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

NCT05520177 | Completed Phase 3

• 1 other identifier: SSGJ-601-BRVO-III-01
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 10

Brief Summary

To compare the efficacy and safety of recombinant humanized anti-VEGF monoclonal antibody (601) with Ranibizumab in patients with macular edema secondary to BRVO

Conditions

Branch Retinal Vein Occlusion

Keywords

Retinal Vein Occlusion; Macular Edema; Vascular Endothelial Growth Factor

Outcome Measures

Primary Outcomes (1)

• best-corrected visual acuity (BCVA)

  Assessed with Early treatment diabetic retinopathy study (ETDRS) visual acuity testing charts.

  From Baseline to Week 24

Secondary Outcomes (7)

• best-corrected visual acuity (BCVA)

  up to 52 weeks

• central retinal thickness (CRT)

  up to 52 weeks

• Number of injections

  up to 52 weeks

• Adverse Events (AEs)

  up to 52 weeks

• Steady-state Blood concentrations of 601 or ranibizumab

  up to 52 weeks

Study Arms (2)

601 1.25mg

EXPERIMENTAL

loading phase (6 months): 601 1.25mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses

Drug: 601 1.25mg

ranibizumab 0.5mg

ACTIVE COMPARATOR

loading phase (6 months): ranibizumab 0.5mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses

Drug: ranibizumab 0.5mg

Interventions

ranibizumab 0.5mg DRUG

loading phase (6 months): ranibizumab 0.5mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses

Also known as: Lucentis

ranibizumab 0.5mg

601 1.25mg DRUG

loading phase (6 months): 601 1.25mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses

Also known as: 601

601 1.25mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (10)

BeiJing Hospital

Beijing, Beijing Municipality, 100730, China

Location

The First Affiliated Hospital of JiNan University

Guangzhou, Guangdong, 510630, China

Location

HeNan Provincial Eye Hospital

Zhengzhou, Henan, 450003, China

Location

The Second XiangYa Hospital of Central South University

Changsha, Hunan, 410011, China

Location

JiangSu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

ShangHai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location

TianJin Eye Hospital

Tianjin, Tianjin Municipality, 300020, China

Location

TianJin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 300384, China

Location

ZheJiang Province People's Hospital

Hangzhou, Zhejiang, 310024, China

Location

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xiaorong Li, MD

  Tianjin Medical University Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 29, 2022
• Study Start: December 27, 2022
• Primary Completion: September 23, 2024
• Study Completion: September 23, 2024
• Last Updated: December 18, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)