Choroidal NeovascularizationPhase 2NCT02934841
Conbercept in Choroidal Neovascularization Secondary to Uveitis
A Phase 2 study testing Conbercept in people with Choroidal Neovascularization and Uveitis, run by Chongqing Medical University.
Trial summary
The investigators hypothesize that it is safe and effective to treat patients with choroidal neovascularisation (abnormal blood vessels growing under the retina) secondary to uveitis with Conbercept. This will be a randomized, placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Choroidal Neovascularization, Uveitis
- What is being tested?
- Conbercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with uveitis (without signs of active uveitis) related CNV, whatever the cause, including multifocal choroiditis, punctate inner choroidopathy, ocular toxoplasmosis, serpiginous choroiditis, Birdshot chorioretinopathy or VKH syndrome, etc, with active primary subfoveal, retrofoveal or juxtafoveal lesions that affect the fovea as evidenced by angiography and/or OCT in the studied eye
- Total lesion area < 12 disc areas.
- Total area of CNV within the lesion must be > 50% of total lesion.
- Best corrected visual acuity of 20/40 to 20/320 in the study eye.
- Willing and able to give informed consent.
Who cannot join
- Prior treatment in the study eye with, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy or other anti VEGF treatments,
- History of submacular surgery or other surgical intervention in the study eye, glaucoma filtration surgery, corneal transplant surgery,
- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding baseline,
- Extracapsular extraction of cataract with phacoemulsification within three months preceding baseline, or a history of post-operative complications within the last 12 months preceding baseline in the study eye (uveitis, cyclitis, etc.),
- History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication),
- Aphakia with absence of the posterior capsule in the study eye,
Show all 11Show fewer
- Active intraocular inflammation (grade trace or above) in the study eye,
- Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis,
- Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye,
- Presence of a retinal pigment epithelial tear involving the macula in the study eye,
- Subfoveal fibrosis or atrophy in the study eye.
Trial locations and contacts
No sites are listed yet.
About this study
The investigators hypothesize that it is safe and effective to treat patients with choroidal neovascularisation (abnormal blood vessels growing under the retina) secondary to uveitis with Conbercept.
This will be a randomized, placebo-controlled trial. 20 patients will receive three injections of Conbercept into the affected eye (and repeated injections if required), and 20 patients will receive three sham injections requiring no needle stick, but making the patient unaware of whether or not he received active treatment.
Outcome of the two treatment groups will be compared after one year.
Read the detailed description
Primary Outcome Measures: Mean change from baseline in best corrected visual acuity [ Time Frame: 12 months ]
Secondary Outcome Measures: Mean change from baseline in retinal thickness [ Time Frame: 12 months ]
Mean number of Conbercept injections required over 12 months [ Time Frame: 12 months ]
Ocular and systemic adverse events [ Time Frame: 12 months ]
Enrollment: 40
Intervention Details: Drug: Conbercept
20 patients will receive an intravitreal injections of conbercept 0.5 mg at baseline (visit 1; month 0) then a subsequent intravitreal injection at month 1 (visit 2) and month 2 (Visit 3). Patients will be reviewed every month thereafter for 12 months at which time it will be determined whether the patient requires retreatment with conbercept 0.5 mg based on measurements of visual acuity, Optical coherence tomography (OCT) findings, FFA and clinical appearance.
- Conditions
- Choroidal Neovascularization, Uveitis
- Being tested
- Conbercept, sham
- Medical subject headings
- Choroidal Neovascularization, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConberceptDrug
shamDrug
| Study group | Role | What they receive |
|---|---|---|
| Conbercept | Experimental | The patients are followed on a monthly basis until 12 months. Three intravitreal injections of conbercept at a dosage of 0.5 mg are initiated at inclusion (monthly) with reinjection every month only in case of CNV activity (PRN regimen) until 12 months. Receives: Drug: Conbercept |
| sham | Sham comparator | The patients are followed on a monthly basis until 12 months. Three intravitreal sham injections are initiated at inclusion (monthly) with reinjection every month only in case of CNV activity (PRN regimen) until 12 months. Receives: Drug: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Best Corrected Visual Acuity (BCVA)Measured by Early Treatment Diabetic Retinopathy Study (ETDRS)at every visit
Compare of mean BCVA at every visit between the two groups to assess the efficacy of conbercept.
Measured: From Baseline to month 12
Secondary outcomes (10)
Percentage of Participants Who Gained at Least 15/10/5 Letters in BCVA as Measured by ETDRS at month 12
Measured: Baseline, month 12
Percentage of Participants Who Gained at Least 15/10/5 Letters in BCVA as Measured by ETDRS at month 6
Measured: Baseline, month 6
Percentage of Participants Who Lost at Least 15/10/5 Letters in BCVA Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) at month 6
Measured: Baseline, month 6
Percentage of Participants Who Lost at Least 15/10/5 Letters in BCVA Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) at month 12
Measured: Baseline, month 12
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) at every visit
Measured: 12 months
Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to month 3/6/12
Measured: Baseline, month 3, 6 and 12
Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to month 12
Measured: Baseline, month 12
Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to month 12
Measured: Baseline, month 12
Mean Change in Area of Leakage assessed by FFA From Baseline at month 3\6\12
Measured: Baseline, month 3, 6 and 12
Number of participants with adverse events
Compare of Number of participants with adverse events between the two groups to assess the safety of conbercept
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shulin Liu, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934841
- Sponsor's protocol ID
- BQE-10
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2016
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conbercept in Choroidal Neovascularization Secondary to Uveitis
- ClinicalTrials.gov ID
- NCT02934841
- Acronym / sponsor ID
- BQE-10
- Conditions
- Choroidal Neovascularization, Uveitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 17 Oct 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 investigators hypothesize that it is safe and effective to treat patients with choroidal neovascularisation (abnormal blood vessels growing under the retina) secondary to uveitis with Conbercept.
