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

Purpose

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.

Condition	Intervention	Phase
Retinal Detachment	Device: foldable capsular vitreous body(FCVB)	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Further study details as provided by GuangZhou WeiShiBo Biotechnology Co., ltd:

Primary Outcome Measures:

Complete retinal reattach rate at the 52 weeks after implantation of the FCVB [ Time Frame: 52 weeks after implantation of the FCVB ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Retinal reattach rate, Visual function，and Silicone oil change [ 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) ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	122
Study Start Date:	September 2010
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: FCVB team the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB)	Device: foldable capsular vitreous body(FCVB) FCVB with silicone oil inside is tamponaded into the vitreous cavity Other Name: FCVB

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:
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.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261533

Contacts

Contact: Lian Zhou

020-61165995

vesber_zl@163.com

Locations

China, Beijing
Beijing Tongren Hospital	Recruiting
Beijing, Beijing, China, 100730
Contact 010-11616669
Peking Union Medical College Hospital	Recruiting
Peking, Beijing, China, 100032
Contact 010-65296114
China, Chongqing
Southwest Hospital	Recruiting
Chongqing, Chongqing, China, 400038
Contact 023-65318301
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University	Recruiting
GuangZhou, Guangdong, China, 510000
Contact: Xia Huang 020-87330490 gaoketizu@163.com
China, Heilongjiang
The 2nd affiliated hospital of Harbin Medicinal University.	Recruiting
Harbin, Heilongjiang, China, 150001
Contact 0451-86662961
China, Hubei
Renmin Hospital of Wuhan University	Recruiting
Wuhan, Hubei, China, 430060
Contact 027-88041911
China, Shanghai
Eye and ENT Hospital of FuDan University	Recruiting
Shanghai, Shanghai, China, 200031
Contact 021-64377134
China, Shanxi
XiJing Hospital	Recruiting
Xian, Shanxi, China, 710032
Contact 029-3375015
China, Zhejiang
The affiliated Eye Hospital of Wenzhou Medical College	Recruiting
Wenzhou, Zhejiang, China, 325027
Contact 0577-88068822

Sponsors and Collaborators

GuangZhou WeiShiBo Biotechnology Co., ltd

Sun Yat-sen University

Investigators

Principal Investigator:

Qianying Gao, MD,Ph.D

Zhongshan Ophthalmic Center, Sun Yat-sen University

More Information

Publications:

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. 2008 Mar;22(3):461-8. Epub 2007 May 25.

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 Mar 5; [Epub ahead of print]

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.

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. Epub 2009 Oct 15.

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. Print 2011.

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.

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 Experiment Ophthalmol. 2012 Jan-Feb;40(1):e67-75. doi: 10.1111/j.1442-9071.2011.02664.x. Epub 2011 Oct 20.

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.

Responsible Party:	GuangZhou WeiShiBo Biotechnology Co., ltd
ClinicalTrials.gov Identifier:	NCT01261533 History of Changes
Other Study ID Numbers:	VISBOR-61165995002
Study First Received:	December 15, 2010
Last Updated:	May 22, 2013
Health Authority:	China: Food and Drug Administration

Keywords provided by GuangZhou WeiShiBo Biotechnology Co., ltd:

vitreous body substitute
foldable capsular vitreous body

Additional relevant MeSH terms:

Retinal Detachment
Dissociative Disorders
Retinal Diseases
Eye Diseases
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013