601 Versus Ranibizumab in Patients With Central Retinal Vein Occlusion (CRVO)

NCT04667910 | Completed Phase 2

• 1 other identifier: SSGJ-601-CRVO-II-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to macular edema secondary to CRVO

Conditions

Central Retinal Vein Occlusion

Keywords

VEGF; BRVO; antibody

Outcome Measures

Primary Outcomes (1)

• Change from baseline in best-corrected visual acuity (BCVA) at Week 24

  Assessed with ETDRS visual acuity testing charts.

  Baseline to Week 24

Secondary Outcomes (11)

• Change from baseline in BCVA by visit up to Week 12 and Week 52

  Baseline, Week 12 and Week 52

• Proportion of study eyes with a gain ≥ 5, 10 and 15 letters in BCVA by at Week 12, Week 24 and Week 52 compared to baseline

  ：Baseline, Week 12, Week 24 and Week 52

• Average Change of BCVA From Baseline to Week 4 Through Week 52

  Baseline to Week 52

• Average Change of BCVA From Baseline to Week 28 Through Week 52

  Week 28 to Week 52

• Change from baseline in central retina thickness (CRT) at Week 12, Week 24 and Week 52

  baseline, Week 12, Week 24 and Week 52

Study Arms (2)

601 1.25mg

EXPERIMENTAL

Drug: 601 1.25mg

Ranibizuman 0.5 mg

EXPERIMENTAL

Drug: Ranibizuman 0.5 mg

Interventions

601 1.25mg DRUG

Solution for injection (intravitreal use)

Also known as: Drug 601

601 1.25mg

Ranibizuman 0.5 mg DRUG

Solution for injection (intravitreal use)

Also known as: Lucentis

Ranibizuman 0.5 mg

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 visited 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 central retinal vein occlusion within 12 months
• BCVA score between 78 and 19 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/400)
• CRT ≥ 250μm
• No optometric media opacity and pupil abnormal
• BCVA score ≥ 34 letters in the fellow eye, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/200)

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 first 12-month study period (e.g. scarring, fibrosis or atrophy of the fovea, dense subfoveal hard exudates, significant hemorrhage obscuring the macular, vitreous hemorrhage, vitreomacular traction, retinal vascular occlusion other than CRVO, retinal detachment, macular hole, or age-related macular degeneration，choroidal neovascularization of any cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular edema). Hemiretinal vein occlusion (HRVO) should be excluded
• iris, chamber angle neovascularization or retinal, optic disc neovascularization
• Previous use of intraocular or periocular steroids within 3 months prior to baseline, or previous use of dexamethasone intravitreal implant within 6 months prior to baseline
• Macular laser photocoagulation (focal/grid)，panretinal laser photocoagulation，vitrectomy，radial optic neurotomy arteriovenous sheathotomy，trabeculectomy or keratoplasty in the study eye at any time prior to baseline. Local laser photocoagulation, YAG laser treatment or any other ocular surgeries (e.g. cataract surgery ) in the study eye within 3 months prior to the baseline
• During the screening period, the BCVA is \>10 letters improved (the BCVA detected within 24 hours before the administration at day 0 compared with the BCVA at the screening)
• Aphakia (except IOL) or posterior capsular defect (except YAG posterior capsulotomy after intraocular lens implantation surgery)
• For Any Eye:
• Any eye has active ocular infections (e.g. blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis)
• Uncontrollable glaucoma (defined as intraocular pressure after antiglaucoma therapy\>= 25 mm Hg), or the cup/disk ratio \>0.8 in the study 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
• Diagnosed systemic immune diseases (e.g. ankylosing spondylitis, systemic lupus erythematosus, Behcet's disease, rheumatoid arthritis, scleroderma etc.)
• any uncontrolled clinical problem (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.

Sponsors & Collaborators

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

Study Sites (1)

TianJing Medical University Eye Hospital

Tianjing, TianJing, 300384, China

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Xiao rong Li, MD

  TianJing Medical University Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: December 8, 2020
• First Posted: December 16, 2020
• Study Start: January 27, 2021
• Primary Completion: November 16, 2022
• Study Completion: November 16, 2022
• Last Updated: June 27, 2025

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)