Skip to main content
OpenTrials
Completed

NCT Number: NCT00539734

Changes in Retinal Function After Intravitreal Ranibizumab 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

A single dose of 0.5 mg ranibizumab injected intravitreally.

Other names: Lucentis

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Postoperative Complication

    Time frame: 1 month

    For instance, Endophthalmitis, retinal detachment

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Oct 4, 2007
Registry last updated
Apr 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.