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

Retinal Detachment Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01261533
• Other study ID #: VISBOR-61165995002
• Status: Recruiting
• Phase: Phase 1
• First received: December 15, 2010
• Last updated: May 22, 2013
• Start date: September 2010
• Est. completion date: June 2014

Study information

• Verified date: May 2013
• Source: GuangZhou WeiShiBo Biotechnology Co., ltd
• Contact: Lian Zhou
• Phone: 020-61165995
• Email: vesber_zl[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Retinal Detachment

Intervention

Device:
• foldable capsular vitreous body(FCVB)
FCVB with silicone oil inside is tamponaded into the vitreous cavity

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing
China	Southwest Hospital	Chongqing	Chongqing
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	GuangZhou	Guangdong
China	The 2nd affiliated hospital of Harbin Medicinal University.	Harbin	Heilongjiang
China	Peking Union Medical College Hospital	Peking	Beijing
China	Eye and ENT Hospital of FuDan University	Shanghai	Shanghai
China	The affiliated Eye Hospital of Wenzhou Medical College	Wenzhou	Zhejiang
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	XiJing Hospital	Xian	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
GuangZhou WeiShiBo Biotechnology Co., ltd	Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View 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. Epub 2007 May 25. — View 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. — View 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. — View 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. — View 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. — View 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 Experiment Ophthalmol. 2012 Jan-Feb;40(1):e67-75. doi: 10.1111/j.1442-9071.2011.02664.x. Epub 2011 Oct 20. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete retinal reattach rate at the 52 weeks after implantation of the FCVB		52 weeks after implantation of the FCVB	Yes
Secondary	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.	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)	Yes