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

Primary Purpose

Retinal Detachment

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
foldable capsular vitreous body(FCVB)
Sponsored by
GuangZhou WeiShiBo Biotechnology Co., ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Detachment focused on measuring vitreous body substitute, foldable capsular vitreous body

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age range from 18 to 65, Refractive error less than ±3D
  2. Corrected visual acuity less than 0.05
  3. ocular axial length is 16 to 25mm

  4. severe retinal detachment that can not be treated by current artificial vitreous body:

    1. Severe unilateral ocular perforating injuries, compounded retinal or choroidal detachments resulted from retinal rupture or retinal choroidal hemorrhage.
    2. Severe unilateral ocular rupture injuries result in retina or choroid defect.
    3. Giant posterior scleral rupture injuries that can not be repaired.
    4. Silicone oil can't be taken out for a long time with incomplete reattachment.
    5. Participants have undergone retinal detachment surgery and silicone oil tamponade twice or more, however, retina is re-detachment after silicone oil removal.
  5. Participants can understand the aim of this clinical trial and sign the informed consent form

Exclusion Criteria:

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

Sites / Locations

  • Beijing Tongren HospitalRecruiting
  • Peking Union Medical College HospitalRecruiting
  • Southwest HospitalRecruiting
  • Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
  • The 2nd affiliated hospital of Harbin Medicinal University.Recruiting
  • Renmin Hospital of Wuhan UniversityRecruiting
  • Eye and ENT Hospital of FuDan UniversityRecruiting
  • XiJing HospitalRecruiting
  • The affiliated Eye Hospital of Wenzhou Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FCVB team

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Retinal reattach rate, Visual function，and Silicone oil change
visual acuity, intraocular pressure, axial length, ocular inflammatory response, the number of corneal endothelial, emulsification rate of silicone oil, migration of silicone oil droplets into the anterior, chamber, anterior chamber angle and ciliary body change, morphological changes of the ocular and FCVB.

Full Information

First Posted
December 15, 2010
Last Updated
May 22, 2013
Sponsor
GuangZhou WeiShiBo Biotechnology Co., ltd
Collaborators
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01261533
Brief Title
Flexibility, Efficacy, and Safety of a Foldable Capsular Vitreous Body in the Treatment of Severe Retinal Detachment
Official Title
The Multi-center Exploratory Clinical Trials for the Evaluation of Flexibility, Efficacy, and Safety of a Foldable Capsular Vitreous Body in the Treatment of Severe Retinal Detachment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GuangZhou WeiShiBo Biotechnology Co., ltd
Collaborators
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Previous clinical trial have demonstrated that foldable artificial vitreous body (FCVB),with balanced salt solution (BSS) filled in 11 patients during three-months observation,or silicone oil filled in 4 patients during a six-month observation respectively, can be transplanted into the vitreous body easily, and performances good safety and efficacy in the treatment of severe retinal detachment. Current multi-center clinical trial was to determine the feasibility, primary safety and efficacy of FCVB with silicone oil filled in the treatment of retinal detachment in 120 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
vitreous body substitute, foldable capsular vitreous body

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FCVB team
Arm Type
Experimental
Arm Description
the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB)
Intervention Type
Device
Intervention Name(s)
foldable capsular vitreous body(FCVB)
Other Intervention Name(s)
FCVB
Intervention Description
FCVB with silicone oil inside is tamponaded into the vitreous cavity
Primary Outcome Measure Information:
Title
Complete retinal reattach rate at the 52 weeks after implantation of the FCVB
Time Frame
52 weeks after implantation of the FCVB
Secondary Outcome Measure Information:
Title
Retinal reattach rate, Visual function，and Silicone oil change
Description
visual acuity, intraocular pressure, axial length, ocular inflammatory response, the number of corneal endothelial, emulsification rate of silicone oil, migration of silicone oil droplets into the anterior, chamber, anterior chamber angle and ciliary body change, morphological changes of the ocular and FCVB.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lian Zhou
Phone
020-61165995
Email
vesber_zl@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qianying Gao, MD,Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
010-11616669
Facility Name
Peking Union Medical College Hospital
City
Peking
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
010-65296114
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
023-65318301
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia Huang
Phone
020-87330490
Email
gaoketizu@163.com
Facility Name
The 2nd affiliated hospital of Harbin Medicinal University.
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
0451-86662961
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
027-88041911
Facility Name
Eye and ENT Hospital of FuDan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
021-64377134
Facility Name
XiJing Hospital
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
029-3375015
Facility Name
The affiliated Eye Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
0577-88068822

12. IPD Sharing Statement

Citations:
PubMed Identifier
17525767
Citation
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.
Results Reference
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PubMed Identifier
19264881
Citation
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.
Results Reference
background
PubMed Identifier
20618225
Citation
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.
Results Reference
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PubMed Identifier
19834025
Citation
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.
Results Reference
background
PubMed Identifier
20811065
Citation
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.
Results Reference
background
PubMed Identifier
21423138
Citation
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.
Results Reference
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PubMed Identifier
21883770
Citation
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.
Results Reference
background
PubMed Identifier
22105508
Citation
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.
Results Reference
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Flexibility, Efficacy, and Safety of a Foldable Capsular Vitreous Body in the Treatment of Severe Retinal Detachment

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