Central Retinal Vein OcclusionPhase 2NCT04667910
601 Versus Ranibizumab in Patients With Central Retinal Vein Occlusion (CRVO)
A Phase 2 study testing 601 1.25mg and Ranibizuman 0.5 mg in people with Central Retinal Vein Occlusion, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Retinal Vein Occlusion
- What is being tested?
- 601 1.25mg and Ranibizuman 0.5 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 27 Jan 2021to 16 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 27Show fewer
- 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
- General Exclusion Criteria:
- 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.
- Uncontrolled blood pressure control (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
- Laboratory Exclusion Criteria:
- 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);
- Other Exclusion Criteria:
- Non-use of effective contraception during childbearing age (except for women with spontaneous admonishment of more than 12 months)
- Pregnancy and lactation women
- 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;
- Researchers think it needs to be ruled out
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Masked, Multicenter, Phase II Study Assessing the Safety and Efficacy of 601 Versus Ranibizumab in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
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
Read the detailed description
Following a 14-day maximum screening period, patients will be randomized and followed for approximately 52 weeks. Treatment visits will be scheduled in 4-week intervals. After 6 initial monthly injections of 601 or ranibizumab (loading phase), subjects will enter an individualized flexible treatment (IFT) phase (week 24 to week 48). During the IFT phase, an assessment of disease stability will be performed at each monthly visit and subjects will receive either an injection or not. Safety and efficacy outcomes will continue to be evaluated up to a period of 52 weeks unless the patient is withdrawn or discontinues the study.
- Conditions
- Central Retinal Vein Occlusion
- Being tested
- 601 1.25mg, Ranibizuman 0.5 mg
- Keywords
- VEGF; BRVO; antibody
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
601 1.25mgDrug
Also called Drug 601
Solution for injection (intravitreal use)
Ranibizuman 0.5 mgDrug
Also called Lucentis
Solution for injection (intravitreal use)
| Study group | Role | What they receive |
|---|---|---|
| 601 1.25mg | Experimental | Not described Receives: Drug: 601 1.25mg |
| Ranibizuman 0.5 mg | Experimental | Not described Receives: Drug: Ranibizuman 0.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in best-corrected visual acuity (BCVA) at Week 24
Assessed with ETDRS visual acuity testing charts.
Measured: Baseline to Week 24
Secondary outcomes (11)
Change from baseline in BCVA by visit up to Week 12 and Week 52
Assessed with ETDRS visual acuity testing charts.
Measured: 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
Assessed with ETDRS visual acuity testing charts.
Measured: ：Baseline, Week 12, Week 24 and Week 52
Average Change of BCVA From Baseline to Week 4 Through Week 52
Assessed with ETDRS visual acuity testing charts.
Measured: Baseline to Week 52
Average Change of BCVA From Baseline to Week 28 Through Week 52
Assessed with ETDRS visual acuity testing charts.
Measured: Week 28 to Week 52
Change from baseline in central retina thickness (CRT) at Week 12, Week 24 and Week 52
OCT (optical coherence tomography) was used to assess central retina thickness (CRT) representing the average retinal thickness of the central 1 mm diameter subfield around the foveal center.
Measured: baseline, Week 12, Week 24 and Week 52
Number of injections from baseline to Week 52
Number of administered injections
Measured: baseline to Week 52
Number of injections between Week 24 to Week 52
Number of administered injections
Measured: Week 24 to Week 52
Incidence of ocular and non-ocular AEs up to Week 52
Incidence of ocular and non-ocular AEs
Measured: Baseline to Week 52
Blood concentrations of 601 at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24，Week 36 and Week 52
Steady-state blood concentrations of 601
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24，Week 36 and Week 52
Blood concentrations of VEGF at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24，Week 36 and Week 52
Detection of VEGF blood concentration.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24，Week 36 and Week 52
Immunogenicity of 601 at Baseline, Week 4, Week 12, Week 24, Week 36 and Week 52
Detection of blood Anti-drug antibody (ADA) status. If ADA was positive, Neutralization antibody (Nab) will be tested.
Measured: ：Baseline, Week 4, Week 12, Week 24, Week 36 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start27 Jan 2021
- Primary completion16 Nov 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Retinal Vein OcclusionStudies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiao rong Li, MD, Principal investigator, TianJing Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667910
- Sponsor's protocol ID
- SSGJ-601-CRVO-II-01
- Status last verified
- Nov 2022
- First submitted
- 8 Dec 2020
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Masked, Multicenter, Phase II Study Assessing the Safety and Efficacy of 601 Versus Ranibizumab in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
- ClinicalTrials.gov ID
- NCT04667910
- Acronym / sponsor ID
- SSGJ-601-CRVO-II-01
- Conditions
- Central Retinal Vein Occlusion
- Keywords
- VEGF; BRVO; antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Following a 14-day maximum screening period, patients will be randomized and followed for approximately 52 weeks. Treatment visits will be scheduled in 4-week intervals. After 6 initial monthly injections of 601 or ranibizumab (loading phase), subjects will enter an individualized flexible treatment (IFT) phase (week 24 to week 48). During the IFT phase, an assessment of disease stability will be performed at each monthly visit and subjects will receive either an injection or not. Safety and efficacy outcomes will continue to be evaluated up to a period of 52 weeks unless the patient is withdrawn or discontinues the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 601 1.25mg | Experimental | Drug: 601 1.25mg |
| Ranibizuman 0.5 mg | Experimental | Drug: Ranibizuman 0.5 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- BCVA score ≥ 34 letters in the fellow eye, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/200)
Key exclusion criteria (27 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 601 1.25mgAlso: Drug 601Solution for injection (intravitreal use) | Drug | 601 1.25mg |
| Ranibizuman 0.5 mgAlso: LucentisSolution for injection (intravitreal use) | Drug | Ranibizuman 0.5 mg |
Primary outcome
Change from baseline in best-corrected visual acuity (BCVA) at Week 24
Time frame: Baseline to Week 24
Assessed with ETDRS visual acuity testing charts.
11 secondary outcomes
Change from baseline in BCVA by visit up to Week 12 and Week 52
Time frame: 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
Time frame: ：Baseline, Week 12, Week 24 and Week 52
Average Change of BCVA From Baseline to Week 4 Through Week 52
Time frame: Baseline to Week 52
Average Change of BCVA From Baseline to Week 28 Through Week 52
Time frame: Week 28 to Week 52
Change from baseline in central retina thickness (CRT) at Week 12, Week 24 and Week 52
Time frame: baseline, Week 12, Week 24 and Week 52
Number of injections from baseline to Week 52
Time frame: baseline to Week 52
Number of injections between Week 24 to Week 52
Time frame: Week 24 to Week 52
Incidence of ocular and non-ocular AEs up to Week 52
Time frame: Baseline to Week 52
Blood concentrations of 601 at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24，Week 36 and Week 52
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24，Week 36 and Week 52
Blood concentrations of VEGF at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24，Week 36 and Week 52
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24，Week 36 and Week 52
Immunogenicity of 601 at Baseline, Week 4, Week 12, Week 24, Week 36 and Week 52
Time frame: ：Baseline, Week 4, Week 12, Week 24, Week 36 and Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao rong Li, MD principal investigator
TianJing Medical University Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 601 1.25mg and Ranibizuman 0.5 mg in people with Central Retinal Vein Occlusion, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in best-corrected visual acuity (BCVA) at Week 24 (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.