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)

July 21, 2014 updated by: Chengdu Kanghong Biotech Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou city, Guangdong, China
        • Zhongshan Ophthalmic Center,Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conbercept
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.
Drug: Conbercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of patients with best corrected visual acuity (BCVA ) ≥19 letters gain
Time Frame: 6-month
6-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean change in BCVA from baseline
Time Frame: 6-month
6-month
change from baseline of macular area thickness and other anatomy results
Time Frame: 6-month
6-month
safety of Conbercept therapy
Time Frame: 6-month
To assess incidence of adverse events, incidence of adverse drug reactions etc.
6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Kanghong Biotech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 25, 2014

First Submitted That Met QC Criteria

March 27, 2014

First Posted (Estimate)

March 28, 2014

Study Record Updates

Last Update Posted (Estimate)

July 22, 2014

Last Update Submitted That Met QC Criteria

July 21, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHSWKH902009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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