Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04062370
Recruitment Status : Not yet recruiting
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Jin Chen-jin, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE July 29, 2019
First Posted Date  ICMJE August 20, 2019
Last Update Posted Date August 20, 2019
Estimated Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2019)
  • best-corrected visual acuity (BCVA) at month 6 [ Time Frame: Month 6 after first treatment ]
    best-corrected visual acuity (BCVA) at month 6
  • Central macular thickness (CMT) at month 6 (3) the number of intravitreal injections of Ranibizumab at month 6 [ Time Frame: Month 6 after first treatment ]
    Central macular thickness (CMT) at month 6
  • the number of intravitreal injections of Ranibizumab at month 6 [ Time Frame: Month 6 after first treatment ]
    the number of intravitreal injections of Ranibizumab at month 6
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2019)
  • best-corrected visual acuity (BCVA) at month 12 [ Time Frame: Month 12 after first treatment ]
    best-corrected visual acuity (BCVA) at month 12
  • the number of intravitreal injections of Ranibizumab at month 12 [ Time Frame: Month 12 after first treatment ]
    the number of intravitreal injections of Ranibizumab at month 12
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 18, 2019)
  • best-corrected visual acuity (BCVA) during the follow-up [ Time Frame: during the follow-up for up to 12 months. ]
    best-corrected visual acuity (BCVA) during the follow-up
  • intraocular pressure during the follow-up [ Time Frame: during the follow-up for up to 12 months. ]
    intraocular pressure during the follow-up
  • central macular thickness during the follow-up [ Time Frame: during the follow-up for up to 12 months. ]
    central macular thickness during the follow-up
  • posterior choroidal thickness during the follow-up [ Time Frame: during the follow-up for up to 12 months. ]
    posterior choroidal thickness during the follow-up
  • The results of angio-optical coherence tomography (angio-OCT) examination during the follow-up [ Time Frame: during the follow-up for up to 12 months. ]
    The results of angio-OCT examination, including area of non-perfusion and neovascularization.
  • Fundus fluorescein angiography (FFA) examination results during the follow-up [ Time Frame: during the follow-up for up to 12 months. ]
    FFA examination results during the follow-up, including area of non-perfusion and neovascularization.
  • Microperimetry during the follow-up [ Time Frame: during the follow-up for up to 12 months. ]
    Changes in posterior pole found by microperimetry
  • Electroretinogram (ERG) during the follow-up [ Time Frame: during the follow-up for up to 12 months. ]
    Amplitudes and implicit times of the a wave and b wave of ERG during the follow-up
  • adverse events occurring in the follow-up [ Time Frame: during the follow-up for up to 12 months. ]
    Records of adverse events occurring in the follow-up period: including subconjunctival hemorrhage, infection, increased intraocular pressure, retinal tear, retinal detachment, etc.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion
Official Title  ICMJE Different Regimens of Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion: a Randomized and Controlled Clinical Study.
Brief Summary Retinal vein occlusion (RVO) may lead to series of complications including retinal ischemia, macular edema (ME) and induce vision impairment. Intravitreal injection of Ranibizumab (0.5mg) has been proved to be a safe and effective method for the treatment of RVO-ME. In this study, different treatment regimens of Ranibizumab is applied and the effects is observed at 1-6 months to explore the best regimen for RVO. After 6 months, anti-VEGF therapy and/or laser photocoagulation is used to explore whether laser photocoagulation can maintain the therapeutic effect of Ranibizumab or reduce the injection number.
Detailed Description Retinal vein occlusion (RVO) may lead to series of complications including retinal ischemia, macular edema (ME) and so on. Retinal vein occlusion (RVO) can be classified as branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). Retinal vein occlusion with macular edema (RVO-ME) is the main cause of RVO induced vision impairment. Intravitreal injection of Ranibizumab (0.5mg) has been proved to be a safe and effective method for the treatment of RVO-ME. Although multiple injections of anti-vascular endothelial growth factor (anti-VEGF) drugs are beneficial to the therapeutic results of RVO-ME, they may also increase the risk of systemic or ocular complications and at the same time increase the economic burden of patients to a certain extent. Different studies have shown that anti-VEGF therapy with low frequency injection (2-5 doses) is also effective for RVO-related ME. However, there are still different views on which option is better. Meanwhile, the effect of laser photocoagulation in the non-perfusion area of the retina, and whether the number of subsequent anti-VEGF injections can be reduced accordingly, is still uncertain. Therefore, in this study, different treatment regimens will be applied and the effects will be observed at 1-6 months. After 6 months, anti-VEGF therapy and/or laser photocoagulation will be used to explore whether laser photocoagulation can maintain the therapeutic effect or reduce the injection number of Ranibizumab. This study intends to explore the therapeutic effects of different treatment regimens on RVO-ME, and meanwhile to investigate the dynamic changes in retinal morphology, microcirculation and visual function during RVO treatment by means of angiography-optical coherence tomography (angio-OCT), microperimetry, electroretinogram (ERG) examination and other methods.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a prospective, randomized, controlled, parallel, open-label, exploratory clinical trial. Including 100 patients, 50 : 50 in each arm. Different frequency of Ranibizumab is applied in this study.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Retinal Vein Occlusion
  • Treatment
  • Photocoagulation Burn to Retina
  • Ranibizumab
Intervention  ICMJE
  • Drug: Ranibizumab
    Patients will receive intravitreal injection of Ranibizumab 0.5 mg (1+PRN or 3+PRN) according to the study until month 6. Then, patients will received Ranibizumab PRN only or laser photocoagulation with Ranibizumab PRN after month 6.
    Other Name: Lucentis
  • Device: laser photocoagulation
    After month 6, patients will received Ranibizumab PRN only or laser photocoagulation with Ranibizumab PRN according the re-randomization at month 6.
Study Arms  ICMJE
  • Experimental: 1+PRN

