Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion (NCT04062370) | Clinical Trial Compass
UnknownPhase 4
Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion
China100 participantsStarted 2019-10-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
â. Patients with RVO-ME diagnosed definitely by FFA and OCT, with CMT \> 300Ξm; BCVA from 20/200 to 20/40 (including 20/200 and 20/40), with a degree of myopia âĪ-6 diopter (diopter, D);
â. Patients with a course of RVO âĪ 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;
â. 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
â. Patients with a course of disease \> 12 weeks;
â. 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;
â. Patients with their study eyes treated with panretinal photocoagulation (PRP) previously;
â. Patients previously participating in other clinical trials 3 months before the baseline;
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What they're measuring
1
best-corrected visual acuity (BCVA) at month 6
Timeframe: Month 6 after first treatment
2
Central macular thickness (CMT) at month 6 (3) the number of intravitreal injections of Ranibizumab at month 6
Timeframe: Month 6 after first treatment
3
the number of intravitreal injections of Ranibizumab at month 6
. Patients with severely opacity of refractive media affecting laser treatment and observation;
â. Patients with other ophthalmic diseases affecting visual prognosis, such as corneal disease, glaucoma, severe cataract, uveitis, other fundus diseases, etc.
â. Patients with in any condition where intravitreal injection is unacceptable;
â. 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.