Safety and Efficacy of Two Regimens of Ranibizumab 0.5 mg in Chinese Patients With Neovascular AMD

NCT02810808 | Unknown Phase 4 DMC

• 1 other identifier: 13411950400
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 5

Brief Summary

The study will evaluate the efficacy and safety of two different dosing regimens of ranibizumab (0.5 mg on BCVA by 1+PRN vs 3+PRN) in Chinese patients with wet AMD. This study is to provide long-term safety data in the treatment of Chinese patients with wet AMD.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

Neovascular Age-related Macular Degeneration; Ranibizumab; Pro Re Nata

Outcome Measures

Primary Outcomes (1)

• Mean Snellen BCVA at every visit

  Compare of mean Snellen Best-Corrected-visual-acuity and mean central macular thickness by OCT at every visit or treatment between the two groups to assess the efficacy of 1+PRN of Ranibizumab.

  12 months

Secondary Outcomes (3)

• Number of participants with treatment-related adverse events

  12 months

• Mean number of injections in 12 months

  12 months

• mean central macular thickness at every visit by OCT

  12 months

Study Arms (2)

Ranibizumab 0.5 mg 1+PRN

EXPERIMENTAL

PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 11 month treatment period Intervention: Drug: Ranibizumab

Procedure: 1+PRN; Drug: Ranibizumab

Ranibizumab 0.5 mg 3+PRN

ACTIVE COMPARATOR

PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization after three Monthly intravitreal injections of the same dose.

Procedure: 3+PRN; Drug: Ranibizumab

Interventions

1+PRN PROCEDURE

PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the injection of the same does at the first month.

Ranibizumab 0.5 mg 1+PRN

3+PRN PROCEDURE

PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the first three monthly intravitreal injections of the same does.

Ranibizumab 0.5 mg 3+PRN

Ranibizumab DRUG

Ranibizumab - a recombinant, humanized monoclonal antibody Fab that neutralizes all active forms of VEGF-A was recently approved by the Food and Drug Administration for the treatment of all angiographic subtypes of subfoveal neovascular age-related macular degeneration

Also known as: Lucentis

Ranibizumab 0.5 mg 1+PRN; Ranibizumab 0.5 mg 3+PRN

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed-consent before any evaluation
• Visual impairment due to active CNV,including predominantly classic CNV,minimally classic CNV,occult CNV with no classic component and PCV.
• years old and older
• Chinese
• For study eye: screening and baseline BCVA scores both should be between 78 and 23 words (including 78 and 23 words) (approximately equals to 20/30-20/320 sneeleen vision chart units) while tested at 4 meters with ETDRS vision chart.

You may not qualify if:

• Have Stroke and myocardial infarction within 3 months before screening
• Any active periocular and ocular infection and inflammation (including blepharitis, conjunctivitis, keratitis, scleritis, uveitis, intraocular inflammation) while screening and baseline.
• Uncontrolled glaucoma (under treatment \[IOP\] ≥ 30 mm Hg or depend on researchers) while screening and baseline
• Neovascularization of iris and neovascular glaucoma while screening and baseline
• Any causes led to choroidal neovascularization except Wet AMD (including ICNV,central serous chorioretinopathy,ocular histoplazmoza and pathologic myopia) while screening and baseline
• With structure injury (including vitreous macular traction,epiretinal membrane involving in central fovea,subretinal fibroplasia,laser scar and central fovea atrophy) within 0.5 optic disc diameter to the central of macula while screening and baseline, which may harm the improvement of vision by treatment according to researchers
• Any systemic anti-VEGF medication(as Avastin) use within 3 months before screening
• Any medication systemic use toxic to lens, retina and optic nerve,including iron amine, chloroquine/chloroquine (Plaquenil ®), tamoxifen, phenothiazine and ethambutol
• For study eye：Used to accept following treatments for wet AMD within 3 months or accept following treatments more than three times before baseline: a)Anti-angiogenesis drugs(pegaptanib （Macugen®），ranibizumab ,bevacizumab（Avastin®),VEGF-Trap，KH902；b）Anecortave acetate corticosteroids；c）Protein kinase C inhibitors，squalamine，siRNA; d)PDT （Visudyne®）treatment,external beam radiotherapy, local laser photocoagulation, vitrectomy, submacular surgery and transpupillary thermotherapy
• Any intraocular surgery(including YAG laser) within 3 months before baseline or predicated within 6 months after baseline
• Intraocular or periocular treatment of corticosteroids within 3 months before baseline
• For follow eye:Any anti-angiogenesis treatment(including anti-VEGF,like Lucentis,Avastin® and KH902 ) within 3 months before baseline

