Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion

Retinal Vein Occlusion Clinical Trial

Official title:

Different Regimens of Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion: a Randomized and Controlled Clinical Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04062370
• Other study ID #: 2019KYPJ092
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 1, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2019
• Source: Sun Yat-sen University
• Contact: Yanjie Yan
• Phone: +8620-87332529
• Email: zocethics[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Macular Edema
• Photocoagulation Burn to Retina
• Ranibizumab
• Retinal Vein Occlusion
• Treatment

Intervention

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.

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.

Locations

Country	Name	City	State
China	Chuangxin Huang	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	best-corrected visual acuity (BCVA) during the follow-up	best-corrected visual acuity (BCVA) during the follow-up	during the follow-up for up to 12 months.
Other	intraocular pressure during the follow-up	intraocular pressure during the follow-up	during the follow-up for up to 12 months.
Other	central macular thickness during the follow-up	central macular thickness during the follow-up	during the follow-up for up to 12 months.
Other	posterior choroidal thickness during the follow-up	posterior choroidal thickness during the follow-up	during the follow-up for up to 12 months.
Other	The results of angio-optical coherence tomography (angio-OCT) examination during the follow-up	The results of angio-OCT examination, including area of non-perfusion and neovascularization.	during the follow-up for up to 12 months.
Other	Fundus fluorescein angiography (FFA) examination results during the follow-up	FFA examination results during the follow-up, including area of non-perfusion and neovascularization.	during the follow-up for up to 12 months.
Other	Microperimetry during the follow-up	Changes in posterior pole found by microperimetry	during the follow-up for up to 12 months.
Other	Electroretinogram (ERG) during the follow-up	Amplitudes and implicit times of the a wave and b wave of ERG during the follow-up	during the follow-up for up to 12 months.
Other	adverse events occurring in the follow-up	Records of adverse events occurring in the follow-up period: including subconjunctival hemorrhage, infection, increased intraocular pressure, retinal tear, retinal detachment, etc.	during the follow-up for up to 12 months.
Primary	best-corrected visual acuity (BCVA) at month 6	best-corrected visual acuity (BCVA) at month 6	Month 6 after first treatment
Primary	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	Month 6 after first treatment
Primary	the number of intravitreal injections of Ranibizumab at month 6	the number of intravitreal injections of Ranibizumab at month 6	Month 6 after first treatment
Secondary	best-corrected visual acuity (BCVA) at month 12	best-corrected visual acuity (BCVA) at month 12	Month 12 after first treatment
Secondary	the number of intravitreal injections of Ranibizumab at month 12	the number of intravitreal injections of Ranibizumab at month 12	Month 12 after first treatment