Idiopathic Choroidal NeovascularizationPhase 2NCT02857517
Intravitreal Conbercept for Idiopathic Choroidal Neovascularization
A Phase 2 study testing conbercept in people with Idiopathic Choroidal Neovascularization, run by Jiao Mingfei at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy as primary treatment for ICNV. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Idiopathic Choroidal Neovascularization
- What is being tested?
- conbercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jun 2018
- Phase
- Phase 2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient who give voluntary signed informed consent
- Patient affiliated with the Tianjin Medical University Eye Hospital or similar
- Patient with ICNV with active primary subfoveal, retrofoveal or juxtafoveal lesions that affect the fovea as evidenced by angiography (fluorescein and/or indocyanin green) and/or SD-OCT in the studied eye
- Patient willing, committed and able to return for all clinic visits and complete all study-related procedures
Who cannot join
- Pregnant women
- Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study
- Patient who is protected adults according to the terms of the law (French public health laws)
- Involvement in another clinical trial (studied eye and/or the other eye)
- Patient with non-ICNV, especially:
- AMD
Show all 25Show fewer
- High myopia defined as refraction ≥ - 6 diopters
- Other curative treatment of ICNV in the studied eye during the last 3 months before the first intravitreal injection: anti-VEGF therapy, juxta- or extra-foveal macular laser, photodynamic therapy, surgery, external radiotherapy, transpupillary thermotherapy ...
- Medical history of retrofoveal focal macular laser photocoagulation in the studied eye
- Subretinal haemorrhage reaching the fovea centre, with a size > 50% of the lesion area
- Fibrosis or retrofoveal retinal atrophy in the studied eye
- Retinal pigment epithelial tear reaching the macula in the studied eye
- Medical history of intravitreal medical device in the studied eye
- Medical history of auto-immune or idiopathic uveitis
- Proved diabetic retinopathy
- Intra-ocular pressure ≥ 25 mmHg despite two topical hypotonic treatments
- Aphakia or lack of lens capsule (not removed by YAG laser) in the studied eye
- Arterial hypertension that is not controlled by an appropriate treatment
- Previous or actual treatment with systemic administration of anti-VEGF therapy
- Known hypersensitivity to aflibercept, or another drug composite of the medicinal product used; allergy to fluorescein, indocyanin green, anaesthetic eye drops
- Active or suspected ocular or peri-ocular infection
- Serious active intra-ocular inflammation in the studied eye
- Medical history of intra-ocular surgery within 28 days before the first injection in the studied eye
- Any illness or ocular condition that would require an intra-ocular surgery in the studied eye within 12 months after the inclusion
- Follow up not possible during 12 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300384
Mingfei Jiao, 18630956101, jiaomingfei2004@163.com
About this study
The purpose of this study is to evaluate the efficacy of intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy as primary treatment for ICNV.
