Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion

• Status: Not yet recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Ranibizumab

Criteria

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).