Circumscribed Choroidal HaemangiomaEarly Phase 1NCT03571282
Safety and Effectiveness of Intravitreal Conbercept for Exudative Circumscribed Choroidal Haemangioma
A Early Phase 1 study testing conbercept in people with Circumscribed Choroidal Haemangioma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Circumscribed Choroidal Haemangioma
- 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
- 6 Jun 2018to 6 Jun 2019
- 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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1) patients with circumscribed choroidal haemangioma who was diagnosed using ophthalmoscopy, fluorescein/indocyanine green angiography, and ultrasonography; 2) presence of reduced visual acuity or metamorphopsia; and 3) subretinal fluid involving the fovea.
Who cannot join
- patients with abnormal liver function test results, liver disease, porphyria, or previous treatment for circumscribed choroidal haemangioma.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Jiawei Wang, 020-87331359
Chenjin Jin, 13302209900
About this study
Official title: Safety and Effectiveness Study of Intravitreal Conbercept Injection for Exudative Circumscribed Choroidal Haemangioma
This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.
Read the detailed description
This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma: (1)To evaluate therapeutic effect (including both anatomical and functional responses to intravitreal conbercept injection) of intravitreal conbercept injectionfor exudative circumscribed choroidal haemangioma; (2)To evaluate the safety (including side effects of the eye as well as side effects of system) of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.
- Conditions
- Circumscribed Choroidal Haemangioma
- Being tested
- conbercept
- Keywords
- conbercept, circumscribed choroidal haemangioma, safety, effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conberceptDrug
Also called photodynamic therapy, laser photocoagulation
After three monthly injections of conbercept, if no effects was seen in the patients, the patients will receive rescue treatments such as photodynamic therapy (in the macular) or laser photocoagulation (outside the macular).
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | The patients in the treatment group receive three monthly intravitreal injection of conbercept followed by PRN rescue treatments such as intravitreal injection of conbercept, laser photocoagulation (when outside the macular) or photodynamic therapy (when in the macular). Receives: Drug: conbercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity
change of best corrected visual acuity
Measured: half a year
Secondary outcomes (1)
Central foveal thickness
change of central foveal thickness
Measured: half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start6 Jun 2018
- Primary completion6 Jun 2019 (estimated)
- Study completion6 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circumscribed Choroidal HaemangiomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Chen-jin, Sun Yat-sen University
- Investigators
- Chenjin Jin, Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571282
- Sponsor's protocol ID
- 2018KYPJ081
- Status last verified
- Jun 2018
- First submitted
- 16 Jun 2018
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Study of Intravitreal Conbercept Injection for Exudative Circumscribed Choroidal Haemangioma
- ClinicalTrials.gov ID
- NCT03571282
- Acronym / sponsor ID
- 2018KYPJ081
- Conditions
- Circumscribed Choroidal Haemangioma
- Keywords
- conbercept, circumscribed choroidal haemangioma, safety, effectiveness
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 6 Jun 2019 (estimated)
- Study completion
- 6 Jun 2019 (estimated)
- First posted
- 27 Jun 2018 (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.
This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.
Detailed description
This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma: (1)To evaluate therapeutic effect (including both anatomical and functional responses to intravitreal conbercept injection) of intravitreal conbercept injectionfor exudative circumscribed choroidal haemangioma; (2)To evaluate the safety (including side effects of the eye as well as side effects of system) of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: conberceptThe patients in the treatment group receive three monthly intravitreal injection of conbercept followed by PRN rescue treatments such as intravitreal injection of conbercept, laser photocoagulation (when outside the macular) or photodynamic therapy (when in the macular). |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1) patients with circumscribed choroidal haemangioma who was diagnosed using ophthalmoscopy, fluorescein/indocyanine green angiography, and ultrasonography; 2) presence of reduced visual acuity or metamorphopsia; and 3) subretinal fluid involving the fovea.
Key exclusion criteria (1 listed)
- patients with abnormal liver function test results, liver disease, porphyria, or previous treatment for circumscribed choroidal haemangioma.
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: photodynamic therapy, laser photocoagulationAfter three monthly injections of conbercept, if no effects was seen in the patients, the patients will receive rescue treatments such as photodynamic therapy (in the macular) or laser photocoagulation (outside the macular). | Drug | treatment group |
Primary outcome
Best-corrected visual acuity
Time frame: half a year
change of best corrected visual acuity
1 secondary outcome
Central foveal thickness
Time frame: half a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Individual participant dataSharing planned: Undecided
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.
Chenjin Jin, 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 conbercept in people with Circumscribed Choroidal Haemangioma, run by Sun Yat-sen 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 1 inclusion and 1 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 27 Jun 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kunbei Lai, ph.D. (8602087331366, laikb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity (time frame: half a year). 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 27 Jun 2018.