UveitisPhase 2/3NCT04296838
Effects of Conbercept in Refractory Uveitic Macular Edema and VEGF
A Phase 2/3 study testing intravitreal injection of Conbercept in people with Uveitis and Macular Edema, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
As a primary exploratory study, this study aims to evaluate the short-term effectiveness of intravitreal Conbercept injection in UME, and to explore the correlation between inflammatory factors like VEGF and the responsiveness to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Macular Edema, Vascular Endothelial Growth Factor
- What is being tested?
- intravitreal injection of Conbercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2019to 12 Feb 2022
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >= 18 years old
- competent in signing the informed consent
- no severe systemic diseases unrelated to uveitis
- fulfill the criteria of refractory UME
Who cannot join
- pregnant or preparing pregnancy
- already in other clinical trials
- blood pressure >= 180/110mmHg
- BCVA of the contralateral eye <= 20/200
- cardiovascular events within 3 months
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital (PUMCH)
Beijing, Beijing Municipality, 100730
About this study
Official title: Effectiveness of Conbercept in Treating Refractory Uveitic Macular Edema and the Changes of VEGF Levels in the Aqueous Humor
As a primary exploratory study, this study aims to evaluate the short-term effectiveness of intravitreal Conbercept injection in UME, and to explore the correlation between inflammatory factors like VEGF and the responsiveness to treatment.
Read the detailed description
Uveitic macular edema (UME) is one of the commonest and severest complications of chronic uveitis, and is also one of the important causes of permanent vision loss in uveitis. The pathophysiological mechanism of UME remains unclear, but was thought to be caused by damages of internal/external blood-retinal barrier mediated by inflammatory factors, including interleukin-2, interleukin-10, tumor necrosis factor α, prostaglandins and vascular endothelial growth factor (VEGF). Current treatments of UME include local or systemic glucocorticosteroids (GCS), immunosuppressants and biological agents. Although large dose of systemic GCS combined with immunosuppressants lead to quick resolution of ME in most of the cases, UME often relapse with tapering of GCS, and the side effects can be significant. Periocular or intraocular injection of GCS is effective in short term, but repetitive injections often lead to high intraocular pressure and cataract. Intravitreal injection of anti-VEGF agents is a huge advance of medical treatment in ophthalmology in recent years. Since 2007 till now, there have been a number of reports on the effectiveness of intraocular Bevacizumab and Ranibizumab injection in UME, but none about Conbercept. Besides, as the target of anti-VEGF agents, intraocular concentration of VEGF and its changes might be correlated to the sensitivity and responsiveness of UME to anti-VEGF agents, but has not been monitored. As a primary exploratory study, this study aims to evaluate the short-term effectiveness of intravitreal Conbercept injection in UME, and to explore the correlation between inflammatory factors like VEGF and the responsiveness to treatment.
- Being tested
- intravitreal injection of Conbercept
- Keywords
- Uveitis, Macular Edema, vascular endothelial growth factor, aqueous humor, Effect of Drugs
- Medical subject headings
- Uveitis, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injection of ConberceptDrug
Also called Lumitin
patients will receive intravitreal injection of Conbercept, and at the same time, aqueous humor sample will be obtained from the anterior chamber to measure the concentrations of cytokines.
| Study group | Role | What they receive |
|---|---|---|
| refractory UME patients treated with Conbercept | Experimental | patients in this arm should meet the inclusion criteria and the definition of refractory UME Receives: Drug: intravitreal injection of Conbercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of best corrected visual acuity (BCVA)
changes from baseline BCVA at 1, 2, 3, 4, 5, 6 months after injection (at each follow-up visit)
Measured: baseline and at 1, 2, 3, 4, 5, 6 months after injection
Changes of central retinal thickness (CRT)
changes from baseline CRT at 1, 2, 3, 4, 5, 6 months after injection (at each follow-up visit)
Measured: baseline and at 1, 2, 3, 4, 5, 6 months after injection
Secondary outcomes (4)
changes of concentration of inflammatory cytokines
inflammatory cytokines include VEGF-A, VEGF-B, interleukin (IL)-2, interleukin-6, interleukin-8, interleukin-10, interleukin-12, tumor necrosis factor (TNF) α, monocyte chemotactic protein-1 and macrophage inflammatory protein-1
Measured: before injection (baseline), 1 month after the first injection, at the end of the study (6 months)
inflammatory status
changes from baseline flare and cells in the anterior chamber at 1, 2, 3, 4, 5, 6 months after injection
Measured: baseline and at 1, 2, 3, 4, 5, 6 months after injection
side effects of the eye: increase of intraocular pressure
changes from baseline intraocular pressure at 1, 2, 3, 4, 5, 6 months after injection
Measured: baseline and at 1, 2, 3, 4, 5, 6 months after injection
side effects of the eye: development/exacerbation of cataract
whether cataract is developed or exacerbated
Measured: baseline and at 1, 2, 3, 4, 5, 6 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start12 Oct 2019
- Primary completion12 Apr 2020
- Study completion12 Feb 2022
Why it stopped: Due to inter-city travel restrictions for COVID-19, regular follow-up for most patients is not possible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Bethune public welfare fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296838
- Sponsor's protocol ID
- BJ-LM2018010J
- Status last verified
- Oct 2022
- First submitted
- 1 Jan 2020
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Conbercept in Treating Refractory Uveitic Macular Edema and the Changes of VEGF Levels in the Aqueous Humor
- ClinicalTrials.gov ID
- NCT04296838
- Acronym / sponsor ID
- BJ-LM2018010J
- Keywords
- Uveitis, Macular Edema, vascular endothelial growth factor, aqueous humor, Effect of Drugs
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to inter-city travel restrictions for COVID-19, regular follow-up for most patients is not possible
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Bethune public welfare fund
- Study start
- 12 Oct 2019 (actual)
- Primary completion
- 12 Apr 2020 (actual)
- Study completion
- 12 Feb 2022 (actual)
- First posted
- 5 Mar 2020 (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.
