Efficacy and Safety of Ranibizumab Combined with Chinese Medicines for Promoting Blood Circulation and Removing Blood Stasis in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion: A Multicenter, Randomized Controlled Study.

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: 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 dose, continuous for 3 doses, then as needed (PRN); 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 least 3 months.;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.; CONDITION: 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; and presenting with retinal hemorrhages. PRIMARY OUTCOME: Change in central retinal thickness (CRT) from baseline at 3 months; SECONDARY OUTCOME: 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; 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.
Epistemonikos ID: d5da84f9d402873097c73b208f0736583ac1eaad
First added on: Jul 21, 2026