Pathological Myopic Choroidal NeovascularizationPhase 2NCT04922151
601 Versus Ranibizumab in Patients With Pathological Myopic Choroidal Neovascularization (pmCNV)
A Phase 2 study testing 601 and Ranibizumab in people with Pathological Myopic Choroidal Neovascularization, 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 pmCNV Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathological Myopic Choroidal Neovascularization
- What is being tested?
- 601 and Ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2021to 31 Jul 2023
- 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 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)
Who cannot join
- 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:
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
YouXin Chen, PhD
YouXin Chen, PhD
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 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
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.
- Being tested
- 601, Ranibizumab
- Keywords
- VEGF; pmCNV; antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
601Drug
intravitreal recombinant humanized anti-VEGF monoclonal antibody
RanibizumabDrug
intravitreal recombinant humanized anti-VEGF monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| group I | Experimental | 601 1.25mg Receives: Drug: 601 |
| group II | Active comparator | Ranibizuman 0.5 mg Receives: Drug: Ranibizumab |
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 12
Assessed with ETDRS visual acuity testing charts.
Measured: Baseline to Week 12
Secondary outcomes (8)
Average Change of BCVA on each visit compared to baseline.
Assessed with ETDRS visual acuity testing charts.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 36
Number of injections from Week 4 to Week 36
Number of administered injections
Measured: Week 4 to Week 36
Incidence of ocular and non-ocular AEs up to Week 36
Incidence of ocular and non-ocular AEs
Measured: Baseline to Week 36
Blood concentrations of 601
Steady-state blood concentrations of 601
Measured: Baseline, Week 4, Week 12, Week 24 and Week 36.
Blood concentrations of VEGF
Detection of VEGF blood concentration
Measured: 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
Measured: Baseline, Week 4, Week 12, Week 24 and Week 36.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start4 Jun 2021
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological Myopic Choroidal NeovascularizationStudies 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 (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- YouXin Chen, PHD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922151
- Sponsor's protocol ID
- SSGJ-601-pmCNV-II-01
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 10 Jun 2021
- 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 10 Jun 2021. 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 Pathological Myopic Choroidal Neovascularization (pmCNV)
- ClinicalTrials.gov ID
- NCT04922151
- Acronym / sponsor ID
- SSGJ-601-pmCNV-II-01
- Keywords
- VEGF; pmCNV; antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 10 Jun 2021 (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 pmCNV
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Experimental | Drug: 601601 1.25mg |
| group II | Active comparator | Drug: RanibizumabRanibizuman 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 (7 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
- 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)
Key exclusion criteria (20 listed)
- 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)
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 |
|---|---|---|
| 601intravitreal recombinant humanized anti-VEGF monoclonal antibody | Drug | group I |
| Ranibizumabintravitreal recombinant humanized anti-VEGF monoclonal antibody | Drug | group II |
Primary outcome
Change from baseline in best-corrected visual acuity (BCVA) at Week 12
Time frame: Baseline to Week 12
Assessed with ETDRS visual acuity testing charts.
8 secondary outcomes
Average Change of BCVA on each visit compared to baseline.
Time frame: Baseline to Week 36
Change from baseline in central retina thickness (CRT) on each visit
Time frame: Baseline to Week 36
Proportion of study eyes with a gain ≥ 5, 10 and 15 letters in BCVA on each visit compared to baseline
Time frame: Baseline to Week 36
Number of injections from Week 4 to Week 36
Time frame: Week 4 to Week 36
Incidence of ocular and non-ocular AEs up to Week 36
Time frame: Baseline to Week 36
Blood concentrations of 601
Time frame: Baseline, Week 4, Week 12, Week 24 and Week 36.
Blood concentrations of VEGF
Time frame: Baseline, Week 4, Week 12, Week 24 and Week 36.
Immunogenicity of 601
Time frame: Baseline, Week 4, Week 12, Week 24 and Week 36.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Pathological Myopic Choroidal Neovascularization
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The Treatment Burden of Myopic Choroidal Neovascularization
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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.
YouXin Chen, PHD principal investigator
Peking Union Medical College 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 and Ranibizumab in people with Pathological Myopic Choroidal Neovascularization, 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 7 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 10 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YouXin Chen, PhD (+86-010-65296358, Chenyouxinpumch@163.com), or a site near the patient. 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 12 (time frame: Baseline to Week 12). 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 10 Jun 2021.