A Phase III Study for 601 Versus Ranibizumab in Patients With Vision Loss

Launched by SUNSHINE GUOJIAN PHARMACEUTICAL (SHANGHAI) CO., LTD. · Aug 26, 2022

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ClinConnect Summary

This clinical trial is studying a new treatment called 601, which is being compared to a commonly used medication called Ranibizumab. Both treatments are aimed at helping patients who have vision loss due to a condition known as Branch Retinal Vein Occlusion (BRVO). The goal of the study is to see which treatment is more effective and safe for improving vision in people with swelling in the retina caused by this condition.

To participate in the trial, you need to be at least 18 years old and have been diagnosed with macular edema (swelling) linked to BRVO within the last year. Your vision should be somewhat impaired but still measurable. Participants will receive treatment and be monitored regularly for about a year. It's important to know that there are specific health conditions and recent treatments that might exclude someone from the trial, so it's best to discuss eligibility with your doctor. Overall, this trial aims to find out if the new treatment can provide better results for patients experiencing vision loss.

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Eligibility criteria

• 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