Choroid Neovascularization Secondary to Degenerative Myopia Clinical Trial
— SHINYOfficial title:
The Safety and Efficacy of Conbercept in the Treatment of Choroidal Neovascularization (CNV) Secondary to High Myopia
| Verified date | March 2014 |
| Source | Chengdu Kanghong Biotech Co.,Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 176 |
| Est. completion date | March 2015 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Tongren hospital affiliated to Capital Medical University | Beijing | Beijing |
| China | Peking Union Medical College Hospital | Beijing | Beijing |
| China | Peking University Third Hospital | Beijing | Beijing |
| China | West China Hospital of Sichuan University | Chengdu | Sichuan |
| China | Daping Hospital, Research Institute of Surgery Third Military Medical University | Chongqing | Chongqing |
| China | Southwest Hospital | Chongqing | Chongqing |
| China | Zhongshan Ophthalmic Center | Guangzhou | Guangdong |
| China | Ophthalmologic Hospital of Qingdao | Qingdao | Shandong |
| China | Shanghai First People's Hospital | Shanghai | Shanghai |
| China | The Affiliated Eye Hospital of WMC | Wenzhou | Zhejiang |
| China | Wuhan General Hospital of Guangzhou Military | Wuhan | Hubei |
| China | Wuxi No.2 People's Hospital | Wuxi | Jiangsu |
| China | Xijing Hospital | Xian | Shanxi |
| Lead Sponsor | Collaborator |
|---|---|
| Chengdu Kanghong Biotech Co.,Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | mean change from baseline of visual acuity | to compare the mean change from baseline of best-corrected visual acuity (BCVA) between conbercept treatment group and sham injection group at month 3 | 3-month | No |
| Secondary | mean change from baseline of anatomical features | 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 | 3-month | No |
| Secondary | mean change from baseline of visual acuity | to evaluate the mean change from baseline of BCVA of two groups from month 1 to month 9 | 9 months | No |
| Secondary | safety and tolerability of conbercept | to evaluate the incidence of AEs (ocular or non-ocular) of two groups at month 3 and 9 | 3-month and 9-month | Yes |