Double-dose Ranibizumab for Polypoidal Choroidal Vasculopathy

• Status: Terminated
• Trial end date: 2018-12-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Ranibizumab

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%);

• 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).