This will be a randomized, placebo-controlled trial. 20 patients will receive three injections of Conbercept into the affected eye (and repeated injections if required), and 20 patients will receive three sham injections requiring no needle stick, but making the patient unaware of whether or not he received active treatment.
Outcome of the two treatment groups will be compared after one year.
Detailed description
Primary Outcome Measures: Mean change from baseline in best corrected visual acuity [ Time Frame: 12 months ]
Secondary Outcome Measures: Mean change from baseline in retinal thickness [ Time Frame: 12 months ]
Mean number of Conbercept injections required over 12 months [ Time Frame: 12 months ]
Ocular and systemic adverse events [ Time Frame: 12 months ]
Enrollment: 40
Intervention Details: Drug: Conbercept
20 patients will receive an intravitreal injections of conbercept 0.5 mg at baseline (visit 1; month 0) then a subsequent intravitreal injection at month 1 (visit 2) and month 2 (Visit 3). Patients will be reviewed every month thereafter for 12 months at which time it will be determined whether the patient requires retreatment with conbercept 0.5 mg based on measurements of visual acuity, Optical coherence tomography (OCT) findings, FFA and clinical appearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conbercept | Experimental | Drug: ConberceptThe patients are followed on a monthly basis until 12 months. Three intravitreal injections of conbercept at a dosage of 0.5 mg are initiated at inclusion (monthly) with reinjection every month only in case of CNV activity (PRN regimen) until 12 months. |
| sham | Sham comparator | Drug: shamThe patients are followed on a monthly basis until 12 months. Three intravitreal sham injections are initiated at inclusion (monthly) with reinjection every month only in case of CNV activity (PRN regimen) until 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with uveitis (without signs of active uveitis) related CNV, whatever the cause, including multifocal choroiditis, punctate inner choroidopathy, ocular toxoplasmosis, serpiginous choroiditis, Birdshot chorioretinopathy or VKH syndrome, etc, with active primary subfoveal, retrofoveal or juxtafoveal lesions that affect the fovea as evidenced by angiography and/or OCT in the studied eye
- Total lesion area < 12 disc areas.
- Total area of CNV within the lesion must be > 50% of total lesion.
- Best corrected visual acuity of 20/40 to 20/320 in the study eye.
- Willing and able to give informed consent.
Key exclusion criteria (11 listed)
- Prior treatment in the study eye with, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy or other anti VEGF treatments,
- History of submacular surgery or other surgical intervention in the study eye, glaucoma filtration surgery, corneal transplant surgery,
- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding baseline,
- Extracapsular extraction of cataract with phacoemulsification within three months preceding baseline, or a history of post-operative complications within the last 12 months preceding baseline in the study eye (uveitis, cyclitis, etc.),
- History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication),
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 |
|---|---|---|
| Conbercept | Drug | Conbercept |
| sham | Drug | sham |
Primary outcome
Mean Change in Best Corrected Visual Acuity (BCVA)Measured by Early Treatment Diabetic Retinopathy Study (ETDRS)at every visit
Time frame: From Baseline to month 12
Compare of mean BCVA at every visit between the two groups to assess the efficacy of conbercept.
10 secondary outcomes
Percentage of Participants Who Gained at Least 15/10/5 Letters in BCVA as Measured by ETDRS at month 12
Time frame: Baseline, month 12
Percentage of Participants Who Gained at Least 15/10/5 Letters in BCVA as Measured by ETDRS at month 6
Time frame: Baseline, month 6
Percentage of Participants Who Lost at Least 15/10/5 Letters in BCVA Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) at month 6
Time frame: Baseline, month 6
Percentage of Participants Who Lost at Least 15/10/5 Letters in BCVA Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) at month 12
Time frame: Baseline, month 12
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) at every visit
Time frame: 12 months
Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to month 3/6/12
Time frame: Baseline, month 3, 6 and 12
Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to month 12
Time frame: Baseline, month 12
Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to month 12
Time frame: Baseline, month 12
Mean Change in Area of Leakage assessed by FFA From Baseline at month 3\6\12
Time frame: Baseline, month 3, 6 and 12
Number of participants with adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conbercept in people with Choroidal Neovascularization and Uveitis, run by Chongqing Medical University.
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 11 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 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Shulin Liu (+86 02389012010, shulinliu_cmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Best Corrected Visual Acuity (BCVA)Measured by Early Treatment Diabetic Retinopathy Study (ETDRS)at every visit (time frame: From Baseline to month 12). 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 17 Oct 2016.