- Conditions
- Idiopathic Choroidal Neovascularization
- Being tested
- conbercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conberceptDrug
Also called conbercept fusion protein
0.05ml conbercept
| Study group | Role | What they receive |
|---|---|---|
| intravitreal 0.05ml conbercept for ICNV | Experimental | 0.05ml conbercept ,1 injection with PRN Receives: Drug: conbercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity(Snellen chart)
Measured: baseline
visual acuity(Snellen chart)
Measured: Change from Baseline visual acuity at one day after injection
visual acuity(Snellen chart)
Measured: Change from Baseline visual acuity at one week after injection
visual acuity(Snellen chart)
Measured: Change from Baseline visual acuity at four weeks after injection
visual acuity
Measured: Change from Baseline visual acuity at eight weeks after injection
visual acuity(Snellen chart)
Measured: Change from Baseline visual acuity at 12weeks after injection
visual acuity(Snellen chart)
Measured: Change from Baseline visual acuity at half year after injection
visual acuity(Snellen chart)
Measured: Change from Baseline visual acuity at 1 year after injection
Secondary outcomes (6)
macular central fovea thickness(OCT)
Measured: baseline
macular central fovea thickness
Measured: Change from Baseline macular central fovea thickness at four weeks after injection
macular central fovea thickness(OCT)
Measured: Change from Baseline macular central fovea thickness at eight weeks after injection
macular central fovea thickness(OCT)
Measured: Change from Baseline macular central fovea thickness at 12 weeks after injection
macular central fovea thickness(OCT)
Measured: Change from Baseline macular central fovea thickness at half year after injection
macular central fovea thickness(OCT)
Measured: Change from Baseline macular central fovea thickness at 1 year 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 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Choroidal NeovascularizationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiao Mingfei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiao Mingfei, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857517
- Sponsor's protocol ID
- TJMUEH001
- Status last verified
- Aug 2016
- First submitted
- 27 Jul 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Conbercept for Idiopathic Choroidal Neovascularization
- ClinicalTrials.gov ID
- NCT02857517
- Acronym / sponsor ID
- TJMUEH001
- Conditions
- Idiopathic Choroidal Neovascularization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jiao MingfeiUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- First posted
- 5 Aug 2016 (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 evaluate the efficacy of intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy as primary treatment for ICNV.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intravitreal 0.05ml conbercept for ICNV | Experimental | Drug: conbercept0.05ml conbercept ,1 injection with PRN |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient who give voluntary signed informed consent
- Patient affiliated with the Tianjin Medical University Eye Hospital or similar
- Patient with ICNV with active primary subfoveal, retrofoveal or juxtafoveal lesions that affect the fovea as evidenced by angiography (fluorescein and/or indocyanin green) and/or SD-OCT in the studied eye
- Patient willing, committed and able to return for all clinic visits and complete all study-related procedures
Key exclusion criteria (25 listed)
- Pregnant women
- Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study
- Patient who is protected adults according to the terms of the law (French public health laws)
- Involvement in another clinical trial (studied eye and/or the other eye)
- Patient with non-ICNV, especially:
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 |
|---|---|---|
| conberceptAlso: conbercept fusion protein0.05ml conbercept | Drug | intravitreal 0.05ml conbercept for ICNV |
Primary outcome
visual acuity(Snellen chart)
Time frame: baseline
visual acuity(Snellen chart)
Time frame: Change from Baseline visual acuity at one day after injection
visual acuity(Snellen chart)
Time frame: Change from Baseline visual acuity at one week after injection
visual acuity(Snellen chart)
Time frame: Change from Baseline visual acuity at four weeks after injection
visual acuity
Time frame: Change from Baseline visual acuity at eight weeks after injection
visual acuity(Snellen chart)
Time frame: Change from Baseline visual acuity at 12weeks after injection
visual acuity(Snellen chart)
Time frame: Change from Baseline visual acuity at half year after injection
visual acuity(Snellen chart)
Time frame: Change from Baseline visual acuity at 1 year after injection
6 secondary outcomes
macular central fovea thickness(OCT)
Time frame: baseline
macular central fovea thickness
Time frame: Change from Baseline macular central fovea thickness at four weeks after injection
macular central fovea thickness(OCT)
Time frame: Change from Baseline macular central fovea thickness at eight weeks after injection
macular central fovea thickness(OCT)
Time frame: Change from Baseline macular central fovea thickness at 12 weeks after injection
macular central fovea thickness(OCT)
Time frame: Change from Baseline macular central fovea thickness at half year after injection
macular central fovea thickness(OCT)
Time frame: Change from Baseline macular central fovea thickness at 1 year after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing conbercept in people with Idiopathic Choroidal Neovascularization, run by Jiao Mingfei 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 25 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 11 Aug 2016. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mingfei Jiao, master (18630956101, jiaomingfei2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity(Snellen chart) (time frame: baseline). The study lists 8 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 11 Aug 2016.