Choroid Neovascularization Secondary to Degenerative Myopia
Conditions
Brief summary
This study is design to evaluate the effect of conbercept therapy on visual acuity and anatomic outcomes compared to sham injection and durability of response observed in subjects with choroid neovascularization secondary to pathological myopia.
Interventions
DRUGconbercept, Fixed
intravitreal injection of 0.5 mg conbercept per month, fixed injection
DRUGconbercept, PRN
intravitreal injection of 0.5 mg conbercept as need, PRN
OTHERsham injection
sham intravitreal injection per month, fixed injection
Sponsors
Chengdu Kanghong Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients give fully informed consent and are willing and able to comply with all study procedures. 2. In the study eye: * Myopia of equal to or greater than -6.00D,and axial length ≥26.5mm. * Diagnosis of active subfoveal, juxafoveal, or extrafoveal CNV secondary to high myopia. * Visual impairment due to CNV secondary to high myopia. * BCVA score ≥24 and ≤73 ETDRS letters (approximately 20/40\ 20/320 Snellen equivalent). * Ocular media of sufficient quality to obtain fundus and OCT images. 3. The BCVA score of fellow eyes ≥ 19 ETDRS letters (approximately 20/400 Snellen equivalent)
Exclusion criteria
1. Current vitreous hemorrhage in either eye. 2. Intraocular treatment with corticosteroids within last 3 months or periocular treatment with corticosteroids within last month in the study eye. 3. Active infectious ocular inflammation in either eye. 4. Fibrosis or atrophy involving the center of foveal in the study eye. 5. Any concurrent intraocular condition in the study eye that, in the opinion of investigator, could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition. 6. The lesion size ≥30 mm2 in the study eye. 7. Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results. 8. Uncontrolled glaucoma or cup/disk ratio \> 0.8 in the study eye. 9. Aphakia (excluding artificial lens) in the study eye. 10. Serious amblyopia and amaurosis in the fellow eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean change from baseline of visual acuity | 3-month | to compare the mean change from baseline of best-corrected visual acuity (BCVA) between conbercept treatment group and sham injection group at month 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean change from baseline of anatomical features | 3-month | to compare the difference of mean change from baseline of CRT, CNV size and lesion size between conbercept treatment group and sham injection group at month 3 |
| mean change from baseline of visual acuity | 9 months | to evaluate the mean change from baseline of BCVA of two groups from month 1 to month 9 |
| safety and tolerability of conbercept | 3-month and 9-month | to evaluate the incidence of AEs (ocular or non-ocular) of two groups at month 3 and 9 |
Countries
China
Outcome results
None listed