Efficacy and Safety of "Treat-and-Extend" Regimen Versus "Pro Re Nata" of Conbercept in Age-related Macular Degeneration
- Conditions
- Age-related Macular Degeneration
- Interventions
- Registration Number
- NCT02802657
- Lead Sponsor
- Xiaodong Sun
- Brief Summary
The study will evaluate the efficacy and safety of two different regimens of Conbercept (Treat-and-Extend (T\&E) Regimen vs. Pro Re Nata (PRN)) in patients with wet AMD. This study is to provide long-term safety data in the treatment of patients with wet Age-related Macular Degeneration (AMD).
- Detailed Description
Participants with wAMD were randomized and received a T\&E or PRN regimen for 24 months. Mean Snellen BCVA and mean central macular thickness by OCT were examined at each visit. Any treatment-related adverse events, such as endophthalmitis, and systemic adverse events, such as stroke, were evaluated during the research.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 141
- Written informed-consent before any evaluation
- Visual impairment due to active CNV,including predominantly classic CNV,minimally classic CNV,occult CNV with no classic component and PCV.
- 50 years old and older
- Chinese
- For study eye: BCVA between 20/30 and 20/320 on electronic visual acuity texting at the time point of both screening and baseline.
- Have Stroke and myocardial infarction within 3 months before screening
- Any active periocular and ocular infection and inflammation (including blepharitis, conjunctivitis, keratitis, scleritis, uveitis, intraocular inflammation) while screening and baseline.
- Uncontrolled glaucoma (under treatment [IOP] ≥ 30 mm Hg or depend on researchers) while screening and baseline
- Neovascularization of iris and neovascular glaucoma while screening and baseline
- Any causes led to choroidal neovascularization except Wet AMD (including ICNV,central serous chorioretinopathy,ocular histoplazmoza and pathologic myopia) while screening and baseline
- With structure injury (including vitreous macular traction,epiretinal membrane involving in central fovea,subretinal fibroplasia,laser scar and central fovea atrophy) within 0.5 optic disc diameter to the central of macula while screening and baseline, which may harm the improvement of vision by treatment according to researchers
- Any systemic anti-VEGF medication(as Avastin) use within 3 months before screening
- Any medication systemic use toxic to lens, retina and optic nerve,including iron amine, chloroquine/chloroquine (Plaquenil ®), tamoxifen, phenothiazine and ethambutol
- For study eye：Used to accept following treatments for wet AMD within 3 months or accept following treatments more than three times before baseline: a)Anti-angiogenesis drugs(pegaptanib （Macugen®），ranibizumab ,bevacizumab（Avastin®),VEGF-Trap，KH902；b）Anecortave acetate corticosteroids；c）Protein kinase C inhibitors，squalamine，siRNA; d)PDT （Visudyne®）treatment,external beam radiotherapy, local laser photocoagulation, vitrectomy, submacular surgery and transpupillary thermotherapy
- Any intraocular surgery(including YAG laser) within 3 months before baseline or predicated within 6 months after baseline
- Intraocular or periocular treatment of corticosteroids within 3 months before baseline
- For follow eye:Any anti-angiogenesis treatment(including anti-VEGF,like Lucentis,Avastin® and KH902 ) within 3 months before baseline
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conbercept 0.5mg Treat-and-Extend regimen Treat-and-Extend regimen Monthly intravitreal injections of Conbercept 0.5mg in the core treatment period and Treat-and-Extend Regimen of the same dose guided by BCVA stabilization and optical coherence tomography (OCT) in the extension treatment period. Intervention: Drug: Conbercept Conbercept 0.5mg Pro Re Nata Pro Re Nata Monthly intravitreal injections of Conbercept 0.5mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period. Intervention: Drug: Conbercept Conbercept 0.5mg Treat-and-Extend regimen Conbercept Monthly intravitreal injections of Conbercept 0.5mg in the core treatment period and Treat-and-Extend Regimen of the same dose guided by BCVA stabilization and optical coherence tomography (OCT) in the extension treatment period. Intervention: Drug: Conbercept Conbercept 0.5mg Pro Re Nata Conbercept Monthly intravitreal injections of Conbercept 0.5mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period. Intervention: Drug: Conbercept
- Primary Outcome Measures
Name Time Method Mean Snellen BCVA at every visit or treatment 24 months Compare of mean Snellen Best-Corrected-visual-acuity at every visit or treatment between the two groups to assess the efficacy of Treat-and-Extend regimen of Conbercept.
- Secondary Outcome Measures
Name Time Method Mean number of injections after the initial three loading dose monthly injections 21 months Compare of mean number of injections after the initial three loading dose monthly injections between the two groups to assess the efficacy of Treat-and-Extend regimen of Conbercept.
Number of participants with treatment-related adverse events 24 months Compare of Number of participants with treatment-related adverse events between the two groups to assess the safety of Treat-and-Extend regimen of Conbercept
mean central macular thickness at every visit or treatment by OCT 24 months Compare of mean central macular thickness by OCT at every visit or treatment between the two groups to assess the efficacy of Treat-and-Extend regimen of Conbercept.
Trial Locations
- Locations (5)
Shanghai Tongji Hospital, Tongji University School of Medicine
🇨🇳Shanghai, China
Eye & Ent Hospital of Fudan University
🇨🇳Shanghai, China
Shanghai Zhongshan Hospital
🇨🇳Shanghai, China
Shanghai First People's Hospital
🇨🇳Shanghai, China
Central Theater Command General Hospital
🇨🇳Wuhan, Hubei, China