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

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 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.

Study Overview

• Status: Completed
• Conditions: Wet Age-related Macular Degeneration
• Intervention / Treatment: Drug: QL1205; Drug: lucentis

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

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:

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QL1205; QL1205 injection (0.5mg) by vitreous injection once a month for three months（D1、D29、D57）	Drug: QL1205; intravitreal injection of 0.5 mg (0.05 ml), Q4W, continuous administration for 3 times (D1, D29, D57); Other Names: Ranibizumab Injection
Active Comparator: Lucentis; Lucentis® injection(0.5mg) by vitreous injection once a month for three months（D1、D29、D57）	Drug: lucentis; intravitreal injection of 0.5 mg (0.05 ml), Q4W, continuous administration for 3 times (D1, D29, D57); Other Names: Ranibizumab Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Xun Xu, professor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Principal Investigator: mingwei zhao, professor, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2017
• Primary Completion (Actual): April 2, 2019
• Study Completion (Actual): April 2, 2019

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: QL1205-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No