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.
Overview
- Phase
- Phase 1
- Intervention
- QL1205
- Conditions
- Wet Age-related Macular Degeneration
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- To evaluate the safety of QL1205
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sign the informed consent form, and willing to receive follow-up according to the time stipulated by the trial;
- •Aged ≥50 years or ≤80 years, male or female (including the boundary value);
- •The target eye must meet the following requirements; Has newly occurring or relapsed subfoveal and perifoveal active choroidal neovascularization (CNV) lesions secondary to AMD; The total area of all types of lesions is ≤30 mm2(the area of 12 optic discs); The best corrected visual acuity is 78-19 letters (equivalent to Snellen visual acuity of 20/32 to 20/400); No refractive media opacity or myosis affecting fundus examination;
- •The best corrected visual acuity of the subject's non-target eye is ≥19 letters (equivalent to Snellen visual acuity of 20/400).
- •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:
- •The investigator judges that the target eye is currently suffering or used to suffer from non-exudative AMD disease affecting macular detection, or ocular diseases affecting central visual acuity (including central venous obstruction, diabetic retinopathy, uveitis, vascular striation, pathological myopia, retinal detachment, macular hole, etc.);
- •The target eye's CNV is secondary to diseases other than AMD, such as trauma, pathological myopia,etc.;
- •Either eye has previously received drug treatment for CNV (e.g., Lucentis, Avastin, Eylea, Composin, Acaconac, triamcinolone, steroids, etc.)
- •The target eye has subretinal hemorrhage, and hemorrhagic area is ≥ 50% of the total area of the lesion, or the subfoveal bleeding area is ≥ 1 optic disc area;
Arms & Interventions
QL1205
QL1205 injection (0.5mg) by vitreous injection once a month for three months（D1、D29、D57）
Intervention: QL1205
Lucentis
Lucentis® injection(0.5mg) by vitreous injection once a month for three months（D1、D29、D57）
Intervention: lucentis
Outcomes
Primary Outcomes
To evaluate the safety of QL1205
Time Frame: 85 days
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.