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

Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study ID
NCT04922151
Phase
PHASE2
Status
Unknown

Conditions

  • Pathological Myopic Choroidal Neovascularization

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 601 — DRUG
    intravitreal recombinant humanized anti-VEGF monoclonal antibody
  • Ranibizumab — DRUG
    intravitreal recombinant humanized anti-VEGF monoclonal antibody

Study Details

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

Key Dates

First listed
Jun 10, 2021
Start date
Jun 4, 2021
Status verified
Jun 2021
Primary completion
Jan 31, 2023
Completion
Jul 31, 2023

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: group I
    601 1.25mg
  • Active Comparator: group II
    Ranibizuman 0.5 mg

Primary Outcome Measure

Change from baseline in best-corrected visual acuity (BCVA) at Week 12 [ Time Frame: Baseline to Week 12 ]

Central Contacts