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Eye & ENT Hospital of Fudan University: collaborator
• Shanghai 10th People's Hospital: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai Zhongshan Hospital: collaborator

Study Sites (5)

Eye & Ent Hospital of Fudan University

Shanghai, 200080, China

RECRUITING

Shanghai 10th People's Hospital

Shanghai, 200080, China

RECRUITING

Shanghai First People's Hospital

Shanghai, 200080, China

RECRUITING

Shanghai Zhongshan Hospital

Shanghai, 200080, China

RECRUITING

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200080, China

RECRUITING

Related Publications (10)

• Friedman DS, Katz J, Bressler NM, Rahmani B, Tielsch JM. Racial differences in the prevalence of age-related macular degeneration: the Baltimore Eye Survey. Ophthalmology. 1999 Jun;106(6):1049-55. doi: 10.1016/S0161-6420(99)90267-1.

  PMID: 10366070 BACKGROUND

• Smith W, Assink J, Klein R, Mitchell P, Klaver CC, Klein BE, Hofman A, Jensen S, Wang JJ, de Jong PT. Risk factors for age-related macular degeneration: Pooled findings from three continents. Ophthalmology. 2001 Apr;108(4):697-704. doi: 10.1016/s0161-6420(00)00580-7.

  PMID: 11297486 BACKGROUND

• Hsu WM, Cheng CY, Liu JH, Tsai SY, Chou P. Prevalence and causes of visual impairment in an elderly Chinese population in Taiwan: the Shihpai Eye Study. Ophthalmology. 2004 Jan;111(1):62-9. doi: 10.1016/j.ophtha.2003.05.011.

  PMID: 14711715 BACKGROUND

• Miyazaki M, Nakamura H, Kubo M, Kiyohara Y, Oshima Y, Ishibashi T, Nose Y. Risk factors for age related maculopathy in a Japanese population: the Hisayama study. Br J Ophthalmol. 2003 Apr;87(4):469-72. doi: 10.1136/bjo.87.4.469.

  PMID: 12642312 BACKGROUND

• Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.

  PMID: 17021318 BACKGROUND

• Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655.

  PMID: 17021319 BACKGROUND

• Lalwani GA, Rosenfeld PJ, Fung AE, Dubovy SR, Michels S, Feuer W, Davis JL, Flynn HW Jr, Esquiabro M. A variable-dosing regimen with intravitreal ranibizumab for neovascular age-related macular degeneration: year 2 of the PrONTO Study. Am J Ophthalmol. 2009 Jul;148(1):43-58.e1. doi: 10.1016/j.ajo.2009.01.024. Epub 2009 Apr 18.

  PMID: 19376495 BACKGROUND

• Tano Y, Ohji M; EXTEND-I Study Group. EXTEND-I: safety and efficacy of ranibizumab in Japanese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. Acta Ophthalmol. 2010 May;88(3):309-16. doi: 10.1111/j.1755-3768.2009.01843.x. Epub 2010 Feb 16.

  PMID: 20163368 BACKGROUND

• CATT Research Group; Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011 May 19;364(20):1897-908. doi: 10.1056/NEJMoa1102673. Epub 2011 Apr 28.

  PMID: 21526923 BACKGROUND

• Wang F, Yuan Y, Wang L, Ye X, Zhao J, Shen M, Zhang Q, Xu D, Qin G, Zhang W, Yuan F, Chang Q, Zhao P, Wang F, Sun X. One-Year Outcomes of 1 Dose versus 3 Loading Doses Followed by Pro Re Nata Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration: The ARTIS Trial. J Ophthalmol. 2019 Oct 10;2019:7530458. doi: 10.1155/2019/7530458. eCollection 2019.

  PMID: 31687203 DERIVED

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xiaodong Sun, M.D.

  Shanghai General Hospital, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaodong Sun, M.D.

CONTACT

+86-02163240090; xdsun@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Executive Vicechair of Department of Ophthalmology

Study Record Dates

• First Submitted: May 3, 2014
• First Posted: June 23, 2016
• Study Start: December 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: January 1, 2017
• Last Updated: November 4, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)