Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conbercept | Drug |
| ||
| sham |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline to month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Gained at Least 15/10/5 Letters in BCVA as Measured by ETDRS at month 12 | Baseline, month 12 | |
| Percentage of Participants Who Gained at Least 15/10/5 Letters in BCVA as Measured by ETDRS at month 6 | Baseline, month 6 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shulin Liu | Contact | +86 02389012010 | shulinliu_cmu@163.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
Not provided
Not provided
| ID | Term |
|---|---|
| C527363 | KH902 fusion protein |
| C005703 | salicylhydroxamic acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Percentage of Participants Who Lost at Least 15/10/5 Letters in BCVA Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) at month 6 | 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 | Baseline, month 12 |
| Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) at every visit | 12 months |
| Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to month 3/6/12 | Baseline, month 3, 6 and 12 |
| Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to month 12 | Baseline, month 12 |
| Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to month 12 | Baseline, month 12 |
| Mean Change in Area of Leakage assessed by FFA From Baseline at month 3\6\12 | 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 | 12 months |
| D008679 |
| Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |