Flexibility, Efficacy, and Safety of a Foldable Capsular Vitreous Body in the Treatment of Severe Retinal Detachment

NCT01261533 | Unknown Phase 1 DMC

• 1 other identifier: VISBOR-61165995002
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to determine the feasibility, primary safety and efficacy of foldable capsular vitreous body (FCVB) in the treatment of retinal detachment, based on the multi-center clinical trial.

Conditions

Retinal Detachment

Keywords

vitreous body substitute; foldable capsular vitreous body

Outcome Measures

Primary Outcomes (1)

• Complete retinal reattach rate at the 52 weeks after implantation of the FCVB

  52 weeks after implantation of the FCVB

Secondary Outcomes (1)

• Retinal reattach rate, Visual function，and Silicone oil change

  Before surgery, 3days,1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks after FCVB implantation surgery (If patients ask for the delay of removal of FCVB, the patients must received a review every three months)

Study Arms (1)

FCVB team

EXPERIMENTAL

the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB)

Device: foldable capsular vitreous body(FCVB)

Interventions

foldable capsular vitreous body(FCVB) DEVICE

FCVB with silicone oil inside is tamponaded into the vitreous cavity

Also known as: FCVB

FCVB team

Eligibility Criteria

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

You may qualify if:

• age range from 18 to 65, Refractive error less than ±3D
• Corrected visual acuity less than 0.05
• ocular axial length is 16 to 25mm
• severe retinal detachment that can not be treated by current artificial vitreous body:
• Severe unilateral ocular perforating injuries, compounded retinal or choroidal detachments resulted from retinal rupture or retinal choroidal hemorrhage.
• Severe unilateral ocular rupture injuries result in retina or choroid defect.
• Giant posterior scleral rupture injuries that can not be repaired.
• Silicone oil can't be taken out for a long time with incomplete reattachment.
• Participants have undergone retinal detachment surgery and silicone oil tamponade twice or more, however, retina is re-detachment after silicone oil removal.
• Participants can understand the aim of this clinical trial and sign the informed consent form

You may not qualify if:

• Participants have a silica gel allergy or scar diathesis
• entophthalmia
• uveitis
• The contralateral eye suffered from intraocular surgery
• uncontrollable the other eye diseases
• Corrected visual acuity of contralateral eye less than 0.4
• Proliferative diabetic retinopathy
• the lens of target eye is transparent
• Serious heart, lung, liver and kidney dysfunction
• pregnancy, preparation for pregnancy during clinical trial and breast-feeding female
• drug abuse or alcoholism
• participated the other drug or medical devices clinical trial before screening of this trial
• Any research doctors consider that the condition of participants will hinder the clinical trial--Prone to mental stress, loss control of mood, depression etc.
• Patient adherence is so poor that study procedures can not be finished

Sponsors & Collaborators

• GuangZhou WeiShiBo Biotechnology Co., ltd: lead
• Sun Yat-sen University: collaborator

Study Sites (9)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

The 2nd affiliated hospital of Harbin Medicinal University.

Harbin, Heilongjiang, 150001, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Eye and ENT Hospital of FuDan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

XiJing Hospital

Xian, Shanxi, 710032, China

RECRUITING

The affiliated Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

RECRUITING

Related Publications (8)

• Gao Q, Mou S, Ge J, To CH, Hui Y, Liu A, Wang Z, Long C, Tan J. A new strategy to replace the natural vitreous by a novel capsular artificial vitreous body with pressure-control valve. Eye (Lond). 2008 Mar;22(3):461-8. doi: 10.1038/sj.eye.6702875. Epub 2007 May 25.

  PMID: 17525767 BACKGROUND

• Gao Q, Chen X, Ge J, Liu Y, Jiang Z, Lin Z, Liu Y. Refractive shifts in four selected artificial vitreous substitutes based on Gullstrand-Emsley and Liou-Brennan schematic eyes. Invest Ophthalmol Vis Sci. 2009 Jul;50(7):3529-34. doi: 10.1167/iovs.08-2802. Epub 2009 Mar 5.

  PMID: 19264881 BACKGROUND

• Liu Y, Jiang Z, Gao Q, Ge J, Chen J, Cao X, Shen Q, Ma P. Technical standards of a foldable capsular vitreous body in terms of mechanical, optical, and biocompatible properties. Artif Organs. 2010 Oct;34(10):836-45. doi: 10.1111/j.1525-1594.2010.01006.x.

  PMID: 20618225 BACKGROUND

• Liu Y, Ke Q, Chen J, Wang Z, Xie Z, Jiang Z, Ge J, Gao Q. Sustained mechanical release of dexamethasone sodium phosphate from a foldable capsular vitreous body. Invest Ophthalmol Vis Sci. 2010 Mar;51(3):1636-42. doi: 10.1167/iovs.09-4134. Epub 2009 Oct 15.

  PMID: 19834025 BACKGROUND

• Lin X, Ge J, Gao Q, Wang Z, Long C, He L, Liu Y, Jiang Z. Evaluation of the flexibility, efficacy, and safety of a foldable capsular vitreous body in the treatment of severe retinal detachment. Invest Ophthalmol Vis Sci. 2011 Jan 21;52(1):374-81. doi: 10.1167/iovs.10-5869.

  PMID: 20811065 BACKGROUND

• Zhang R, Wang T, Xie C, Lin X, Jiang Z, Wang Z, Liu Y, Luo Y, Long C, He L, Wang P, Gao Q. Evaluation of supporting role of a foldable capsular vitreous body with magnetic resonance imaging in the treatment of severe retinal detachment in human eyes. Eye (Lond). 2011 Jun;25(6):794-802. doi: 10.1038/eye.2011.61. Epub 2011 Mar 18.

  PMID: 21423138 BACKGROUND

• Wang P, Gao Q, Jiang Z, Lin J, Liu Y, Chen J, Zhou L, Li H, Yang Q, Wang T. Biocompatibility and retinal support of a foldable capsular vitreous body injected with saline or silicone oil implanted in rabbit eyes. Clin Exp Ophthalmol. 2012 Jan-Feb;40(1):e67-75. doi: 10.1111/j.1442-9071.2011.02664.x. Epub 2011 Oct 20.

  PMID: 21883770 BACKGROUND

• Lin X, Wang Z, Jiang Z, Long C, Liu Y, Wang P, Jin C, Yi C, Gao Q. Preliminary efficacy and safety of a silicone oil-filled foldable capsular vitreous body in the treatment of severe retinal detachment. Retina. 2012 Apr;32(4):729-41. doi: 10.1097/IAE.0b013e31822b1f80.

  PMID: 22105508 BACKGROUND

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Qianying Gao, MD,Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lian Zhou

CONTACT

020-61165995; vesber_zl@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 16, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: May 23, 2013

Record last verified: 2013-05

Locations

CN (9)