New eye drug 601 shows promise in major trial for blurry vision
NCT ID NCT05520177
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new medicine called 601 against an existing drug, ranibizumab, for people with vision loss due to a blocked vein in the eye (branch retinal vein occlusion). 351 adults received injections into the eye to reduce swelling and improve sight. The goal was to see if 601 works as well as the standard treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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351 people
The number who actually took part.
- Started
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Dec 2022
- Finished
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Sep 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Sign informed consent form and willing to be followed up at the time specified in the trial * Male or Female, at least 18 years of age * The study eye must meet the following criteria:Diagnosed with macular edema secondary to Branch retinal vein occlusion (BRVO) or Hemi-retinal vein occlusion (HRVO) within 12 months; BCVA score ≤ 73 and ≥19 letters using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/40 to 20/400); CRT ≥ 250μm; No optometric media opacity and pupil abnormal * BCVA score ≥ 34 ETDRS letters (approximate Snellen equivalent of 20/200) in the fellow eye, with no active RVO disease. Exclusion Criteria: * For Study Eye: Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 52-week study period * For Study Eye: iris, chamber angle neovascularization or retinal, optic disc neovascularization * For Study Eye: Previous use of intraocular or periocular steroids within 3 months prior to baseline, or dexamethasone intravitreal implant within 6 months prior to baseline * For Study Eye: Macular laser photocoagulation (focal/grid),panretinal laser photocoagulation,vitrectomy,trabeculectomy or keratoplasty in the study eye at any time prior to baseline. YAG laser treatment or any other intraocular surgeries (e.g. cataract surgery) in the study eye within 3 months prior to the baseline * For Study Eye: During the screening period, the BCVA is \>10 letters improved * For Study Eye: Aphakia (except IOL) or posterior capsular defect (except YAG posterior capsulotomy after intraocular lens implantation surgery) * For Any Eye: Active ocular infections (e.g. blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in any eye * For Any Eye: Uncontrolled glaucoma (defined as intraocular pressure after antiglaucoma therapy ≥ 25mmHg) in any eye, or the cup/disk ratio \>0.8 in the study eye * For Any Eye: History of intravitreal use of anti-VEGF drugs (e.g. ranibizumab,bevacizumab,aflibercept, conbercept, etc.) in any eye within 3 months prior to baseline * History of allergy to fluorescein sodium and allergies to protein products for treatment or diagnosis * History of stroke (cerebrovascular accident), myocardial infarction, active disseminated intravascular coagulation or pronounced bleeding tendency in the past 6 months prior to baseline * Systemic immune diseases (e.g. ankylosing spondylitis, systemic lupus erythematosus, Behcet's disease, rheumatoid arthritis, scleroderma etc.) * Any uncontrolled clinical conditions (e.g. AIDS, active hepatitis, serious mental, neurological, cardiovascular, respiratory and other systemic diseases or malignant tumors, etc.). Malignant tumors with no metastasis or recurrence within 5 years or cancers in situ cancers are not excluded. * Uncontrolled blood pressure (defined as systolic blood pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg after antihypertensive medication * History of surgery (except for healed minimally invasive surgery) and/or currently have unhealed wounds, moderate to severe ulcers, fractures, etc. within 1 month prior to baseline * History of system use of anti-VEGF drugs (e.g. bevacizumab) within 3 months prior to baseline * Liver dysfunction (ALT or AST is 2 times higher than the upper limit of normal value in the local laboratory). Renal function impairment (Cr is 1.5 times higher than the upper limit of normal values in the local laboratory) * Abnormal coagulation function (prothrombin time ≥ the upper limit of normal value for 3 seconds) and activated partial thromboplastin time ≥ the upper limit of normal value for 10 seconds). * Non-use of effective contraception during childbearing age (except for women with spontaneous admonishment of more than 12 months) * Women in pregnancy and lactation * Participation in clinical trials of any drug (except vitamins and minerals) or medical devices in the past 1 month or 5 half-lifes if the drug has a long half-life \>1 month prior to baseline. * Any conditions that researchers think it needs to be ruled out
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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BeiJing Hospital
Beijing, Beijing Municipality, 100730, China
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HeNan Provincial Eye Hospital
Zhengzhou, Henan, 450003, China
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JiangSu Province Hospital
Nanjing, Jiangsu, 210029, China
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ShangHai General Hospital
Shanghai, Shanghai Municipality, 200080, China
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The First Affiliated Hospital of JiNan University
Guangzhou, Guangdong, 510630, China
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The Second XiangYa Hospital of Central South University
Changsha, Hunan, 410011, China
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TianJin Eye Hospital
Tianjin, Tianjin Municipality, 300020, China
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TianJin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300384, China
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West China Hospital of Sichuan University
Chengdu, Sichuan, 610000, China
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ZheJiang Province People's Hospital
Hangzhou, Zhejiang, 310024, China
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Other studies related to the condition(s) this trial covers.
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