Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1+PRN | Experimental | 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. |
|
| 3+PRN | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| best-corrected visual acuity (BCVA) at month 6 | best-corrected visual acuity (BCVA) at month 6 | 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 | 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 | Month 6 after first treatment |
| Measure | Description | Time Frame |
|---|---|---|
| best-corrected visual acuity (BCVA) at month 12 | best-corrected visual acuity (BCVA) at month 12 | Month 12 after first treatment |
| the number of intravitreal injections of Ranibizumab at month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| intraocular pressure during the follow-up |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanjie Yan | Contact | +8620-87332529 | zocethics@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chenjin Jin, Ph.D | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chuangxin Huang | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25972260 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| laser photocoagulation | Device | After month 6, patients will received Ranibizumab PRN only or laser photocoagulation with Ranibizumab PRN according the re-randomization at month 6. |
|
the number of intravitreal injections of Ranibizumab at month 12
| Month 12 after first treatment |
intraocular pressure during the follow-up
| during the follow-up for up to 12 months. |
| central macular thickness during the follow-up | central macular thickness during the follow-up | during the follow-up for up to 12 months. |
| posterior choroidal thickness during the follow-up | posterior choroidal thickness during the follow-up | 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. | 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. | during the follow-up for up to 12 months. |
| Microperimetry during the follow-up | Changes in posterior pole found by microperimetry | 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 | 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. | during the follow-up for up to 12 months. |
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |