NCT01242254

Brief Summary

This study is designed to assess the efficacy and safety of multiple intravitreal injection of KH902 in patients with CNV due to AMD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 27, 2014

Status Verified

July 1, 2011

Enrollment Period

7 months

First QC Date

November 10, 2010

Last Update Submit

March 25, 2014

Conditions

Neovascular Age-related Macular Degeneration

Keywords

KH902age-related macular degenerationchoroidal neovascularizationintravitreal injectionmultiple injections

Outcome Measures

Primary Outcomes (1)

  • The incidence rate of adverse event

    To evaluate the safety of multiple intravitreal injection of KH902 of each group.

    at 52 week

Secondary Outcomes (1)

  • Change from Baseline in BCVA

    Specified timepoints during the screening phase and 52-week treatment period

Study Arms (2)

Group A

EXPERIMENTAL

Patients will receive an intravitreal injection of KH902 0.5mg/eye/time monthly, after 3-time treatment patients will go on an as needed (PRN) dosing phase till week 52

Biological: Intravitreal injection of KH902

Group B

EXPERIMENTAL

Patients will receive an intravitreal injection of KH902 2.0mg/eye/time monthly, after 3-time treatment patients will go on an as needed (PRN) dosing phase till week 52

Biological: Intravitreal injection of KH902

Interventions

Intravitreal injection of KH902BIOLOGICAL

0.5 mg 2.0 mg once per 4 weeks during fixed dosing phase once as needed during extended treatment phase

Group AGroup B

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed the Informed Consent Form by patients or legal representative;
  • Men and women ≥ 45 years of age;
  • Active primary or recurrent lesions with CNV secondary to neovascular AMD;
  • Total lesion size ≤ 12 disc areas in either eye;
  • BCVA of the study eyes \< 69 letters and the BCVA of fellow eyes ≥ 19 letters;
  • Clear ocular media and adequate pupil dilation.

You may not qualify if:

  • CNV lesion secondary to ocular conditions other than neovascular AMD
  • History of vitreous hemorrhage, retinal tear, rhegmatogenous retinal detachment or macular hole in the study eye;
  • Presence of retinal detachment, retinal pigment epithelial tear, or retinal macular traction in the study eye;
  • Anaphylactic disease;
  • Uncontrolled glaucoma in either eye;
  • Current active ocular inflammation or infection in either eye;
  • Previous anti-VEGF drug treatment in the study eye within three months preceding screening, and/or, for the fellow eye, within one month preceding screening;
  • Previous ophthalmologic operation or laser therapy in the study eye within three months preceding screening;
  • Current non-healing wound, ulcer, fractures, etc;
  • Uncontrolled systemic conditions;
  • Patients of child-bearing potential do not adopted adequate contraception methods;
  • Pregnant or nursing women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100000, China

Location

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

West China Hospital ,Sichuan University

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Macular DegenerationChoroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Junjun Zhang

    West China Hospital

    PRINCIPAL INVESTIGATOR

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

November 10, 2010

First Posted

November 16, 2010

Study Start

August 1, 2009

Primary Completion

March 1, 2010

Study Completion

February 1, 2011

Last Updated

March 27, 2014

Record last verified: 2011-07

Locations

CN(3)