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

This study has been completed.
Sponsor:
Information provided by:
Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT00539734
First received: October 2, 2007
Last updated: April 11, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Age-related Macular Degeneration
 Drug: ranibizumab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Electrophysiologic Changes After Intravitreal Ranibizumab (Lucentis) for Age-related Macular Degeneration

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • Height (Amplitude) of Multifocal ERG Signal [ Time Frame: baseline, 3 months ] [ Designated as safety issue: Yes ]
    Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data.

  • Time to Response (Implicit Time) of Multifocal ERG Signal [ Time Frame: baseline, 3 months ] [ Designated as safety issue: Yes ]
    Comparing the change in time of signal response (implicit time) at 3 months after treatment with baseline data.


Secondary Outcome Measures:
  • Postoperative Complication [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    For instance, Endophthalmitis, retinal detachment


Enrollment: 25
Study Start Date: August 2007
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ranibizumab
    A single dose of 0.5 mg ranibizumab injected intravitreally.
    Other Name: Lucentis
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539734

Locations
Thailand
Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Patama Bhurayanontachai, MD Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University
  More Information

Publications:

Responsible Party: Dr.Patama Bhurayanontachai, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT00539734     History of Changes
Other Study ID Numbers: 50/362-003-2
Study First Received: October 2, 2007
Results First Received: February 8, 2011
Last Updated: April 11, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
age-related macular degeneration (AMD)
choroidal neovascularization membrane(CNVM)
ranibizumab
 anti-vascular endothelial growth factor
electrophysiology
electroretinography

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013