To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to macular edema secondary to BRVO
Following a 14-day maximum screening period, patients will be randomized and followed for approximately 52 weeks. Treatment visits will be scheduled in 4-week intervals. After 6 initial monthly injections of 601 or ranibizumab (loading phase), subjects will enter an individualized flexible treatment (IFT) phase (week 24 to week 48). 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 Safety and efficacy outcomes will continue to be evaluated up to a period of 52 weeks unless the patient is withdrawn or discontinues the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Solution for injection (intravitreal use)
Solution for injection (intravitreal use)
BeiJing Hospital
Beijing, Beijing Municipality, China
Change from baseline in best-corrected visual acuity (BCVA) at Week 24
Assessed with ETDRS visual acuity testing charts.
Time frame: Baseline to Week 24
Change from baseline in BCVA by visit up to Week 12 and Week 52
Assessed with ETDRS visual acuity testing charts.
Time frame: Baseline, Week 12 and Week 52
Proportion of study eyes with a gain ≥ 5, 10 and 15 letters in BCVA by at Week 12, Week 24 and Week 52 compared to baseline
Assessed with ETDRS visual acuity testing charts.
Time frame: Baseline, Week 12, Week 24 and Week 52
Average Change of BCVA From Baseline to Week 4 Through Week 52
Assessed with ETDRS visual acuity testing charts.
Time frame: Baseline to Week 52
Average Change of BCVA From Baseline to Week 28 Through Week 52
Assessed with ETDRS visual acuity testing charts.
Time frame: Week 28 to Week 52
Change from baseline in central retina thickness (CRT) at Week 12, Week 24 and Week 52
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, Week 12, Week 24 and Week 52
Number of injections from baseline to Week 52
Number of administered injections
Time frame: baseline to Week 52
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Number of injections between Week 24 to Week 52
Number of administered injections
Time frame: Week 24 to Week 52
Incidence of ocular and non-ocular AEs up to Week 52
Incidence of ocular and non-ocular AEs
Time frame: Baseline to Week 52
Blood concentrations of 601 at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24,Week 36 and Week 52
Steady-state blood concentrations of 601
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24,Week 36 and Week 52
Blood concentrations of VEGF at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24,Week 36 and Week 52
Detection of VEGF blood concentration.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24,Week 36 and Week 52
Immunogenicity of 601 at Baseline, Week 4, Week 12, Week 24, Week 36 and Week 52
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, Week 36 and Week 52