Status:
COMPLETED
Evaluating of the Safety, Pharmacokinetics and Pharmacodynamics of QL1205 and Lucentis® in Patients With Wet AMD
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Wet Age-related Macular Degeneration
Eligibility:
All Genders
50-80 years
Phase:
PHASE1
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 ...
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 inj...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03312283
Start Date
December 20 2017
End Date
April 2 2019
Last Update
April 11 2019
Active Locations (1)
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1
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200000