As a primary exploratory study, this study aims to evaluate the short-term effectiveness of intravitreal Conbercept injection in UME, and to explore the correlation between inflammatory factors like VEGF and the responsiveness to treatment.
Detailed description
Uveitic macular edema (UME) is one of the commonest and severest complications of chronic uveitis, and is also one of the important causes of permanent vision loss in uveitis. The pathophysiological mechanism of UME remains unclear, but was thought to be caused by damages of internal/external blood-retinal barrier mediated by inflammatory factors, including interleukin-2, interleukin-10, tumor necrosis factor α, prostaglandins and vascular endothelial growth factor (VEGF). Current treatments of UME include local or systemic glucocorticosteroids (GCS), immunosuppressants and biological agents. Although large dose of systemic GCS combined with immunosuppressants lead to quick resolution of ME in most of the cases, UME often relapse with tapering of GCS, and the side effects can be significant. Periocular or intraocular injection of GCS is effective in short term, but repetitive injections often lead to high intraocular pressure and cataract. Intravitreal injection of anti-VEGF agents is a huge advance of medical treatment in ophthalmology in recent years. Since 2007 till now, there have been a number of reports on the effectiveness of intraocular Bevacizumab and Ranibizumab injection in UME, but none about Conbercept. Besides, as the target of anti-VEGF agents, intraocular concentration of VEGF and its changes might be correlated to the sensitivity and responsiveness of UME to anti-VEGF agents, but has not been monitored. As a primary exploratory study, this study aims to evaluate the short-term effectiveness of intravitreal Conbercept injection in UME, and to explore the correlation between inflammatory factors like VEGF and the responsiveness to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| refractory UME patients treated with Conbercept | Experimental | Drug: intravitreal injection of Conberceptpatients in this arm should meet the inclusion criteria and the definition of refractory UME |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age >= 18 years old
- competent in signing the informed consent
- no severe systemic diseases unrelated to uveitis
- fulfill the criteria of refractory UME
Key exclusion criteria (5 listed)
- pregnant or preparing pregnancy
- already in other clinical trials
- blood pressure >= 180/110mmHg
- BCVA of the contralateral eye <= 20/200
- cardiovascular events within 3 months
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 |
|---|---|---|
| intravitreal injection of ConberceptAlso: Lumitinpatients will receive intravitreal injection of Conbercept, and at the same time, aqueous humor sample will be obtained from the anterior chamber to measure the concentrations of cytokines. | Drug | refractory UME patients treated with Conbercept |
Primary outcome
Changes of best corrected visual acuity (BCVA)
Time frame: baseline and at 1, 2, 3, 4, 5, 6 months after injection
changes from baseline BCVA at 1, 2, 3, 4, 5, 6 months after injection (at each follow-up visit)
Changes of central retinal thickness (CRT)
Time frame: baseline and at 1, 2, 3, 4, 5, 6 months after injection
changes from baseline CRT at 1, 2, 3, 4, 5, 6 months after injection (at each follow-up visit)
4 secondary outcomes
changes of concentration of inflammatory cytokines
Time frame: before injection (baseline), 1 month after the first injection, at the end of the study (6 months)
inflammatory status
Time frame: baseline and at 1, 2, 3, 4, 5, 6 months after injection
side effects of the eye: increase of intraocular pressure
Time frame: baseline and at 1, 2, 3, 4, 5, 6 months after injection
side effects of the eye: development/exacerbation of cataract
Time frame: baseline and at 1, 2, 3, 4, 5, 6 months after injection
Results and safety
The study was stopped early (reason given: Due to inter-city travel restrictions for COVID-19, regular follow-up for most patients is not possible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing intravitreal injection of Conbercept in people with Uveitis and Macular Edema, run by Peking Union Medical College Hospital 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: stopped early, as of the sponsor's last update on 25 Oct 2022. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Due to inter-city travel restrictions for COVID-19, regular follow-up for most patients is not possible). Results are not available in the source record.
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?
Changes of best corrected visual acuity (BCVA) (time frame: baseline and at 1, 2, 3, 4, 5, 6 months after injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2022.