A Phase 4 interventional study of Ranibizumab and laser photocoagulation in Retinal Vein Occlusion, Treatment and Photocoagulation Burn to Retina, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by Sun Yat-sen University · Phase 4, Interventional, and Treatment
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.
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.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 619 interventional studies indexed under Macular Edema.
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Exclusion Criteria:
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.
Drug: Ranibizumab · Device: laser photocoagulation
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.
Drug: Ranibizumab · Device: laser photocoagulation
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.
Also known as: Lucentis
After month 6, patients will received Ranibizumab PRN only or laser photocoagulation with Ranibizumab PRN according the re-randomization at month 6.
best-corrected visual acuity (BCVA) at month 6
best-corrected visual acuity (BCVA) at month 6
Time frame: Month 6 after first treatment
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
Time frame: Month 6 after first treatment
the number of intravitreal injections of Ranibizumab at month 6
the number of intravitreal injections of Ranibizumab at month 6
Time frame: Month 6 after first treatment
best-corrected visual acuity (BCVA) at month 12
best-corrected visual acuity (BCVA) at month 12
Time frame: Month 12 after first treatment
the number of intravitreal injections of Ranibizumab at month 12
the number of intravitreal injections of Ranibizumab at month 12
Time frame: Month 12 after first treatment
best-corrected visual acuity (BCVA) during the follow-up
best-corrected visual acuity (BCVA) during the follow-up
Time frame: during the follow-up for up to 12 months.
intraocular pressure during the follow-up
intraocular pressure during the follow-up
Time frame: during the follow-up for up to 12 months.
central macular thickness during the follow-up
central macular thickness during the follow-up
Time frame: during the follow-up for up to 12 months.
posterior choroidal thickness during the follow-up
posterior choroidal thickness during the follow-up
Time frame: during the follow-up for up to 12 months.
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.
Time frame: during the follow-up for up to 12 months.
Fundus fluorescein angiography (FFA) examination results during the follow-up
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.
Microperimetry during the follow-up
Changes in posterior pole found by microperimetry
Time frame: during the follow-up for up to 12 months.
Electroretinogram (ERG) during the follow-up
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.
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.
Time frame: during the follow-up for up to 12 months.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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