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Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion

Primary Purpose

Retinal Vein Occlusion, Treatment, Photocoagulation Burn to Retina

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ranibizumab
laser photocoagulation
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Chuangxin Huang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1+PRN

3+PRN

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

best-corrected visual acuity (BCVA) at month 6
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
Central macular thickness (CMT) at month 6
the number of intravitreal injections of Ranibizumab at month 6
the number of intravitreal injections of Ranibizumab at month 6

Secondary Outcome Measures

best-corrected visual acuity (BCVA) at month 12
best-corrected visual acuity (BCVA) at month 12
the number of intravitreal injections of Ranibizumab at month 12
the number of intravitreal injections of Ranibizumab at month 12

Full Information

First Posted
July 29, 2019
Last Updated
August 18, 2019
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04062370
Brief Title
Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion
Official Title
Different Regimens of Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion: a Randomized and Controlled Clinical Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion, Treatment, Photocoagulation Burn to Retina, Ranibizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1+PRN
Arm Type
Experimental
Arm Description
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.
Arm Title
3+PRN
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
laser photocoagulation
Intervention Description
After month 6, patients will received Ranibizumab PRN only or laser photocoagulation with Ranibizumab PRN according the re-randomization at month 6.
Primary Outcome Measure Information:
Title
best-corrected visual acuity (BCVA) at month 6
Description
best-corrected visual acuity (BCVA) at month 6
Time Frame
Month 6 after first treatment
Title
Central macular thickness (CMT) at month 6 (3) the number of intravitreal injections of Ranibizumab at month 6
Description
Central macular thickness (CMT) at month 6
Time Frame
Month 6 after first treatment
Title
the number of intravitreal injections of Ranibizumab at month 6
Description
the number of intravitreal injections of Ranibizumab at month 6
Time Frame
Month 6 after first treatment
Secondary Outcome Measure Information:
Title
best-corrected visual acuity (BCVA) at month 12
Description
best-corrected visual acuity (BCVA) at month 12
Time Frame
Month 12 after first treatment
Title
the number of intravitreal injections of Ranibizumab at month 12
Description
the number of intravitreal injections of Ranibizumab at month 12
Time Frame
Month 12 after first treatment
Other Pre-specified Outcome Measures:
Title
best-corrected visual acuity (BCVA) during the follow-up
Description
best-corrected visual acuity (BCVA) during the follow-up
Time Frame
during the follow-up for up to 12 months.
Title
intraocular pressure during the follow-up
Description
intraocular pressure during the follow-up
Time Frame
during the follow-up for up to 12 months.
Title
central macular thickness during the follow-up
Description
central macular thickness during the follow-up
Time Frame
during the follow-up for up to 12 months.
Title
posterior choroidal thickness during the follow-up
Description
posterior choroidal thickness during the follow-up
Time Frame
during the follow-up for up to 12 months.
Title
The results of angio-optical coherence tomography (angio-OCT) examination during the follow-up
Description
The results of angio-OCT examination, including area of non-perfusion and neovascularization.
Time Frame
during the follow-up for up to 12 months.
Title
Fundus fluorescein angiography (FFA) examination results during the follow-up
Description
FFA examination results during the follow-up, including area of non-perfusion and neovascularization.
Time Frame
during the follow-up for up to 12 months.
Title
Microperimetry during the follow-up
Description
Changes in posterior pole found by microperimetry
Time Frame
during the follow-up for up to 12 months.
Title
Electroretinogram (ERG) during the follow-up
Description
Amplitudes and implicit times of the a wave and b wave of ERG during the follow-up
Time Frame
during the follow-up for up to 12 months.
Title
adverse events occurring in the follow-up
Description
Records of adverse events occurring in the follow-up period: including subconjunctival hemorrhage, infection, increased intraocular pressure, retinal tear, retinal detachment, etc.
Time Frame
during the follow-up for up to 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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); 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; 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: Patients with a course of disease > 12 weeks; 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; Patients with their study eyes treated with panretinal photocoagulation (PRP) previously; Patients previously participating in other clinical trials 3 months before the baseline; Patients with severely opacity of refractive media affecting laser treatment and observation; Patients with other ophthalmic diseases affecting visual prognosis, such as corneal disease, glaucoma, severe cataract, uveitis, other fundus diseases, etc. Patients with in any condition where intravitreal injection is unacceptable; 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. Patients with any history may interfere with the results of the trial or increase the risk of the patient (assessed by the investigator) ; Patients who are in poor compliance and unable to strictly implement the protocol (assessed by the investigator).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanjie Yan
Phone
+8620-87332529
Email
zocethics@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chenjin Jin, Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chuangxin Huang
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuangxin Huang
Phone
+862087331366
Email
sumshuang@163.com
First Name & Middle Initial & Last Name & Degree
Chenjin Jin
Phone
13302209900
First Name & Middle Initial & Last Name & Degree
Chenjin Jin, ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
25972260
Citation
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.
Results Reference
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Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion

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