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Branch Retinal Vein OcclusionPhase 3BRAVENCT03108352

Conbercept Ophthalmic Injection for Patients With Macular Edema Caused by Branch Retinal Vein Occlusion

A Phase 3 study testing Conbercept ophthalmic injection in people with Branch Retinal Vein Occlusion and Macular Edema, run by Chengdu Kanghong Biotech Co., Ltd. at 31 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Branch Retinal Vein Occlusion, Macular Edema
What is being tested?
Conbercept ophthalmic injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
255 participants
Where
31 sitesChina
Study dates
13 Apr 2016to 16 Oct 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Note: The eye of interest is determined by the researcher from a medical point of view if both eyes of the patient meet the inclusion criteria. In principle, the eye with poor eyesight or thicker central retina should be selected as the eye of interest.

Who cannot join

  • 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;
Show all 38Show fewer
  • 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);
  • Has previous or existing uncontrollable glaucoma (defined as IOP remaining at ≥ 30 mmHg after anti-glaucoma treatment), or has a cup-to-disc ratio of the eye of interest of above 0.8 due to severe glaucoma;
  • Has received intravitreal injection of any anti-VEGF agents (e.g.,ranibizumab, bevacizumab, and conbercept) within three months before screening;
  • Patient with any of the following systemic diseases:
  • Has a history of anaphylaxis and allergy to fluorescein sodium, and of allergy to protein products for diagnosis or treatment, and is allergic to no less than two drugs and/or non-drug factors, or suffers from allergic diseases now;
  • Has a history of stroke, has a history of myocardial and/or cerebral infarction(s) and of transient cerebral ischemia within 6 months before screening, and has active and disseminated intravascular coagulation and distinct bleeding tendency;
  • Has confirmed systemic immune disease (e.g., ankylosing spondylitis, systemic lupus erythematosus, and Behcet's disease, rheumatoid arthritis, and scleroderma);
  • Has any uncontrollable clinical problem (e.g., AIDS, active hepatitis, severe mental, neurological, cardiovascular and respiratory diseases, and malignancies);
  • Hyperpietics with poor blood pressure control (defined as SBP remaining at ≥ 160 mmHg or DBP remaining ≥ 100 mmHg after antihypertensives therapy);
  • Has a surgical history within one month before screening, and/or has unhealed wounds, ulcers and fractures at present;
  • Has systemically used corticosteroids (orally, intramuscularly, intravenously) within 6 months before screening;
  • Has received systemic treatment with anti-VEGF agent(s) (e.g., bevacizumab) within 6 months before screening; Patients with any of the following abnormal laboratory tests
  • Those who have hepatic, renal and immunologic dysfunction (this trial specifies that ALT and AST are twice as high as the ULN of this central laboratory, and that Crea and BUN are 1.5-fold as high as the ULN of this central laboratory);
  • Those who have coagulation abnormalities (PT is 3 seconds greater than or equal to the ULN, and APTT is 10 seconds greater than or equal to the ULN); Patients of childbearing age with any of the following condition
  • Those who do not take effective contraceptive measures at childbearing age; Note: The following conditions are not included in the exclusion range.
  • Amenorrhea for 12 months under the natural condition, or amenorrhea for 6 months under the natural condition and the serum FSH level of < 40 mIU/ml;
  • Six weeks after bilateral ovariectomy with/without hysterectomy;
  • Use of the following one or more acceptable contraceptions:
  • Sterilization (for males, with bilateral vasoligation and vasectomy)
  • Hormonal contraception (implantable, patchable, oral)
  • Intrauterine device and dural barrier method
  • Ability to take reliable contraceptive measures over the study period and hold on to 30 days after study drug withdrawal (unacceptable contraceptive methods include: periodic continence - according to the calendar and ovulatory phase, body thermometry, post-ovulatory method, and coitus interruptus);
  • Pregnant women and breastfeeding mothers (in this trial pregnancy is defined as positive U-HCG); Others
  • Patient has participated in any drug (not including vitamins and minerals) clinical trial three months before screening (if the study drug has a long half-life, i.e., its five half-lives exceed three months, then it is deemed as five half-lives); Any condition in which the researcher deems necessary to be excluded in the study.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites

  • The General Hospital of the People's Liberation Army

    Beijing, Beijing Municipality

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

  • Beijing Tongren Hospital, Capital Medical University

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Peking University First Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • Peking University Third Hospital

