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An Open, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration (wAMD) (LAMP)

Primary Purpose

Very Low Vision Secondary to Wet Age-related Macular Degeneration

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Conbercept
Sponsored by
Chengdu Kanghong Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Very Low Vision Secondary to Wet Age-related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients give fully informed consent and are willing and able to comply with all study procedures.

  2. In the study eye:

    There are primary or recurrent subfoveal or parafoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.

    The criterion of active CNV should meet at least one of following three conditions :

    • fresh bleeding;
    • neurosensory detachment showed on optical coherence tomography(OCT);
    • leakage showed on fundus fluorescein angiography (FFA).
  3. BCVA in study eye < 19 letters (approximately 20/400 Snellen equivalent).

Exclusion Criteria:

  1. Past or existing non-exudative AMD in study eye decided by investigator that have affected macular detection or central vision;
  2. Subretinal hemorrhage in study eye and bleeding area ≥6 disc areas;
  3. History of vitreous hemorrhage within last month;
  4. The maximum diameter of scar and fibrosis area ≥500μm at subfoveal in study eye;
  5. Photodynamic therapy (PDT) or drug treatment of CNV within last 6 months in study eye, or anti-vascular endothelial growth factor (VEGF) therapy in fellow eye within last month;
  6. History of glaucoma in study eye;
  7. Aphakia (excluding artificial lens) in the study eye.

Sites / Locations

  • Zhongshan Ophthalmic Center,Sun yat-sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Conbercept

Arm Description

Subjects will receive Conbercept injections at a dose of 0.5 mg/eye, once a month for first 3 months. In the next 3 months, the investigator will decide whether repeat injections are needed based on the monthly assessment results.

Outcomes

Primary Outcome Measures

percentage of patients with best corrected visual acuity (BCVA ) ≥19 letters gain

Secondary Outcome Measures

mean change in BCVA from baseline
change from baseline of macular area thickness and other anatomy results
safety of Conbercept therapy
To assess incidence of adverse events, incidence of adverse drug reactions etc.

Full Information

First Posted
March 25, 2014
Last Updated
July 21, 2014
Sponsor
Chengdu Kanghong Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02098720
Brief Title
An Open, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration (wAMD)
Acronym
LAMP
Official Title
An Open, Non-randomize, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu Kanghong Biotech Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to evaluate the effect of Conbercept therapy on visual acuity and anatomic outcomes and safety observed in subjects with very low vision secondary to wet age-related macular degeneration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Very Low Vision Secondary to Wet Age-related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conbercept
Arm Type
Experimental
Arm Description
Subjects will receive Conbercept injections at a dose of 0.5 mg/eye, once a month for first 3 months. In the next 3 months, the investigator will decide whether repeat injections are needed based on the monthly assessment results.
Intervention Type
Drug
Intervention Name(s)
Conbercept
Primary Outcome Measure Information:
Title
percentage of patients with best corrected visual acuity (BCVA ) ≥19 letters gain
Time Frame
6-month
Secondary Outcome Measure Information:
Title
mean change in BCVA from baseline
Time Frame
6-month
Title
change from baseline of macular area thickness and other anatomy results
Time Frame
6-month
Title
safety of Conbercept therapy
Description
To assess incidence of adverse events, incidence of adverse drug reactions etc.
Time Frame
6-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients give fully informed consent and are willing and able to comply with all study procedures. In the study eye: There are primary or recurrent subfoveal or parafoveal active choroidal neovascularization (CNV) lesions secondary to wAMD. The criterion of active CNV should meet at least one of following three conditions : fresh bleeding; neurosensory detachment showed on optical coherence tomography(OCT); leakage showed on fundus fluorescein angiography (FFA). BCVA in study eye < 19 letters (approximately 20/400 Snellen equivalent). Exclusion Criteria: Past or existing non-exudative AMD in study eye decided by investigator that have affected macular detection or central vision; Subretinal hemorrhage in study eye and bleeding area ≥6 disc areas; History of vitreous hemorrhage within last month; The maximum diameter of scar and fibrosis area ≥500μm at subfoveal in study eye; Photodynamic therapy (PDT) or drug treatment of CNV within last 6 months in study eye, or anti-vascular endothelial growth factor (VEGF) therapy in fellow eye within last month; History of glaucoma in study eye; Aphakia (excluding artificial lens) in the study eye.
Facility Information:
Facility Name
Zhongshan Ophthalmic Center,Sun yat-sen University
City
Guangzhou city
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Learn more about this trial

An Open, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration (wAMD)

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