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Retinal DetachmentPhase 1NCT01261533

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

A Phase 1 study testing foldable capsular vitreous body(FCVB) in people with Retinal Detachment, run by GuangZhou WeiShiBo Biotechnology Co., ltd at 9 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Retinal Detachment
What is being tested?
foldable capsular vitreous body(FCVB)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
9 sitesChina
Study dates
Sep 2010to Jun 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

Lian Zhou contact

020-61165995

vesber_zl@163.com

9 sites in 1 country

China9 sites, 9 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

    010-65296114

    Recruiting

  • Beijing Tongren Hospital

    Beijing, Beijing Municipality, 100730

    010-11616669

    Recruiting

  • Southwest Hospital

    Chongqing, Chongqing Municipality, 400038

    023-65318301

    Recruiting

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510000

    Xia Huang, 020-87330490, gaoketizu@163.com

    Recruiting

  • The 2nd affiliated hospital of Harbin Medicinal University.

    Harbin, Heilongjiang, 150001

    0451-86662961

    Recruiting

  • Eye and ENT Hospital of FuDan University

    Shanghai, Shanghai Municipality, 200031

    021-64377134

    Recruiting

  • The affiliated Eye Hospital of Wenzhou Medical College

    Wenzhou, Zhejiang, 325027

    0577-88068822

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

    027-88041911

    Recruiting

  • XiJing Hospital

    Xian, Shanxi, 710032

    029-3375015

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
foldable capsular vitreous body(FCVB)
Keywords
vitreous body substitute, foldable capsular vitreous body
Medical subject headings
Retinal Detachment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • foldable capsular vitreous body(FCVB)Device

    Also called FCVB

    FCVB with silicone oil inside is tamponaded into the vitreous cavity

Study groups in NCT01261533
Study groupRoleWhat they receive
FCVB teamExperimentalthe vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB)
Receives: Device: foldable capsular vitreous body(FCVB)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 52 weeks after implantation of the FCVB

Secondary outcomes (1)

  1. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionDec 2013 (estimated)
  4. Study completionJun 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01261533
Sponsor's protocol ID
VISBOR-61165995002
Status last verified
May 2013
First submitted
15 Dec 2010
Last updated
23 May 2013
Results posted
No
Data monitoring committee
Yes

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 (Lond). 2008 Mar;22(3):461-8. doi: 10.1038/sj.eye.6702875. Epub 2007 May 25.

    PubMed 17525767

  • 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.

    PubMed 19264881

  • 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.

    PubMed 20618225

  • 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.

    PubMed 19834025

  • 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.

    PubMed 20811065

  • 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.

    PubMed 21423138

  • 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.

    PubMed 21883770

  • 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.

    PubMed 22105508

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing foldable capsular vitreous body(FCVB) in people with Retinal Detachment, run by GuangZhou WeiShiBo Biotechnology Co., ltd at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lian Zhou (020-61165995, vesber_zl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete retinal reattach rate at the 52 weeks after implantation of the FCVB (time frame: 52 weeks after implantation of the FCVB). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01261533, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2013.

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