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This is a randomized, double-blind, two-group parallel, positive-controlled clinical Phase I trial comparing the safety, pharmacokinetics and pharmacodynamics of QL1205 and Lucentis® in patients with wet age-related macular degeneration.
This is a phase I, randomized, double-blind, two-group parallel, positive-controlled clinical trial at four centers.
The primary objective is to assess the initial clinical safety of intravitreal injection of QL1205 or Lucentis® in patients with wet age-related macular degeneration (wet-AMD).
The secondary objective are to assess the initial clinical effectiveness and pharmacokinetic characteristics of intravitreal injection of QL1205 or Lucentis® in patients with wet age-related macular degeneration (wet-AMD).
Subjects would sequentially enrolled according to the protocol in one of two cohorts.Subjects would receive a single 0.5mg of QL1205 or Lucentis® once a month for three months through vitreous injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1205 | Experimental | QL1205 injection (0.5mg) by vitreous injection once a month for three months(D1、D29、D57) |
|
| Lucentis | Active Comparator | Lucentis® injection(0.5mg) by vitreous injection once a month for three months(D1、D29、D57) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lucentis | Drug | intravitreal injection of 0.5 mg (0.05 ml), Q4W, continuous administration for 3 times (D1, D29, D57) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of QL1205 | To evaluate the safety of QL1205, compared to that of Lucentis (registered trademark) in patients with neovascular AMD.This will be done by assessment of vital signs, physical examination, laboratory blood tests and adverse events. | 85 days |
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Inclusion Criteria:
Note: If the subject's eyes both meet the inclusion criteria, the investigator will determines the target eye from a medical point of view.
Exclusion Criteria:
Patients with any of the following eye conditions:
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| Name | Affiliation | Role |
|---|---|---|
| Xun Xu, professor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| mingwei zhao, professor | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200000 | 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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| QL1205 | Drug | intravitreal injection of 0.5 mg (0.05 ml), Q4W, continuous administration for 3 times (D1, D29, D57) |
|
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |