NCT04062370

Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-01
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2019-08-20
• Last updated: 2019-08-20

Locations

1 site across 1 country: China