Evaluating of the Safety, Pharmacokinetics and Pharmacodynamics of QL1205 and Lucentis® in Patients With Wet AMD

Q

Qilu Pharmaceutical

Status and phase

Completed
Phase 1

Conditions

Wet Age-related Macular Degeneration

Treatments

Drug: QL1205
Drug: lucentis

Study type

Interventional

Funder types

Industry

Identifiers

NCT03312283
QL1205-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

48 participants in 2 patient groups

QL1205
Experimental group
Description:
QL1205 injection (0.5mg) by vitreous injection once a month for three months(D1、D29、D57)
Treatment:
Drug: QL1205
Lucentis
Active Comparator group
Description:
Lucentis® injection(0.5mg) by vitreous injection once a month for three months(D1、D29、D57)
Treatment:
Drug: lucentis

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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