Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03223714
Other study ID # KH902-CRVO-CRP-1.0
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 24, 2016
Est. completion date September 28, 2020

Study information

Verified date July 2022
Source Chengdu Kanghong Biotech Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 ophthalmic injection treatment group or the control group at a ratio of 2:1.


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.


Recruitment information / eligibility

Status Completed
Enrollment 242
Est. completion date September 28, 2020
Est. primary completion date April 13, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients have signed informed consent and agreed to be followed up as per the trial protocol; 2. Aged = 18 years, male or female; 3. 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; 4. 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. Exclusion Criteria: Patients who present with any the following ocular conditions: - Study eyes 1. Active retinal or iris neovascularization; 2. Epiretinal membrane or vitreomacular traction that investigators consider likely to affect central vision; 3. 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.; 4. History of retinal detachment; 5. 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.; 6. Patients with cataract whose eye is likely to require cataract surgery within the next 12 months; 7. 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; 8. 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.; 9. 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; 10. 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); 11. Without lens (excluding intraocular lens) or with posterior lens capsule defect (excluding YAG laser capsulotomy following intraocular lens implantation); - Either eye of patients: 12. Suffering from active periophthalmitis or ocular inflammation (such as blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis and endophthalmitis, etc.); 13. 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; 14. 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: 15. 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; 16. 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; 17. Patients who are diagnosed with systemic autoimmune diseases (such as ankylosing spondylitis, systemic lupus erythematosus, Behcet's disease, rheumatoid arthritis, and scleroderma, etc.); 18. 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); 19. Hypertensive patients whose blood pressure have not been controlled effectively (defined as SBP =160 mmHg or DBP =100 mmHg after treatment with antihypertensive drugs); 20. Patient who has a surgical history within 1 month before enrollment, and/or is currently suffering from unhealed wounds, ulcers, fractures, etc.; 21. Use of systemic (orally, intramuscularly or intravenously) corticosteroids within 6 months before screening; 22. 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 23. 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); 24. 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: 25. 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); 26. Pregnant and breast-feeding women. Pregnancy is defined as a positive urine pregnancy test in this trial; Others 27. 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); 28. The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.

Study Design


Intervention

Drug:
Conbercept Ophthalmic Injection
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 injection
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).

Locations

Country Name City State
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 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 Urumqi
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

Sponsors (1)

Lead Sponsor Collaborator
Chengdu Kanghong Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other 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. month 3, month 6 and month 12
Other Mean change in Best Corrected Visual Acuity To evaluate mean changes in BCVA from baseline of the treatment group and the control group at every visit for 1 year. 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
Other Mean changes in CRT, Macular Volume 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 for 1 year 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
Primary 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 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. month 3 and month 12
Secondary 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. month 3, month6 and month 12
Secondary 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. month 6 and month 12
Secondary 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. month 6 and month 12 or trail period
See also
  Status Clinical Trial Phase
Completed NCT04292912 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema Phase 1
Recruiting NCT05976139 - Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies N/A
Completed NCT03660371 - ILM Peeling in PDR Patients Undergoing PPV for VH N/A
Completed NCT03660345 - PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME Phase 3
Completed NCT01660802 - Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO) Phase 3
Completed NCT01908816 - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. Phase 3
Completed NCT04592419 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO) Phase 3
Completed NCT02867735 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema Phase 1
Completed NCT02623673 - Simultaneous Therapy With Intravitreal Dexamethasone Implant and Bevacizumab for the Treatment of Macular Edema N/A
Terminated NCT01946399 - Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF N/A
Completed NCT01428388 - Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion N/A
Completed NCT01231633 - Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO) N/A
Recruiting NCT01023113 - To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation N/A
Terminated NCT00969293 - Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion Phase 1
Terminated NCT00918554 - Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis Phase 4
Completed NCT00970957 - Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion Phase 3
Completed NCT00476593 - Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications N/A
Completed NCT00668239 - Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser N/A
Completed NCT00411970 - 20- Versus 23- Gauge System for Pars Plana Vitrectomy Phase 4
Terminated NCT01939691 - Macular Edema Nepafenac vs. Difluprednate Uveitis Trial Phase 4