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

NCT01324869 | Completed Phase 1

• 1 other identifier: KHSWKH902002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Macular Edema

Keywords

KH902; Diabetic macular Edema; Intravitreal injection; Multiple injections; 20 patients; 0.5mg/eye/time

Outcome Measures

Primary Outcomes (1)

• Incidence rate of adverse event

  To evaluate the safety of multiple intravitreal injection of KH902 to treat DME.

  up to 12 months

Secondary Outcomes (1)

• Change from Baseline in BCVA

  at the end of month 3 and the end of month 12

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Interventions

KH902 BIOLOGICAL

Intravitreal injection of 0.5mg/eye/time KH902

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed the Informed Consent Form and willing to comply with study procedures;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chengdu Kanghong Biotech Co., Ltd.: lead
• University of Wisconsin, Madison: collaborator
• Teaching and Research Office of Health Statistics, Fourth Military Medical University: collaborator

Study Sites (1)

Shanghai First People's Hospital

Shanghai, 200125, China

Location

Study Officials

• Xun Xu

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Lun De Luo

  Chengdu Kanghong Biotech Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 29, 2011
• Study Start: April 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 1, 2013

Record last verified: 2013-02

Locations

CN (1)