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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by GuangZhou WeiShiBo Biotechnology Co., ltd
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
GuangZhou WeiShiBo Biotechnology Co., ltd
ClinicalTrials.gov Identifier:
NCT01261533
First received: December 15, 2010
Last updated: May 22, 2013
Last verified: May 2013
  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

Resource links provided by NLM:


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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 01, 2014