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

NCT ID: NCT03312283

Last Updated: 2019-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-20
• Study Completion Date: 2019-04-02

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.

Conditions

Wet Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

QL1205

QL1205 injection (0.5mg) by vitreous injection once a month for three months（D1、D29、D57）

Group Type: EXPERIMENTAL

QL1205

Intervention Type: DRUG

intravitreal injection of 0.5 mg (0.05 ml), Q4W, continuous administration for 3 times (D1, D29, D57)

Lucentis

Lucentis® injection(0.5mg) by vitreous injection once a month for three months（D1、D29、D57）

Group Type: ACTIVE_COMPARATOR

lucentis

Intervention Type: DRUG

intravitreal injection of 0.5 mg (0.05 ml), Q4W, continuous administration for 3 times (D1, D29, D57)

Interventions

lucentis

intravitreal injection of 0.5 mg (0.05 ml), Q4W, continuous administration for 3 times (D1, D29, D57)

Intervention Type: DRUG

QL1205

intravitreal injection of 0.5 mg (0.05 ml), Q4W, continuous administration for 3 times (D1, D29, D57)

Intervention Type: DRUG

Other Intervention Names

Ranibizumab Injection; Ranibizumab Injection

Eligibility Criteria

Inclusion Criteria

1. Sign the informed consent form, and willing to receive follow-up according to the time stipulated by the trial;

2. Aged ≥50 years or ≤80 years, male or female (including the boundary value);

3. 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;

4. The best corrected visual acuity of the subject's non-target eye is ≥19 letters (equivalent to Snellen visual acuity of 20/400).

Exclusion Criteria

Patients with any of the following eye conditions:

1. 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.);

2. The target eye's CNV is secondary to diseases other than AMD, such as trauma, pathological myopia,etc.;

3. Either eye has previously received drug treatment for CNV (e.g., Lucentis, Avastin, Eylea, Composin, Acaconac, triamcinolone, steroids, etc.)

4. 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;

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xun Xu, professor

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

mingwei zhao, professor

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

QL1205-001

Identifier Type: -

Identifier Source: org_study_id