Retinal DetachmentEarly Phase 1NCT00910702
The Exploratory Clinical Trials for the Feasibility, Primary Safety and Efficacy of Foldable Capsular Vitreous Body
A Early Phase 1 study testing foldable capsular vitreous body(FCVB) in people with Retinal Detachment, run by GuangZhou WeiShiBo Biotechnology Co., ltd at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 10 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
- 15 participants
- Where
- 1 siteChina
- Study dates
- May 2009to Mar 2013
- Phase
- Early 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 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Refractive error less than ±3D
- Visual acuity worse than finger count
- Ocular perforating injuries, traumatic retinal detachment, giant retinal tear with PVR, serious than grade D PVR, ocular axial length is 16 to 25mm
- Signed the informed consent form
Who cannot join
- Serious heart, lung, liver and kidney dysfunction
- Serious eye inflammation
- Silicone oil filled eyes
- The contralateral eye is non-functional
- Patients with diseases that the researchers consider not suitable participated in this clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
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.
Read the detailed description
Pars plana vitrectomy (PPV) has been one of the most important ophthalmic surgeries for treating a number of blinding diseases by removing and replacing the diseased vitreous body. Current clinic vitreous substitute cannot mimic the natural vitreous which is unable to regenerate after surgery. We have devised a novel foldable capsular vitreous body (FCVB) consisting of a vitreous-like capsule with a tube-valve system, and demonstrated it could finely mimic the morphology and restore main physiological function of the natural vitreous body in our previous study.
- Conditions
- Retinal Detachment
- Being tested
- foldable capsular vitreous body(FCVB)
- Keywords
- retinal detachment, vitreous body substitute
- 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
the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB) after PPV
| Study group | Role | What they receive |
|---|---|---|
| FCVB team | Experimental | the 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.
Complete retinal reattach rate at the three years after implantation of the silicone-filled FCVB
FCVBs filled with balanced salt solution (BSS) were removed from all 11 cases, however, the risk of retinal redetachment and blindness rises after earlier FCVB removal. Approved by the Sun Yat-sen University Medical Ethics Committee, the removal of the FCVB will be decided by doctors depending on the conditions of eye. The eyes implanted with the silicone oil-filled FCVB are still under observation.
Measured: three years after implantation of the FCVB
Secondary outcomes (1)
visual acuity, intraocular pressure, axial length, ocular inflammatory response, the number of corneal endothelial, anterior chamber angle and ciliary body change, morphological changes of the ocular and FCVB.
FCVBs filled with BSS were removed from all 11 cases, however, the risk of retinal redetachment and blindness rises after earlier FCVB removal. Approved by the Sun Yat-sen University Medical Ethics Committee, the removal of the FCVB will be decided by doctors depending on the conditions of eye. The eyes implanted with the FCVB and silicone oil are still under observation.
Measured: Before surgery, 3days,1 week, 2 weeks, 4 weeks, 8 weeks, 3 months, 6 months, 9 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after surgery, and 3 months after the removal of the FCVB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- GuangZhou WeiShiBo Biotechnology Co., ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor
- Investigators
- Qianying Gao, MD,Ph.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910702
- Sponsor's protocol ID
- VISBOR-61165995
- Status last verified
- Apr 2013
- First submitted
- 28 May 2009
- Last updated
- 30 Apr 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 17525767Gao 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 19264881Lin 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exploratory Clinical Trials for the Feasibility, Primary Safety and Efficacy of Foldable Capsular Vitreous Body
- ClinicalTrials.gov ID
- NCT00910702
- Acronym / sponsor ID
- VISBOR-61165995
- Conditions
- Retinal Detachment
- Keywords
- retinal detachment, vitreous body substitute
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GuangZhou WeiShiBo Biotechnology Co., ltdIndustry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Study start
- May 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 1 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pars plana vitrectomy (PPV) has been one of the most important ophthalmic surgeries for treating a number of blinding diseases by removing and replacing the diseased vitreous body. Current clinic vitreous substitute cannot mimic the natural vitreous which is unable to regenerate after surgery. We have devised a novel foldable capsular vitreous body (FCVB) consisting of a vitreous-like capsule with a tube-valve system, and demonstrated it could finely mimic the morphology and restore main physiological function of the natural vitreous body in our previous study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FCVB team | Experimental | Device: foldable capsular vitreous body(FCVB)the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB) |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Refractive error less than ±3D
- Visual acuity worse than finger count
- Ocular perforating injuries, traumatic retinal detachment, giant retinal tear with PVR, serious than grade D PVR, ocular axial length is 16 to 25mm
- Signed the informed consent form
Key exclusion criteria (5 listed)
- Serious heart, lung, liver and kidney dysfunction
- Serious eye inflammation
- Silicone oil filled eyes
- The contralateral eye is non-functional
- Patients with diseases that the researchers consider not suitable participated in this clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| foldable capsular vitreous body(FCVB)Also: FCVBthe vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB) after PPV | Device | FCVB team |
Primary outcome
Complete retinal reattach rate at the three years after implantation of the silicone-filled FCVB
Time frame: three years after implantation of the FCVB
FCVBs filled with balanced salt solution (BSS) were removed from all 11 cases, however, the risk of retinal redetachment and blindness rises after earlier FCVB removal. Approved by the Sun Yat-sen University Medical Ethics Committee, the removal of the FCVB will be decided by doctors depending on the conditions of eye. The eyes implanted with the silicone oil-filled FCVB are still under observation.
1 secondary outcome
visual acuity, intraocular pressure, axial length, ocular inflammatory response, the number of corneal endothelial, 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, 3 months, 6 months, 9 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after surgery, and 3 months after the removal of the FCVB
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
- Results publication: PubMed 17525767Gao 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 publication: PubMed 19264881Gao 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.
- Derived from this study: PubMed 20811065Lin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qianying Gao, MD,Ph.D principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing foldable capsular vitreous body(FCVB) in people with Retinal Detachment, run by GuangZhou WeiShiBo Biotechnology Co., ltd at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete retinal reattach rate at the three years after implantation of the silicone-filled FCVB (time frame: three years 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 NCT00910702, which also lists 3 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 30 Apr 2013.