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
To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to pmCNV
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 Safety and efficacy outcomes will continue to be evaluated up to a period of 36 weeks unless the patient is withdrawn or discontinues the study.
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 →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.
Exclusion Criteria:
For Any Eye:
General Exclusion Criteria:
Laboratory Exclusion Criteria:
Other Exclusion Criteria:
601 1.25mg
Drug: 601
Ranibizuman 0.5 mg
Drug: Ranibizumab
intravitreal recombinant humanized anti-VEGF monoclonal antibody
intravitreal recombinant humanized anti-VEGF monoclonal antibody
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
Average Change of BCVA on each visit compared to baseline.
Assessed with ETDRS visual acuity testing charts.
Time frame: 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.
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
Assessed with ETDRS visual acuity testing charts.
Time frame: Baseline to Week 36
Number of injections from Week 4 to Week 36
Number of administered injections
Time frame: Week 4 to Week 36
Incidence of ocular and non-ocular AEs up to Week 36
Incidence of ocular and non-ocular AEs
Time frame: Baseline to Week 36
Blood concentrations of 601
Steady-state blood concentrations of 601
Time frame: Baseline, Week 4, Week 12, Week 24 and Week 36.
Blood concentrations of VEGF
Detection of VEGF blood concentration
Time frame: 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
Time frame: Baseline, Week 4, Week 12, Week 24 and Week 36.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions 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.
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.