Neovascular GlaucomaNCT03154892
The Effect of Conbercept Injection Through Different Routes for Neovascular Glaucoma
A study testing Intracameral injection and Intravitreal injection in people with Neovascular Glaucoma, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
The neovascular glaucoma (NVG) is a refractory type of secondary glaucoma and often lead to frustrated treatment and blindness. It has been confirmed high levels of vascular endothelial growth factor (VEGF) in NVG. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Neovascular Glaucoma
- What is being tested?
- Intracameral injection and Intravitreal injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 31 Dec 2017
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of neovascular glaucoma (Stage 1-2-3)
- Individuals who are ages 20-80 years old; male or female of chinese
- Visual acuity of light perception or better in the study eye
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Who cannot join
- Use of intraocular anti-VEGF agents in the study eye in the past 3 months.
- Active ocular or periocular infection in the study eye
- Uncontrolled Blood Pressure
- Thromboembolism
- Congestive Heart Failure
- Renal Failure
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- History of myocardial infarction
- History of Stroke
- Pregnant or breast-feeding women
- Participation in another simultaneous medical investigator or trial
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710004
About this study
The neovascular glaucoma (NVG) is a refractory type of secondary glaucoma and often lead to frustrated treatment and blindness. It has been confirmed high levels of vascular endothelial growth factor (VEGF) in NVG. Conbercept is an anti-VEGF agent，its role in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic retinopathy has been described. Investigators aim to evaluate the efficacy and safety of intracameral and intravitreal injection of conbercept for the treatment of NVG.
Read the detailed description
The neovascular glaucoma (NVG) is a refractory type of secondary glaucoma and often lead to frustrated treatment and blindness. It has been confirmed high levels of vascular endothelial growth factor (VEGF) in NVG. Conbercept is an anti-VEGF agent，Its role in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic retinopathy has been described. The intravitreal injection of anti-VEGF agent has shown its therapeutic potential for the early stage of NVG, but not for the late stage. Intracameral injection maybe used as an alternative way for administration. Investigators aim to evaluate the efficacy and safety of intracameral and intravitreal injection of conbercept for the treatment of NVG.
- Conditions
- Neovascular Glaucoma
- Being tested
- Intracameral injection, Intravitreal injection
- Medical subject headings
- Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracameral injectionProcedure or surgery
Intracameral Conbercept injection for the treatment of NVG
Intravitreal injectionProcedure or surgery
Intravitreal Conbercept injection for the treatment of NVG
| Study group | Role | What they receive |
|---|---|---|
| Intracameral injection | Experimental | Intracameral injection of conbercept for the treatment of NVG Receives: Procedure: Intracameral injection |
| Intravitreal injection | Active comparator | Intravitreal injection of conbercept for the treatment of NVG Receives: Procedure: Intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
NVI/NVA
Changes in extent of iris or angle neovascularization
Measured: 1 week and 1 month after operation
Secondary outcomes (2)
IOP
Changes in Intraocular pressure
Measured: 1 week and 1 month after operation
BCVA
Changes in best corrected visual acuity
Measured: 1 week and 1 month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Apr 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular GlaucomaStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ling Bai, MD,PhD, Principal investigator, Second affiliated hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154892
- Sponsor's protocol ID
- Conbercept Injection
- Status last verified
- May 2018
- First submitted
- 7 May 2017
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Publications
Bai L, Wang Y, Liu X, Zheng Y, Wang W, He N, Tariq F, Wang F, Zhang S. The Optimization of an Anti-VEGF Therapeutic Regimen for Neovascular Glaucoma. Front Med (Lausanne). 2022 Jan 10;8:766032. doi: 10.3389/fmed.2021.766032. eCollection 2021.
PubMed 35083234
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Conbercept Injection Through Different Routes for Neovascular Glaucoma
- ClinicalTrials.gov ID
- NCT03154892
- Acronym / sponsor ID
- Conbercept Injection
- Conditions
- Neovascular Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 16 May 2017 (actual)
- 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 neovascular glaucoma (NVG) is a refractory type of secondary glaucoma and often lead to frustrated treatment and blindness. It has been confirmed high levels of vascular endothelial growth factor (VEGF) in NVG. Conbercept is an anti-VEGF agent，its role in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic retinopathy has been described. Investigators aim to evaluate the efficacy and safety of intracameral and intravitreal injection of conbercept for the treatment of NVG.
Detailed description
The neovascular glaucoma (NVG) is a refractory type of secondary glaucoma and often lead to frustrated treatment and blindness. It has been confirmed high levels of vascular endothelial growth factor (VEGF) in NVG. Conbercept is an anti-VEGF agent，Its role in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic retinopathy has been described. The intravitreal injection of anti-VEGF agent has shown its therapeutic potential for the early stage of NVG, but not for the late stage. Intracameral injection maybe used as an alternative way for administration. Investigators aim to evaluate the efficacy and safety of intracameral and intravitreal injection of conbercept for the treatment of NVG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracameral injection | Experimental | Procedure: Intracameral injectionIntracameral injection of conbercept for the treatment of NVG |
| Intravitreal injection | Active comparator | Procedure: Intravitreal injectionIntravitreal injection of conbercept for the treatment of NVG |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a diagnosis of neovascular glaucoma (Stage 1-2-3)
- Individuals who are ages 20-80 years old; male or female of chinese
- Visual acuity of light perception or better in the study eye
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Key exclusion criteria (10 listed)
- Use of intraocular anti-VEGF agents in the study eye in the past 3 months.
- Active ocular or periocular infection in the study eye
- Uncontrolled Blood Pressure
- Thromboembolism
- Congestive Heart Failure
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 |
|---|---|---|
| Intracameral injectionIntracameral Conbercept injection for the treatment of NVG | Procedure or surgery | Intracameral injection |
| Intravitreal injectionIntravitreal Conbercept injection for the treatment of NVG | Procedure or surgery | Intravitreal injection |
Primary outcome
NVI/NVA
Time frame: 1 week and 1 month after operation
Changes in extent of iris or angle neovascularization
2 secondary outcomes
IOP
Time frame: 1 week and 1 month after operation
BCVA
Time frame: 1 week and 1 month after operation
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 23 May 2018.
- Derived from this study: PubMed 35083234Bai L, Wang Y, Liu X, Zheng Y, Wang W, He N, Tariq F, Wang F, Zhang S. The Optimization of an Anti-VEGF Therapeutic Regimen for Neovascular Glaucoma. Front Med (Lausanne). 2022 Jan 10;8:766032. doi: 10.3389/fmed.2021.766032. eCollection 2021.
- Individual participant dataSharing planned: No. No plan to share IPD
Related trials for Neovascular Glaucoma
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Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT
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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.
Ling Bai, MD,PhD principal investigator
Second affiliated hospital of Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracameral injection and Intravitreal injection in people with Neovascular Glaucoma, run by Second Affiliated Hospital of Xi'an Jiaotong University 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 5 inclusion and 10 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 23 May 2018. 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.
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?
NVI/NVA (time frame: 1 week and 1 month after operation). 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 NCT03154892, which also lists 1 linked publication.
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 2018.