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Safety and Efficacy by Multiple Injection of KH902 in Patients With Diabetic Macular Edema (DME) (Frontier-1)

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
KH902
Sponsored by
Chengdu Kanghong Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring KH902, Diabetic macular Edema, Intravitreal injection, Multiple injections, 20 patients, 0.5mg/eye/time

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed the Informed Consent Form and willing to comply with study procedures;
  • 18 years old ≦ either gender ≦ 75 years old;
  • Confirmed diagnosed with Type 1 diabetes or Type 2 diabetes based on the diabetes diagnosis criteria;

  • Clinically significant DME:

    • Hard exudation within 500μm of the central foveal diameter accompanied with contiguous retina thickening;
    • The edema locates within 500μm of the central foveal diameter;
    • Retina thickening field > 1DD and within the 1DD central fovea.
  • BCVA score of the study eyes between 78 and 19 letters, inclusively, and the BCVA score of fellow eyes ≥ 24 letters;
  • Previous treatment of antidiabetic drugs within three months preceding the screening, and blood-glucose concentration is predicted to be unchanged and stable during the whole study.

Exclusion Criteria:

  • Uncontrolled glaucoma in either eye;
  • Currently active ocular inflammation or infection in either eye;
  • Macular edema in the study eye was caused by other diseases rather than diabetes;
  • Company with any other ocular conditions failing to prevent vision loss despite improving the macular edema;
  • Any other ocular diseases which may cause macular edema or vision alteration during study phase;
  • Retinal macular traction or macular epiretinal membrane in study eye;
  • Refractive error equate or exceed 8 diopters of myopia in study eye
  • Whole or regional retinal laser photocoagulation has been applied in study eye within 6 months preceding the screening;
  • Previous anti-VEGF drug treatment in study eye;
  • Intraocular or periocular injection of steroid drug within 6 months preceding the screening;
  • Previous ophthalmologic operation within 3 months preceding the screening and/or planning to receive an ophthalmologic operation during the study.
  • There is any potential for the study eye to receive the panretinal laser photocoagulation treatment during the study;
  • Previous vitrectomy in study eye.
  • Uncontrolled diabetes;
  • Hypertensive patients with poorly controlled blood pressure;
  • Uncontrolled systemic infectious diseases;
  • Systemic immune diseases;
  • History of allergy;
  • Any uncontrolled clinical disorders;
  • Pregnant or nursing women;
  • Adopt one or more adequate contraception methods.

Sites / Locations

  • Shanghai First People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

Patients will receive an intravitreal injection of 0.5mg KH902 in the study eye at the first month, following the fixed injection, patients will continue to receive injection of KH902 at the same dose on an as needed (PRN) dosing schedule based upon the monthly physician assessment of the need for re-treatment in accordance with pre-specified criteria.

Patients will receive continuously monthly intravitreal injections of 0.5 mg KH902 for 3 times in the study eye; following the initial 3-month fixed-dosing phase of the trial, patients will continue to receive injection of KH902 at the same dose on an as needed (PRN) dosing schedule based upon the monthly physician assessment of the need for re-treatment in accordance with pre-specified criteria.

Outcomes

Primary Outcome Measures

Incidence rate of adverse event
To evaluate the safety of multiple intravitreal injection of KH902 to treat DME.

Secondary Outcome Measures

Change from Baseline in BCVA
To evaluate the efficacy of multiple intravitreal injection of KH902 of each group.

