Back to resultsConbercept in Choroidal Neovascularization Secondary to Uveitis
Primary Purpose
Choroidal Neovascularization, Uveitis
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Conbercept
sham
Sponsored by
About this trial
This is an interventional treatment trial for Choroidal Neovascularization
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Conbercept
sham
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Participants Who Gained at Least 15/10/5 Letters in BCVA as Measured by ETDRS at month 12
Percentage of Participants Who Gained at Least 15/10/5 Letters in BCVA as Measured by ETDRS at 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
Percentage of Participants Who Lost at Least 15/10/5 Letters in BCVA Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) at month 12
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) at every visit
Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to month 3/6/12
Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to month 12
Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to month 12
Mean Change in Area of Leakage assessed by FFA From Baseline at month 3\6\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
Full Information
NCT ID
NCT02934841
First Posted
October 13, 2016
Last Updated
October 13, 2016
Sponsor
Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02934841
Brief Title
Conbercept in Choroidal Neovascularization Secondary to Uveitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chongqing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Neovascularization, Uveitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conbercept
Arm Type
Experimental
Arm Description
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.
Arm Title
sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Conbercept
Intervention Type
Drug
Intervention Name(s)
sham
Primary Outcome Measure Information:
Title
Mean Change in Best Corrected Visual Acuity (BCVA)Measured by Early Treatment Diabetic Retinopathy Study (ETDRS)at every visit
Description
Compare of mean BCVA at every visit between the two groups to assess the efficacy of conbercept.
Time Frame
From Baseline to month 12
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) at every visit
Time Frame
12 months
Title
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
Title
Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to month 12
Time Frame
Baseline, month 12
Title
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
Title
Mean Change in Area of Leakage assessed by FFA From Baseline at month 3\6\12
Time Frame
Baseline, month 3, 6 and 12
Title
Number of participants with adverse events
Description
Compare of Number of participants with adverse events between the two groups to assess the safety of conbercept
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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,
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shulin Liu
Phone
+86 02389012010
Email
shulinliu_cmu@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Conbercept in Choroidal Neovascularization Secondary to Uveitis
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