    Intravitreal injection of Ranibizumab 0.5 mg (IVR): initial injection for 1 time ( month 1), and then IVR is required if central macular thickness (CMT) greater than 300 μm during the follow-up observation (Pro re nata, PRN, means if necessary).

    After 6 months follow-up, patients in this arm will be randomly divided to receive IVR PRN only or laser photocoagulation combined with IVR PRN.

    IVR PRN only: patient will receive IVR PRN if CMT greater than 300 μm during the follow-up observation (PRN) after month 6.

    Laser photocoagulation with IVR PRN: patient will receive laser photocoagulation for non-perfusion area according to FFA results after month 6, and then received IVR PRN if CMT greater than 300 μm.

    Interventions:
    • Drug: Ranibizumab
    • Device: laser photocoagulation
  • Active Comparator: 3+PRN

    Intravitreal injection of Ranibizumab 0.5 mg (IVR): initial injection for 3 consecutive times ( months 1, 2 and 3 ),and then IVR is required if CMT greater than 300 μm during the follow-up observation (PRN).

    After 6 months follow-up, patients in this arm will be randomly divided to receive IVR PRN only or laser photocoagulation combined with IVR PRN.

    IVR PRN only: patient will receive IVR PRN if CMT greater than 300 μm during the follow-up observation (PRN) after month 6.

    Laser photocoagulation with IVR PRN: patient will receive laser photocoagulation for non-perfusion area according to FFA results after month 6, and then received IVR PRN if CMT greater than 300 μm.

    Interventions:
    • Drug: Ranibizumab
    • Device: laser photocoagulation
Publications * Campochiaro PA, Hafiz G, Mir TA, Scott AW, Solomon S, Zimmer-Galler I, Sodhi A, Duh E, Ying H, Wenick A, Shah SM, Do DV, Nguyen QD, Kherani S, Sophie R. Scatter Photocoagulation Does Not Reduce Macular Edema or Treatment Burden in Patients with Retinal Vein Occlusion: The RELATE Trial. Ophthalmology. 2015 Jul;122(7):1426-37. doi: 10.1016/j.ophtha.2015.04.006. Epub 2015 May 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 18, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2022
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with RVO-ME diagnosed definitely by FFA and OCT, with CMT > 300μm; BCVA from 20/200 to 20/40 (including 20/200 and 20/40), with a degree of myopia ≤-6 diopter (diopter, D);
  2. Patients with a course of RVO ≤ 12 weeks; Patients who have not received laser, intraocular or systemic anti-VEGF treatments or long-acting hormone intraocular, periocular or systemic treatments since the onset of RVO;
  3. Patients who are voluntary to sign and date the informed consent form approved by the Ethics Review Committee prior to the conduct of the relevant study steps.

Exclusion Criteria:

  1. Patients with a course of disease > 12 weeks;
  2. Patients treated with any anti-angiogenic medicines for either eye within 3 months before the baseline; or patients currently in treatment with systemic anti-angiogenic drugs;
  3. Patients with their study eyes treated with panretinal photocoagulation (PRP) previously;
  4. Patients previously participating in other clinical trials 3 months before the baseline;
  5. Patients with severely opacity of refractive media affecting laser treatment and observation;
  6. Patients with other ophthalmic diseases affecting visual prognosis, such as corneal disease, glaucoma, severe cataract, uveitis, other fundus diseases, etc.
  7. Patients with in any condition where intravitreal injection is unacceptable;
  8. Patients identified by the investigator to be medically or mentally unstable: complicated with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases or mental disease; Women who are pregnant or preparing for pregnancy or in lactation, etc.
  9. Patients with any history may interfere with the results of the trial or increase the risk of the patient (assessed by the investigator) ;
  10. Patients who are in poor compliance and unable to strictly implement the protocol (assessed by the investigator).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yanjie Yan +8620-87332529 zocethics@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04062370
Other Study ID Numbers  ICMJE 2019KYPJ092
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin Chen-jin, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chenjin Jin, Ph.D Zhongshan Ophthalmic Center, Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP