Retinal Vein Occlusion Clinical Trial
Official title:
Different Regimens of Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion: a Randomized and Controlled Clinical Study.
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | August 31, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
China | Chuangxin Huang | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | |
Other | intraocular pressure during the follow-up | intraocular pressure during the follow-up | during the follow-up for up to 12 months. | |
Other | central macular thickness during the follow-up | central macular thickness during the follow-up | during the follow-up for up to 12 months. | |
Other | posterior choroidal thickness during the follow-up | posterior choroidal thickness during the follow-up | during the follow-up for up to 12 months. | |
Other | 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. | |
Other | 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. | |
Other | Microperimetry during the follow-up | Changes in posterior pole found by microperimetry | during the follow-up for up to 12 months. | |
Other | 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. | |
Other | 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. | |
Primary | best-corrected visual acuity (BCVA) at month 6 | best-corrected visual acuity (BCVA) at month 6 | Month 6 after first treatment | |
Primary | 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 | |
Primary | 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 | |
Secondary | best-corrected visual acuity (BCVA) at month 12 | best-corrected visual acuity (BCVA) at month 12 | Month 12 after first treatment | |
Secondary | the number of intravitreal injections of Ranibizumab at month 12 | the number of intravitreal injections of Ranibizumab at month 12 | Month 12 after first treatment |
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