Double-dose Ranibizumab for Polypoidal Choroidal Vasculopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2018-12-15

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Polypoidal Choroidal Vasculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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double-dose

double-dose

Lucentis® (Raibizumab), 1mg, 3+prn

Group Type EXPERIMENTAL

Lucentis® (Raibizumab) double-dose

Intervention Type DRUG

Give patients 1 injection per month at the beginning 3 months. Give patients additional injection as needed. One injection contains 1mg of Lucentis® (Raibizumab). Intervention 'double-dose: Ranibizumab 1mg, 3 injection plus prn' has not been included in any Arm/Group Descriptions.

regular-dose

regular-dose

Lucentis® (Raibizumab), 0.5mg, 3+prn

Group Type ACTIVE_COMPARATOR

Lucentis® (Raibizumab) regular-dose

Intervention Type DRUG

Give patients 1 injection per month at the beginning 3 months. Give patients additional injection as needed. One injection contains 0.5mg of Lucentis® (Raibizumab). regular-dose: Ranibizumab 0.5mg, 3 injection plus prn

Interventions

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Lucentis® (Raibizumab) double-dose

Give patients 1 injection per month at the beginning 3 months. Give patients additional injection as needed. One injection contains 1mg of Lucentis® (Raibizumab). Intervention 'double-dose: Ranibizumab 1mg, 3 injection plus prn' has not been included in any Arm/Group Descriptions.

Intervention Type DRUG

Lucentis® (Raibizumab) regular-dose

Give patients 1 injection per month at the beginning 3 months. Give patients additional injection as needed. One injection contains 0.5mg of Lucentis® (Raibizumab). regular-dose: Ranibizumab 0.5mg, 3 injection plus prn

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No