Conbercept Ophthalmic Injection for Patients With Macular Edema Caused by Branch Retinal Vein Occlusion
BRAVE
Multi-center, Randomized, Double-masked, Placebo-controlled Phase III Clinical Study of Conbercept Ophthalmic Injection for Patients With BRVO.
1 other identifier
interventional
255
1 country
31
Brief Summary
The purpose of this study is to verify the efficacy and safety of intravitreal injection of conbercept in patients with macular edema (ME) caused by branch retinal vein occlusion (BRVO).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2016
Longer than P75 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 13, 2016
CompletedFirst Submitted
Initial submission to the registry
February 8, 2017
CompletedFirst Posted
Study publicly available on registry
April 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2020
CompletedJuly 15, 2022
July 1, 2022
4 years
February 8, 2017
July 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Best Corrected Visual Acuity
Compare mean changes in Best Corrected Visual Acuity (BCVA) from baseline between the Conbercept ophthalmic injection treatment group (treatment group) and the control group at month 6.
month 6
Secondary Outcomes (7)
Best Corrected Visual Acuity (BCVA)
month 3 and month 12
Central Retinal Thickness
month 3, month 6 and month 12
resue treament
month 6 and month 12
Number of participants with treatment-related the systemic and ocular safely as assessed
up to 12.5 months
distribution of BCVA changes
month 3, month 6 and month 12
- +2 more secondary outcomes
Other Outcomes (5)
Immunogenic positive response in the treatment group
baseline,month 6, month 12
Immunogenic positive response in the control group
baseline,month 6, month 12
safety analysis of immunogenic positive response
month 12
- +2 more other outcomes
Study Arms (2)
Conbercept ophthalmic injection
EXPERIMENTALConbercept ophthalmic injection
Sham Comparator
SHAM COMPARATORsham / Conbercept ophthalmic injection
Interventions
Conbercept ophthalmic injection at a dose of 0.5 mg every month(day0-month 5); If sbujects meets the criteria for repeated administration, the subject receives 0.5 mg Conbercept injection into the study eye (Month 6 \~ 11)
Sham injection every month (Day 0 - Month 5); 0.5 mg Conbercept ophthalmic injection in month 6; If sbujects meets the criteria for repeated administration, the subject receives 0.5 mg Conbercept injection into the study eye (Month 7 \~ 11)
Eligibility Criteria
You may qualify if:
- Patients have signed informed consent form and agreed to be followed up as per the trial protocol;
- Aged ≥ 18 years, male or female;
- Study eyes must meet all of following requirements:
- Suffering from macular edema secondary to BRVO that involves the fovea and BRVO has been first diagnosed within previous 12 months;
- Best corrected visual acuity (BCVA) ≥24 and ≤73 letters (Snellen equivalent is 20/320 - 20/40);
- Central retinal thickness (CRT) on OCT is ≥300 μm;
- Without opacities in the refractive media and pupillary miosis that affects fundus examination.
You may not qualify if:
- Any subject who has any of the following ocular condition:
- Eye of interest
- Has active retina and/or iris neovascularization;
- Has macular epiretinal membranes or vitreous tractions which are considered to influence the central visual acuity by the researcher;
- Has other diseases which are considered to influence the macular functional recovery by the researcher, e.g., foveal atrophy, subfoveal hemorrhage, macular hard exudates or dense submacular hard exudates;
- Has a history of any type of retinal detachment;
- Has non-RVO ocular diseases which are considered to possibly cause macular edema, declined visual acuity or retinal neovascularization during the study period by the researcher, e.g., wet AMD, diabetic retinopathy, uveitis/other intraocular inflammatory diseases, neovascular glaucoma and cystoid macular edema;
- Is considered to require cataract surgery in the next 12 months by the researcher;
- Has received intravitreal injection of corticosteroids within three months before screening, subconjunctival injection of corticosteroids within six months, or local treatment with ocular corticosteroids within one month;
- Has received the following ophthalmic operations: scleral buckling, verteporfin-photodynamic therapy (PDT), vitrectomy, radial optic neurotomy/optic nerve sheathotomy, glaucoma filtration, parafoveal laser photocoagulation, pan-retinal photocoagulation, and macular translocation;
- Has received YAG laser treatment or any other ophthalmic treatments (including cataract surgery, macular grid laser photocoagulation, local retinal photocoagulation, and keratoplasty) within three months before screening;
- Has a BCVA increment by more than 10 alphabets during the screening period (BCVA tested within 24 hours before medication at Day 0 versus BCVA at the time of screening);
- Has aphakic eye (excluding pseudophakic) or or posterior lens capsule (except YAG laser posterior capsulotomy after intraocular lens implantation);
- Either eye:
- Has active periocular or ocular inflammation (e.g., blepharitis, infective conjunctivitis, keratitis, scleritis, uveitis, and endophthalmitis);
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
The Second Hospital of Jilin University
Changchun, China
The Second Xiangya Hospital of Central South University
Changsha, China
West China Hospital Sichuan University
Chengdu, China
Army Medical Center
Chongqing, China
The Second Hospital of Dalian Medical University
Dalian, China
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, China
The Jiangxi Provincial People's Hospital
Nanchang, China
Jiangsu Province Hospital
Nanjing, China
Nanjing First Hospital
Nanjing, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
Eye & Ent Hospital of Fudan University
Shanghai, China
Shanghai General Hospital
Shanghai, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Zhongshan Hospital
Shanghai, China
The First Hospital of China Medical University
Shenyang, China
Tianjin Medical University Eye Hospital School of Optometry & Eye Institute
Tianjin, China
Tianjin Eye Hospital
Tianjing, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China
Eye Hospital,WMU Zhejiang Eye Hospital
Wenzhou, China
Wuhan General Hospital of Guangzhou Military Command
Wuhan, China
Wuxi No.2 People's Hospital
Wuxi, China
The First Affiliated Hospital of Xi'An
Xi'an, China
Related Publications (1)
Shalchi Z, Mahroo O, Bunce C, Mitry D. Anti-vascular endothelial growth factor for macular oedema secondary to branch retinal vein occlusion. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD009510. doi: 10.1002/14651858.CD009510.pub3.
PMID: 32633861DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2017
First Posted
April 11, 2017
Study Start
April 13, 2016
Primary Completion
April 13, 2020
Study Completion
October 16, 2020
Last Updated
July 15, 2022
Record last verified: 2022-07