Full Information

First Posted
March 15, 2011
Last Updated
February 28, 2013
Sponsor
Chengdu Kanghong Biotech Co., Ltd.
Collaborators
University of Wisconsin, Madison, Teaching and Research Office of Health Statistics, Fourth Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01324869
Brief Title
Safety and Efficacy by Multiple Injection of KH902 in Patients With Diabetic Macular Edema (DME)
Acronym
Frontier-1
Official Title
An Open-label, Randomized, Uncontrolled, Preliminary Clinical Study to Evaluate the Safety and Efficacy of KH902 Following Multiple Intravitreal Injection in Patients With Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu Kanghong Biotech Co., Ltd.
Collaborators
University of Wisconsin, Madison, Teaching and Research Office of Health Statistics, Fourth Military Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to access the safety and efficacy of multiple injections of KH902 in patients with Diabetic Macular Edema (DME).
Detailed Description
With improvement of our living standard, patients who suffered from Diabetes become more and more. As the investigators know, Diabetes can induce many ocular diseases leading to vision loss. And according to observations, DME is diagnosed as one main cause of vision loss in the patients with Diabetes. As the results of many studies conducted previously, anti-VEGF drugs and anti-VEGF treatments show its effect and safety not only in treating AMD, but also in patients with DME. The new drug Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902) is a gene fusion protein. The previous clinical trials of KH902 show that KH902 is effective and safe in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF. Due to these positive results, the investigators prepare to conduct a clinical trial to assess the safety and efficacy with intravitreal injection of KH902 in patients with DME.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
KH902, Diabetic macular Edema, Intravitreal injection, Multiple injections, 20 patients, 0.5mg/eye/time

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Patients will receive an intravitreal injection of 0.5mg KH902 in the study eye at the first month, following the fixed injection, patients will continue to receive injection of KH902 at the same dose on an as needed (PRN) dosing schedule based upon the monthly physician assessment of the need for re-treatment in accordance with pre-specified criteria.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Patients will receive continuously monthly intravitreal injections of 0.5 mg KH902 for 3 times in the study eye; following the initial 3-month fixed-dosing phase of the trial, patients will continue to receive injection of KH902 at the same dose on an as needed (PRN) dosing schedule based upon the monthly physician assessment of the need for re-treatment in accordance with pre-specified criteria.
Intervention Type
Biological
Intervention Name(s)
KH902
Intervention Description
Intravitreal injection of 0.5mg/eye/time KH902
Primary Outcome Measure Information:
Title
Incidence rate of adverse event
Description
To evaluate the safety of multiple intravitreal injection of KH902 to treat DME.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Change from Baseline in BCVA
Description
To evaluate the efficacy of multiple intravitreal injection of KH902 of each group.
Time Frame
at the end of month 3 and the end of month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed the Informed Consent Form and willing to comply with study procedures; 18 years old ≦ either gender ≦ 75 years old; Confirmed diagnosed with Type 1 diabetes or Type 2 diabetes based on the diabetes diagnosis criteria; Clinically significant DME: Hard exudation within 500μm of the central foveal diameter accompanied with contiguous retina thickening; The edema locates within 500μm of the central foveal diameter; Retina thickening field > 1DD and within the 1DD central fovea. BCVA score of the study eyes between 78 and 19 letters, inclusively, and the BCVA score of fellow eyes ≥ 24 letters; Previous treatment of antidiabetic drugs within three months preceding the screening, and blood-glucose concentration is predicted to be unchanged and stable during the whole study. Exclusion Criteria: Uncontrolled glaucoma in either eye; Currently active ocular inflammation or infection in either eye; Macular edema in the study eye was caused by other diseases rather than diabetes; Company with any other ocular conditions failing to prevent vision loss despite improving the macular edema; Any other ocular diseases which may cause macular edema or vision alteration during study phase; Retinal macular traction or macular epiretinal membrane in study eye; Refractive error equate or exceed 8 diopters of myopia in study eye Whole or regional retinal laser photocoagulation has been applied in study eye within 6 months preceding the screening; Previous anti-VEGF drug treatment in study eye; Intraocular or periocular injection of steroid drug within 6 months preceding the screening; Previous ophthalmologic operation within 3 months preceding the screening and/or planning to receive an ophthalmologic operation during the study. There is any potential for the study eye to receive the panretinal laser photocoagulation treatment during the study; Previous vitrectomy in study eye. Uncontrolled diabetes; Hypertensive patients with poorly controlled blood pressure; Uncontrolled systemic infectious diseases; Systemic immune diseases; History of allergy; Any uncontrolled clinical disorders; Pregnant or nursing women; Adopt one or more adequate contraception methods.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xun Xu
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lun De Luo
Organizational Affiliation
Chengdu Kanghong Biotech Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai First People's Hospital
City
Shanghai
ZIP/Postal Code
200125
Country
China

12. IPD Sharing Statement

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Safety and Efficacy by Multiple Injection of KH902 in Patients With Diabetic Macular Edema (DME)

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