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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

October 2, 2007
April 11, 2011
August 2007
December 2008   (final data collection date for primary outcome measure)
  • 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.
Electrophysiologic changes after the treatment [ Time Frame: baseline, 2 weeks, 1 month ]
Complete list of historical versions of study NCT00539734 on ClinicalTrials.gov Archive Site
Postoperative Complication [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
For instance, Endophthalmitis, retinal detachment
Not Provided
Not Provided
Not Provided
 
Changes in Retinal Function After Intravitreal Ranibizumab for Age-related Macular Degeneration
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.

The functional changes of the retina can be recorded by an electroretinography (ERG).
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Age-related Macular Degeneration
Drug: ranibizumab
A single dose of 0.5 mg ranibizumab injected intravitreally.
Other Name: Lucentis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00539734
50/362-003-2
Yes
Dr.Patama Bhurayanontachai, Prince of Songkla University
Prince of Songkla University
Not Provided
Principal Investigator: Patama Bhurayanontachai, MD Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University
Prince of Songkla University
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP