Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion
Retinal Vein Occlusion, Treatment, Photocoagulation Burn to Retina
About this trial
This is an interventional treatment trial for Retinal Vein Occlusion
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).
Sites / Locations
- Chuangxin Huang
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1+PRN
3+PRN
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.