Changes in Retinal Function After Intravitreal Ranibizumab for Age-related Macular Degeneration

April 11, 2011 updated by: Prince of Songkla University

Electrophysiologic Changes After Intravitreal Ranibizumab (Lucentis) for Age-related Macular Degeneration

Age-related macular degeneration, a leading cause of blindness, is caused by an abnormal growth of the vessels beneath the retina. Ranibizumab (Lucentis) is a new drug that inhibits the growth of new vessels and has recently been approved by FDA for treating this condition. This study is carried out to evaluate the changes in retinal function after an injection of ranibizumab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The functional changes of the retina can be recorded by an electroretinography (ERG).

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

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

  • Thailand
    • Songkhla
      • Hat Yai, Songkhla, Thailand, 90110
        • Department of Ophthalmology, Faculty of Medicine, Prince of Songkla 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

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 45 years and above
  • Clinical diagnosis of wet AMD
  • First injection of ranibizumab protocol
  • Best corrected visual acuity 20/32 - 20/320
  • Consent form obtained

Exclusion Criteria:

  • Previously treated wet AMD patients
  • Patients with other ocular diseases which can cause abnormal ERG such as glaucoma, uveitis or retinitis pigmentosa, etc.
  • Pregnancy
  • History of seizure

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height (Amplitude) of Multifocal ERG Signal
Time Frame: baseline, 3 months
Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data.
baseline, 3 months
Time to Response (Implicit Time) of Multifocal ERG Signal
Time Frame: baseline, 3 months
Comparing the change in time of signal response (implicit time) at 3 months after treatment with baseline data.
baseline, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complication
Time Frame: 1 month
For instance, Endophthalmitis, retinal detachment
1 month

Collaborators and Investigators

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

Sponsor

Prince of Songkla University

Investigators

  • Principal Investigator: Patama Bhurayanontachai, MD, Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2007

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

October 2, 2007

First Submitted That Met QC Criteria

October 2, 2007

First Posted (ESTIMATE)

October 4, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2011

Last Update Submitted That Met QC Criteria

April 11, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50/362-003-2

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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