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

This study has been completed.
Sponsor:
Collaborators:
University of Wisconsin, Madison
Teaching and Research Office of Health Statistics, Fourth Military Medical University
Information provided by (Responsible Party):
Chengdu Kanghong Biotech Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01324869
First received: March 15, 2011
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

This study is designed to access the safety and efficacy of multiple injections of KH902 in patients with Diabetic Macular Edema (DME).


Condition Intervention Phase
Diabetic Macular Edema
Biological: KH902
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chengdu Kanghong Biotech Co.,Ltd.:

Primary Outcome Measures:
  • Incidence rate of adverse event [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
    To evaluate the safety of multiple intravitreal injection of KH902 to treat DME.


Secondary Outcome Measures:
  • Change from Baseline in BCVA [ Time Frame: at the end of month 3 and the end of month 12 ] [ Designated as safety issue: No ]
    To evaluate the efficacy of multiple intravitreal injection of KH902 of each group.


Enrollment: 20
Study Start Date: April 2010
Study Completion Date: October 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
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.
Biological: KH902
Intravitreal injection of 0.5mg/eye/time KH902
Experimental: Group B
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.
Biological: KH902
Intravitreal injection of 0.5mg/eye/time KH902

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324869

Locations
China
Shanghai First People's Hospital
Shanghai, China, 200125
Sponsors and Collaborators
Chengdu Kanghong Biotech Co.,Ltd.
University of Wisconsin, Madison
Teaching and Research Office of Health Statistics, Fourth Military Medical University
Investigators
Principal Investigator: Xun Xu Shanghai First People's Hospital
Study Director: Lun De Luo Chengdu Kanghong Biotech Co.,Ltd.
  More Information

No publications provided

Responsible Party: Chengdu Kanghong Biotech Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01324869     History of Changes
Other Study ID Numbers: KHSWKH902002
Study First Received: March 15, 2011
Last Updated: February 28, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chengdu Kanghong Biotech Co.,Ltd.:
KH902
Diabetic macular Edema
Intravitreal injection
Multiple injections
20 patients
0.5mg/eye/time

Additional relevant MeSH terms:
Edema
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014