CClinicalTrials.gg
Status unknownNCT04922151Updated Jun 10, 2021

601 Versus Ranibizumab in Patients With Pathological Myopic Choroidal Neovascularization (pmCNV)

A Phase 2 interventional study of 601 and Ranibizumab in Pathological Myopic Choroidal Neovascularization, sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-10.

Sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Following a 14-day maximum screening period, patients will be randomized and followed for approximately 36 weeks. Treatment visits will be scheduled in 4-week intervals. After 1 initial injection of 601 or ranibizumab (loading phase), subjects will enter an individualized flexible treatment (IFT) phase (week 4 to week 32). 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 Safety and efficacy outcomes will continue to be evaluated up to a period of 36 weeks unless the patient is withdrawn or discontinues the study.

02

Conditions studied

  • Pathological Myopic Choroidal Neovascularization

Keywords

  • VEGF; pmCNV; antibody
03

In context

Choroidal Neovascularization

188 studies on the registry are indexed under Choroidal Neovascularization; 12 are open to participants now.

This study's planned enrollment of 60 is above the median of 54 across 138 interventional studies indexed under Choroidal Neovascularization.

Browse Choroidal Neovascularization studies →

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. is the lead sponsor of 56 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 active choroidal neovascularization secondary to pathological myopia
  • BCVA score between 78 and 24 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/320)
  • 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)

Exclusion criteria

Exclusion Criteria:

  • CNV secondary to other causes (except pathological myopia), such as neovascularage-related macular degeneration (nAMD), polypoid choroidal vascular disease (PCV), and secondary injury
  • The fovea has fibrosis and organochemical foci or scar or atrophy that obviously involves the fovea and causes irreversible vision loss;
  • 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 enrollment;
  • PDT, Macular laser photocoagulation (focal/grid), vitrectomy or keratoplasty in the study eye at any time prior to baseline. Panretinal 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
  • 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)
  • 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.
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    group I

    601 1.25mg

    Drug: 601

  • Active comparator
    group II

    Ranibizuman 0.5 mg

    Drug: Ranibizumab

Interventions

  • Drug601

    intravitreal recombinant humanized anti-VEGF monoclonal antibody

  • DrugRanibizumab

    intravitreal recombinant humanized anti-VEGF monoclonal antibody

06

What researchers measure

Primary outcomes

  1. Change from baseline in best-corrected visual acuity (BCVA) at Week 12

    Assessed with ETDRS visual acuity testing charts.

    Time frame: Baseline to Week 12

Secondary outcomes

  1. Average Change of BCVA on each visit compared to baseline.

    Assessed with ETDRS visual acuity testing charts.

    Time frame: Baseline to Week 36

  2. Change from baseline in central retina thickness (CRT) on each visit

    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.

    Time frame: Baseline to Week 36

  3. Proportion of study eyes with a gain ≥ 5, 10 and 15 letters in BCVA on each visit compared to baseline

    Assessed with ETDRS visual acuity testing charts.

    Time frame: Baseline to Week 36

  4. Number of injections from Week 4 to Week 36

    Number of administered injections

    Time frame: Week 4 to Week 36

  5. Incidence of ocular and non-ocular AEs up to Week 36

    Incidence of ocular and non-ocular AEs

    Time frame: Baseline to Week 36

  6. Blood concentrations of 601

    Steady-state blood concentrations of 601

    Time frame: Baseline, Week 4, Week 12, Week 24 and Week 36.

  7. Blood concentrations of VEGF

    Detection of VEGF blood concentration

    Time frame: Baseline, Week 4, Week 12, Week 24 and Week 36.

  8. Immunogenicity of 601

    Detection of blood Anti-drug antibody (ADA) status. If ADA was positive, Neutralization antibody (Nab) will be tested

    Time frame: Baseline, Week 4, Week 12, Week 24 and Week 36.

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    BeiJing, China
    • YouXin Chen, PhD · Contact
    • YouXin Chen, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04922151
Lead sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Responsible party
Sponsor
First posted
Jun 10, 2021
Start date
Jun 4, 2021
Primary completion
Jan 31, 2023 (estimated)
Completion
Jul 31, 2023 (estimated)
Last update
Jun 10, 2021

Study contacts

YouXin Chen, PhD
Contact
Chenyouxinpumch@163.com
+86-010-65296358
YouXin Chen, PHD
principal investigator · Peking Union Medical College Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion