Double-dose Ranibizumab for Polypoidal Choroidal Vasculopathy

Polypoidal Choroidal Vasculopathy Clinical Trial

Official title:

Double-dose Ranibizumab for Polypoidal Choroidal Vasculopathy: A Prospective Randomized Multicenter Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02769169
• Other study ID #: DREAM STUDY
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: August 1, 2018
• Est. completion date: December 15, 2018

Study information

• Verified date: September 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 15, 2018
• Est. primary completion date: September 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

Drug:
• 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.
• 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

Locations

Country	Name	City	State
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	The First People's Hospital of Xuzhou	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (6)

Busbee BG, Ho AC, Brown DM, Heier JS, Suñer IJ, Li Z, Rubio RG, Lai P; HARBOR Study Group. Twelve-month efficacy and safety of 0.5 mg or 2.0 mg ranibizumab in patients with subfoveal neovascular age-related macular degeneration. Ophthalmology. 2013 May;12 — View Citation

Koh A, Lee WK, Chen LJ, Chen SJ, Hashad Y, Kim H, Lai TY, Pilz S, Ruamviboonsuk P, Tokaji E, Weisberger A, Lim TH. EVEREST study: efficacy and safety of verteporfin photodynamic therapy in combination with ranibizumab or alone versus ranibizumab monothera — View Citation

Kokame GT, Yeung L, Lai JC. Continuous anti-VEGF treatment with ranibizumab for polypoidal choroidal vasculopathy: 6-month results. Br J Ophthalmol. 2010 Mar;94(3):297-301. doi: 10.1136/bjo.2008.150029. Epub 2009 Sep 1. — View Citation

Kokame GT. Prospective evaluation of subretinal vessel location in polypoidal choroidal vasculopathy (PCV) and response of hemorrhagic and exudative PCV to high-dose antiangiogenic therapy (an American Ophthalmological Society thesis). Trans Am Ophthalmol — View Citation

Obata R, Yanagi Y, Kami J, Takahashi H, Inoue Y, Tamaki Y. Polypoidal choroidal vasculopathy and retinochoroidal anastomosis in Japanese patients eligible for photodynamic therapy for exudative age-related macular degeneration. Jpn J Ophthalmol. 2006 Jul- — View Citation

Sho K, Takahashi K, Yamada H, Wada M, Nagai Y, Otsuji T, Nishikawa M, Mitsuma Y, Yamazaki Y, Matsumura M, Uyama M. Polypoidal choroidal vasculopathy: incidence, demographic features, and clinical characteristics. Arch Ophthalmol. 2003 Oct;121(10):1392-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who have at least 1 polyp resolution	Number of participants who have at least 1 polyp resolution, assessed by Indocyanine angiography (ICGA) between baseline and Month 6	6 months
Secondary	change of best corrected visual acuity(BCVA)	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	Baseline to 6 months
Secondary	change of central foveal thickness	Mean change of central foveal thickness, from baseline to the end of 6 month. As assessed by optical coherence tomography scanning	Baseline to 6 months
Secondary	Injection frequency	Average injection number(from baseline to the end of 6 month), assessed by the number of intravitreal injection from baseline to month 6	Baseline to 6 months
Secondary	Safety analysis: number of adverse event	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.	6 months