Conbercept Ophthalmic Injection for Patients of Central Retinal Vein Occlusion
CRAVE
An Efficacy and Safety Trial of Intravitreal Injection of Conbercept Ophthalmic Injection in Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion
1 other identifier
interventional
242
1 country
27
Brief Summary
This study evaluates the efficacy and safety of Conbercept ophthalmic injection. This is a multi-center, randomized, double-masked, placebo-controlled phase III clinical study. 237 patients with central retinal vein occlusion(CRVO) are expected to be enrolled in the study and randomly assigned into the Conbercept ophthalmic injection treatment group or the control group at a ratio of 2:1.
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 May 2016
Typical duration for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 24, 2016
CompletedFirst Submitted
Initial submission to the registry
February 8, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2020
CompletedJuly 13, 2022
July 1, 2022
3.9 years
February 8, 2017
July 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Corrected Visual Acuity
To 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 (4)
Best Corrected Visual Acuity
month 3 and month 12
Central Retinal Thickness
month 3, month6 and month 12
Number of subject who received laser rescue treatment
month 6 and month 12
Number of participants with treatment-related the systemic and ocular safely as assessed
month 6 and month 12 or trail period
Other Outcomes (3)
distribution of BCVA changes
month 3, month 6 and month 12
Mean change in Best Corrected Visual Acuity
month 0,month 1,month 2,month 3,month 4,month 5,month 6,month 7,month 8,month 9,month 10,month 11 and month 12
Mean changes in CRT, Macular Volume
month 0,month 1,month 2,month 3,month 4,month 5,month 6,month 7,month 8,month 9,month 10,month 11 and month 12
Study Arms (2)
Conbercept
EXPERIMENTALConbercept
Conbercept or sham
SHAM COMPARATORConbercept or sham
Interventions
Subject receive 0.5 mg Conbercept injection into their study eyes every month (Day 0 - Month 5). If subjects meets the criteria for repeated administration, the subject receives 0.5 mg Conbercept injection into the study eye (Month 6 \~ 11).
Subjects receive sham injection into their study eyes every month (Day 0 - Month 5). Subjects receive a single intravitreal injection of 0.5 mg Conbercept ophthalmic injection in month 6, followed monthly review, if he/she meets the criteria for repeated administration, the subject receives 0.5 mg Conbercept injection into the study eye (Month 6 \~ 11).
Eligibility Criteria
You may qualify if:
- Patients have signed informed consent and agreed to be followed up as per the trial protocol;
- Aged ≥ 18 years, male or female;
- Target eyes must meet all of following requirements:
- Suffering from macular edema secondary to CRVO or HRVO that involves the fovea and 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:
- Patients who present with any the following ocular conditions:
- \- Study eyes
- Active retinal or iris neovascularization;
- Epiretinal membrane or vitreomacular traction that investigators consider likely to affect central vision;
- Other ocular diseases or conditions that may affect the recovery of the macula functions based on the opinion of investigators, such as foveal atrophy, foveal hemorrhage, foveal hard exudates, or dense submacular hard exudates, etc.;
- History of retinal detachment;
- Suffering from non-RVO diseases that may result in macular edema, visual acuity loss or retinal neovascularization during the study period based on the opinion of investigators, such as wet AMD, diabetic retinopathy, uveitis or other ocular inflammatory diseases, neovascular glaucoma, and cystoid macular edema, etc.;
- Patients with cataract whose eye is likely to require cataract surgery within the next 12 months;
- Have received intraocular injection of corticosteroid within previous 3 months, received subconjunctiva injection of corticosteroid within previous 6 months, or received ocular corticosteroid therapy within previous 1 month;
- Have undergone any of the following ocular surgeries: scleral buckling surgery, PDT, vitrectomy, radial optic neurotomy or sheathotomy, glaucoma filtration surgery, parafoveal photocoagulation, pan-retinal photocoagulation, and macular translocation surgery, etc.;
- Have received YAG laser surgery or any other ocular surgery (which including cataract surgery, macular grid photocoagulation, local retinal photocoagulation, and corneal implantation, etc.) within previous 3 months;
- Improvement of BCVA\>10 letters during screening period (comparing BCVA that is measured within 24h before first administration (Day 0) to that measured at enrollment);
- Without lens (excluding intraocular lens) or with posterior lens capsule defect (excluding YAG laser capsulotomy following intraocular lens implantation);
- \- Either eye of patients：
- Suffering from active periophthalmitis or ocular inflammation (such as blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis and endophthalmitis, etc.);
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
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 General Hospital of the People's Liberation Army
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
Guangzhou, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, China
The Jiangxi Provincial People's Hospital
Nanchang, 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
Zhongshan Hospital
Shanghai, China
The First Hospital of China Medical University
Shenyang, China
Tianjin Eye Hospital
Tianjin, China
Tianjin Medical University Eye Hospital School of Optometry & Eye Institute
Tianjin, 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
The First Affiliated Hospital of Xi'An Jiaotong University
Xi'an, China
MeSH Terms
Conditions
Interventions
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
July 21, 2017
Study Start
May 24, 2016
Primary Completion
April 13, 2020
Study Completion
September 28, 2020
Last Updated
July 13, 2022
Record last verified: 2022-07