Double-dose Ranibizumab for Polypoidal Choroidal Vasculopathy

Sun Yat-sen University

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Polypoidal Choroidal Vasculopathy

Treatments

Drug: Lucentis® (Raibizumab) regular-dose

Drug: Lucentis® (Raibizumab) double-dose

Study type

Interventional

Funder types

Other

Identifiers

NCT02769169

DREAM STUDY

Details and patient eligibility

About

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).

Full 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.

Enrollment

5 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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).