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Macular EdemaPhase 3CRAVENCT03223714

Conbercept Ophthalmic Injection for Patients of Central Retinal Vein Occlusion

A Phase 3 study testing Conbercept Ophthalmic Injection in people with Macular Edema and Central Retinal Vein Occlusion, run by Chengdu Kanghong Biotech Co., Ltd. at 27 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

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Macular Edema, Central Retinal Vein Occlusion
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
242 participants
Where
27 sitesChina
Study dates
24 May 2016to 28 Sep 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 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.
  • Note: If both eyes of a subject meet the inclusion criteria, the target eye shall be determined by investigators from a medical point of view.

Who cannot join

  • 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;
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  • 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.);
  • Had or have uncontrollable glaucoma (defined as intraocular pressure remains ≥30 mmHg after anti-glaucoma treatment), or study eye with the cup-to-disc ratio > 0.8 due to severe glaucoma;
  • Have received anti-VEGF medications (such as Lucentis, Avastin, or Conbercept, etc.) within 3 months before screening;
  • Patients who present with any the following systematic conditions:
  • Patients have allergic reaction or history of allergy to sodium fluorescein, have a history of allergy to protein products for therapy or diagnosis, and are sensitized to two or more drugs and/or non-drug factors, or suffering from allergic diseases;
  • Patients with a history of stroke, or with a history of myocardial infarction and/or cerebrovascular disease or a history of transient cerebral ischemia within 6 months before screening, or with active disseminated intravascular coagulation and significant bleeding tendencies;
  • Patients who are diagnosed with systemic autoimmune diseases (such as ankylosing spondylitis, systemic lupus erythematosus, Behcet's disease, rheumatoid arthritis, and scleroderma, etc.)；
  • Patients who are diagnosed with any clinically uncontrollable disease (such as HIV, active hepatitis, metabolic disorders, severe mental, neurological, cardiovascular, respiratory and other diseases and cancer);
  • Hypertensive patients whose blood pressure have not been controlled effectively (defined as SBP ≥160 mmHg or DBP ≥100 mmHg after treatment with antihypertensive drugs);
  • Patient who has a surgical history within 1 month before enrollment, and/or is currently suffering from unhealed wounds, ulcers, fractures, etc.;
  • Use of systemic (orally, intramuscularly or intravenously) corticosteroids within 6 months before screening;
  • Patients received systemic anti-VEGF medications (such as Avastin) within 6 months before screening; Patients underwent laboratory test with any of the following abnormal results
  • Liver, kidney and immune dysfunction (defined as ALT and AST ≥ 2 × UNL of the laboratory , Crea and BUN ≥ 1.5 × UNL of the laboratory in the site of this trial);
  • Coagulation abnormalities (prothrombin time ≥ 3 seconds + UNL, and active partly thromboplastin time ≥ 10 seconds + UNL);
  • Patients of childbearing age under any of the following conditions:
  • Do not use an effective method of contraception;
  • Note: subject with the following conditions are not excluded:
  • 12 months of amenorrhea for natural reasons, or 6 months of natural amenorrhea for natural reasons and levels of serum follicle stimulating hormone <40mlU/ml;
  • 6 weeks after ovariectomy of both sides with / without concurrent hysterectomy;
  • Use one or more acceptable birth control methods as follows:
  • Sterilization (male companion has undergone bilateral vasectomy or resection) Hormonal birth control (implantable, patch or oral route) Intrauterine device and double barrier methods
  • Take reliable birth control measures throughout the study period, and continuously do so for 30 d after stopping study medication (unacceptable birth control methods including periodic abstinence, calendar-based method, ovulation phase method, body temperature measurement, luteal phase method and onanism);
  • Pregnant and breast-feeding women. Pregnancy is defined as a positive urine pregnancy test in this trial; Others
  • Participate in any drug (exclusive of vitamins and minerals) clinical trial within 3 months prior to the screening (if the investigational drug has a long half-life, 3 months or 5 half-lives, whichever is longer);
  • The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

China27 sites

  • 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 General Hospital of the People's Liberation Army

    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

    Guangzhou

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin

  • The Jiangxi Provincial People's Hospital

    Nanchang

  • Nanjing First Hospital

    Nanjing

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning

  • Eye & Ent Hospital of Fudan University

    Shanghai

  • Shanghai General Hospital

    Shanghai

  • Zhongshan Hospital

    Shanghai

  • The First Hospital of China Medical University

    Shenyang

  • Tianjin Eye Hospital

    Tianjin

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

    Tianjin

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi

  • Eye Hospital,WMU Zhejiang Eye Hospital

    Wenzhou

  • Wuhan General Hospital of Guangzhou Military Command

    Wuhan

  • The First Affiliated Hospital of Xi'An Jiaotong University

    Xi'an

Other trials in China

About this study

Official title: An Efficacy and Safety Trial of Intravitreal Injection of Conbercept Ophthalmic Injection in Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion

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.

Read the detailed description

The trial is divided into core and extension periods.

  1. Core period (Day 0 - Month 5): Eligible subjects after the screening are assigned into the group to receive either intravitreal injection of Conbercept ophthalmic injection at a dose of 0.5 mg (treatment group) or a sham injection (control group) into their study eyes every month (Day 0 - Month 5). At month 6, primary endpoint are judged by investigators.
  2. Extension period (Month 6 ~ 12): Subjects in treatment group are reviewed monthly, if he/she meets the criteria for repeated administration, the subject receives 0.5 mg Conbercept injection into the study eye (Month 6 ~ 11). Subjects in control group 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). The final evaluation is performed at the end of Month 12.
Being tested
Conbercept Ophthalmic Injection, sham injection
Keywords
Conbercept ophthalmic injection, ME, CRVO
Medical subject headings
Macular Edema, Retinal Vein Occlusion

What participants receive

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

  • Conbercept Ophthalmic InjectionDrug

    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).

  • sham injectionDrug

    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).

Study groups in NCT03223714
Study groupRoleWhat they receive
ConberceptExperimentalConbercept
Receives: Drug: Conbercept Ophthalmic Injection
Conbercept or shamSham comparatorConbercept or sham
Receives: Drug: Conbercept Ophthalmic Injection; Drug: sham injection

What is being measured

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

  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.

    Measured: month 6

Secondary outcomes (4)

  1. Best Corrected Visual Acuity

    To 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, month6 and month 12

  3. Number of subject who received laser rescue treatment

    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: month 6 and month 12 or trail period

Timeline

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

  1. First posted21 Jul 2017
  2. Study start24 May 2016
  3. Primary completion13 Apr 2020
  4. Study completion28 Sep 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
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03223714
Sponsor's protocol ID
KH902-CRVO-CRP-1.0
Acronym
CRAVE
Status last verified
Jul 2022
First submitted
8 Feb 2017
Last updated
13 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Conbercept Ophthalmic Injection in people with Macular Edema and Central Retinal Vein Occlusion, run by Chengdu Kanghong Biotech Co., Ltd. at 27 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 39 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 13 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 27 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 NCT03223714.

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 13 Jul 2022.

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