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

A Randomized, Double Masked, Multicenter, Phase II Study Assessing the Safety and Efficacy of 601 Versus Ranibizumab in Patients With Visual Impairment Due to Pathological Myopic Choroidal Neovascularization (pmCNV)

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

Study Overview

• Status: Recruiting
• Conditions: Pathological Myopic Choroidal Neovascularization
• Intervention / Treatment: Drug: 601; Drug: Ranibizumab

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 Safety and efficacy outcomes will continue to be evaluated up to a period of 36 weeks unless the patient is withdrawn or discontinues the study.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: YouXin Chen, PhD; Phone Number: +86-010-65296358; Email: Chenyouxinpumch@163.com

Study Locations

• China
  • BeiJing, China
    • Recruiting
    • Peking Union Medical College Hospital
    • Principal Investigator: YouXin Chen, PhD
    • Contact: YouXin Chen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group I; 601 1.25mg	Drug: 601; intravitreal recombinant humanized anti-VEGF monoclonal antibody
Active Comparator: group II; Ranibizuman 0.5 mg	Drug: Ranibizumab; intravitreal recombinant humanized anti-VEGF monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in best-corrected visual acuity (BCVA) at Week 12	Assessed with ETDRS visual acuity testing charts.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Change of BCVA on each visit compared to baseline.	Assessed with ETDRS visual acuity testing charts.	Baseline to Week 36
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.	Baseline to Week 36
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.	Baseline to Week 36
Number of injections from Week 4 to Week 36	Number of administered injections	Week 4 to Week 36
Incidence of ocular and non-ocular AEs up to Week 36	Incidence of ocular and non-ocular AEs	Baseline to Week 36
Blood concentrations of 601	Steady-state blood concentrations of 601	Baseline, Week 4, Week 12, Week 24 and Week 36.
Blood concentrations of VEGF	Detection of VEGF blood concentration	Baseline, Week 4, Week 12, Week 24 and Week 36.
Immunogenicity of 601	Detection of blood Anti-drug antibody (ADA) status. If ADA was positive, Neutralization antibody (Nab) will be tested	Baseline, Week 4, Week 12, Week 24 and Week 36.

Collaborators and Investigators

• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Investigators: Principal Investigator: YouXin Chen, PHD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2021
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: VEGF; pmCNV; antibody
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Uveal Diseases; Choroid Diseases; Refractive Errors; Metaplasia; Choroidal Neovascularization; Neovascularization, Pathologic; Myopia; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: SSGJ-601-pmCNV-II-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No