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 Safety and efficacy outcomes will continue to be evaluated up to a period of 36 weeks unless the patient is withdrawn or discontinues the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
intravitreal recombinant humanized anti-VEGF monoclonal antibody
intravitreal recombinant humanized anti-VEGF monoclonal antibody
Peking Union Medical College Hospital
Beijing, China
RECRUITINGChange 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
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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.