baseline to 6 months)
- Injection frequency(Baseline to 6 months)
- Safety analysis: number of adverse event(6 months)