    Beijing

  • The Second Hospital of Jilin University

    Changchun

  • The Second Xiangya Hospital of Central South University

    Changsha

  • West China Hospital Sichuan University

    Chengdu

  • Army Medical Center

    Chongqing

  • The Second Hospital of Dalian Medical University

    Dalian

  • Zhongshan Ophthalmic Center, Sun Yat-Sen University

    Guangzhou

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin

  • The Jiangxi Provincial People's Hospital

    Nanchang

  • Jiangsu Province Hospital

    Nanjing

  • Nanjing First Hospital

    Nanjing

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning

  • Eye & Ent Hospital of Fudan University

    Shanghai

  • Shanghai General Hospital

    Shanghai

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai

  • Zhongshan Hospital

    Shanghai

  • The First Hospital of China Medical University

    Shenyang

  • Tianjin Medical University Eye Hospital School of Optometry & Eye Institute

    Tianjin

  • Tianjin Eye Hospital

    Tianjing

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi

  • Eye Hospital,WMU Zhejiang Eye Hospital

    Wenzhou

  • Wuhan General Hospital of Guangzhou Military Command

    Wuhan

  • Wuxi No.2 People's Hospital

    Wuxi

  • The First Affiliated Hospital of Xi'An

    Xi'an

Other trials in China

About this study

Official title: Multi-center, Randomized, Double-masked, Placebo-controlled Phase III Clinical Study of Conbercept Ophthalmic Injection for Patients With BRVO.

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).

Being tested
Conbercept ophthalmic injection, sham/Conbercept ophthalmic injection
Medical subject headings
Retinal Vein Occlusion, Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conbercept ophthalmic injectionDrug

    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/Conbercept ophthalmic injectionOther

    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)

Study groups in NCT03108352
Study groupRoleWhat they receive
Conbercept ophthalmic injectionExperimentalConbercept ophthalmic injection
Receives: Drug: Conbercept ophthalmic injection
Sham ComparatorSham comparatorsham / Conbercept ophthalmic injection
Receives: Drug: Conbercept ophthalmic injection; Other: sham/Conbercept ophthalmic injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: month 6

Secondary outcomes (7)

  1. Best Corrected Visual Acuity (BCVA)

    1>o evaluate mean changes in BCVA from baseline of the treatment group and the control group at month 3 and 12.

    Measured: month 3 and month 12

  2. Central Retinal Thickness

    To evaluate mean changes in Central Retinal Thickness (CRT) from baseline of the treatment group and the control group at month 3, 6 and 12.

    Measured: month 3, month 6 and month 12

  3. resue treament

    To evaluate the number of subjects who received laser rescue treatment of the treatment group and the control group at month 6 and 12.

    Measured: month 6 and month 12

  4. Number of participants with treatment-related the systemic and ocular safely as assessed

    To evaluate the systemic and ocular safety of the treatment group and the control group.

    Measured: up to 12.5 months

  5. distribution of BCVA changes

    To evaluate the distribution of BCVA changes from baseline of the treatment group and the control group at month 3, 6 and 12.

    Measured: month 3, month 6 and month 12

  6. mean changes in BCVA

    To evaluate mean changes in BCVA from baseline of the treatment group and the control group at every visit.

    Measured: 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

  7. Change in image

    To evaluate the average changes in imaging findings (e.g., CRT and total macular volume) relative to the baseline for treatment group and control group at each follow-up visit.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2017
  2. Study start13 Apr 2016
  3. Primary completion13 Apr 2020
  4. Study completion16 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03108352
Sponsor's protocol ID
KH902-BRVO-CRP-1.0
Acronym
BRAVE
Status last verified
Jul 2022
First submitted
8 Feb 2017
Last updated
15 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wei W, Shi X, Li X, Li X, Han Q, Zhang Q, Sun X, Ye J, Chen Y, Liu XL, Wang P, Zhang M, Su G, Wang L, Wang Y, Zhang Y, Liu Q, Zhang Q, Huang M, Tang L, Yuan F, Dou H, Song Y, Lu L, Wang S, Qin L, Yang L, Liu T, Yao K, Liu ZL, Chen X, Shao Y, Ke Z, Ke X, Niu Z, Xinguo W, Han X, Zhang Z, Diao T, Zheng Q. Efficacy and safety of intravitreal conbercept injection in treating macular oedema secondary to branch retinal vein occlusion: results from the BRAVE study. Br J Ophthalmol. 2026 Sep 23:bjo-2024-326355. doi: 10.1136/bjo-2024-326355. Online ahead of print.

    PubMed 42778337

  • 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.

    PubMed 32633861

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Conbercept ophthalmic injection in people with Branch Retinal Vein Occlusion and Macular Edema, run by Chengdu Kanghong Biotech Co., Ltd. at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Corrected Visual Acuity (time frame: month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03108352, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.

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