Double-dose Ranibizumab for Polypoidal Choroidal Vasculopathy
- Conditions
- Polypoidal Choroidal Vasculopathy
- Interventions
- Registration Number
- NCT02769169
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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.
- 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%);
- Combine of hypertension and have poor blood pressure control (blood pressure ≥140/95 mmHg after regular antihypertensive drugs treatment);
- History of myocardial infarction or cerebral infarction in last 6 months;
- During gestation period or lactation period;
- Combine of confirmed systemic autoimmune disease or any uncontrollable clinical conditions (e.g. HIV, malignant tumor, active hepatitis, severe systemic disease, diseases need immediately surgical treatment).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description regular-dose Lucentis® (Raibizumab) regular-dose regular-dose Lucentis® (Raibizumab), 0.5mg, 3+prn double-dose Lucentis® (Raibizumab) double-dose double-dose Lucentis® (Raibizumab), 1mg, 3+prn
- Primary Outcome Measures
Name Time Method Number of participants who have at least 1 polyp resolution 6 months Number of participants who have at least 1 polyp resolution, assessed by Indocyanine angiography (ICGA) between baseline and Month 6
- Secondary Outcome Measures
Name Time Method change of best corrected visual acuity(BCVA) Baseline to 6 months Mean change in BCVA, from baseline to the end of 6 month. As assessed by changes of number of letters with the ETDRS (Early Treatment of Diabetic Retinopathy Study) chart
change of central foveal thickness Baseline to 6 months Mean change of central foveal thickness, from baseline to the end of 6 month. As assessed by optical coherence tomography scanning
Injection frequency Baseline to 6 months Average injection number(from baseline to the end of 6 month), assessed by the number of intravitreal injection from baseline to month 6
Safety analysis: number of adverse event 6 months Serious ocular adverse events in the study eye, including reduced VA, retinal hemorrhage, endophthalmitis, corneal edema, iridocyclitis, macular degeneration, retinal artery occlusion, retinal tear, retinal vein occlusion and vitreous floaters. Antiplatelet Trialists' Collaboration (APTC) arterial thromboembolic events (ATEs): including deaths (vascular or unknown cause), nonfatal myocardial infarction and hemorrhagic or ischemic nonfatal cerebrovascular accident. Serious adverse event of special interest, including ATE, bleeding/hemorrhage in central nervous system (CNS) or non-CNS, congestive heart failure, fistulae, gastrointestinal perforation, hypertension, venous thrombotic events and wound healing complications.
Trial Locations
- Locations (4)
The First People's Hospital of Xuzhou
🇨🇳Xuzhou, Jiangsu, China
Zhongshan Ophthalmic Center Guangzhou
🇨🇳Guangzhou, Guangdong, China
Dept. of Ophthalmology，Minhang hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Retina surgery department, Shenzhen Eye Hospital of Second Clinical Medical College of Jinan University
🇨🇳Shenzhen, Guangdong, China