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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 Safety and efficacy outcomes will continue to be evaluated up to a period of 36 weeks unless the patient is withdrawn or discontinues the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group I | Experimental | 601 1.25mg |
|
| group II | Active Comparator | Ranibizuman 0.5 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 601 | Drug | intravitreal recombinant humanized anti-VEGF monoclonal antibody |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in best-corrected visual acuity (BCVA) at Week 12 | Assessed with ETDRS visual acuity testing charts. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change of BCVA on each visit compared to baseline. | Assessed with ETDRS visual acuity testing charts. | Baseline to Week 36 |
| Change from baseline in central retina thickness (CRT) on each visit |
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Inclusion Criteria:
Exclusion Criteria:
For Any Eye:
General Exclusion Criteria:
Laboratory Exclusion Criteria:
Other Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YouXin Chen, PhD | Contact | +86-010-65296358 | Chenyouxinpumch@163.com |
| Name | Affiliation | Role |
|---|---|---|
| YouXin Chen, PHD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Ranibizumab |
| Drug |
intravitreal recombinant humanized anti-VEGF monoclonal antibody |
|
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.
| 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. | Baseline to Week 36 |
| Number of injections from Week 4 to Week 36 | Number of administered injections | Week 4 to Week 36 |
| Incidence of ocular and non-ocular AEs up to Week 36 | Incidence of ocular and non-ocular AEs | Baseline to Week 36 |
| Blood concentrations of 601 | Steady-state blood concentrations of 601 | Baseline, Week 4, Week 12, Week 24 and Week 36. |
| Blood concentrations of VEGF | Detection of VEGF blood concentration | 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 | Baseline, Week 4, Week 12, Week 24 and Week 36. |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |