Patients clinically diagnosed with macular edema secondary to retinal vein occlusion (RVO), including branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO), where hemiretinal vein occlusion (HRVO) is categorized as CRVO
Conditions
Interventions
Renzumab Combined with Blood-Activating and Stasis-Resolving Drug Treatment Group:Renzumab Injection (Qilu Pharmaceutical, 10mg/mL): Intravitreal injection, initial once per month, 0.05ml (0.5mg) per
oral blood-activating and stasis-resolving drugs (Fufang Xueshuantong Capsules or Xuefu Zhuyu Pills/Capsules), dosing according to the instructions, starting from randomization, treatment duration at
Renzumab Monotherapy Group:Renzumab Injection (Qilu Pharmaceutical, 10mg/mL): Intravitreal injection, initial once per month, 0.05ml (0.5mg) per dose, continuous for 3 doses, then as needed (PRN)
no oral blood-activating and stasis-resolving drugs administered during the study period.
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 40 to 80 years (inclusive), with no restrictions on sex; 2. Clinically diagnosed with retinal vein occlusion (RVO), encompassing both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO), where hemiretinal vein occlusion (HRVO) is categorized as CRVO; and must present with retinal hemorrhages; 3. Non-ischemic retinal vein occlusion; 4. Documented presence of macular edema causing visual impairment; 5. The study eye must have a BCVA between 3.7 and 4.7 (inclusive), equivalent to 0.05-0.5 on the standard logarithmic visual acuity chart; 6. Study eye with central retinal thickness (CRT) >=300µm as shown on OCT; 7. Unilateral disease; 8. Subjects of childbearing potential (both male and female) must agree to use an acceptable method of contraception during their participation in the study; 9. Voluntarily signs the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. The study eye has received intravitreal anti-VEGF therapy within the past 3 months; or intravitreal or periocular corticosteroid injection (e.g., Ozurdex or triamcinolone acetonide) within the past 6 months; 2. The study eye has previously received intravitreal long-acting corticosteroid implants (including fluocinolone acetonide intravitreal implant (Iluvien), etc.); 3. Current use of medications for treating retinal hemorrhages due to RVO (e.g., Compound Xueshuantong Capsules, Hexue Mingmu Tablets, Maixuekang Capsules, Zhixue Quyu Mingmu Tablets) for more than 4 weeks; 4. The study eye has other vision-affecting ocular diseases, such as diabetic retinopathy, age-related macular degeneration, macular hole, epiretinal membrane, macular atrophy, retinal artery occlusion, or retinal detachment; 5. History of ocular trauma in the study eye; 6. Cataract surgery in the study eye within 3 months prior to screening, or YAG laser posterior capsulotomy or laser peripheral iridotomy (LPI) within 1 month; 7. Active periocular or ocular infection in the study eye; 8. Uncontrolled glaucoma or ocular hypertension in the study eye (IOP >25 mmHg despite treatment with >=2 IOP-lowering medications), or history of steroid-induced ocular hypertension; 9. Ocular conditions in the study eye that affect fundus examination or OCT imaging, such as significant corneal disease, severe cataract, or vitreous hemorrhage; 10. Systemic conditions unsuitable for surgery, such as myocardial infarction or cerebrovascular disease occurring within the last 6 months, severe systemic diseases, or any uncontrolled systemic disease. 11. Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULN, serum creatinine (Cr) > 1.2 × ULN, coagulation abnormalities (prothrombin time (PT) >= 3 seconds above the upper limit of normal, or activated partial thromboplastin time (APTT) >= 10 seconds above the upper limit of normal) at screening, which are considered clinically significant by the investigator. 12. Female patients who are breastfeeding or pregnant; 13. Known allergy to the study drugs (ranibizumab), drugs for promoting blood circulation and removing blood stasis, or contrast agents; 14. Participation in another drug clinical trial within the past 3 months; 15. Any other condition deemed by the investigator to make the subject unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in central retinal thickness (CRT) from baseline at 3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with CRT reduced to below 300 µm at month 1;Change in best-corrected visual acuity (BCVA) from baseline at months 3, 6, 9, and 12;Change in central retinal thickness (CRT) from baseline at months 6, 9, and 12;Change in retinal hemorrhage area from baseline at month 3;Proportion of patients with resolution of intraretinal fluid and subretinal fluid at months 6 and 12;Proportion of patients with disruption of inner retinal layers (DRIL) at months 6 and 12;Number of intravitreal injections of ranibizumab within 12 months; | — |
Countries
China
Contacts
Public ContactSun Zuhua
Eye Hospital, Wenzhou Medical University
Outcome results
None listed