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.
|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|
- 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.
- Postoperative Complication [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]For instance, Endophthalmitis, retinal detachment
|Study Start Date:||August 2007|
|Study Completion Date:||February 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
The functional changes of the retina can be recorded by an electroretinography (ERG).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539734
|Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University|
|Hat Yai, Songkhla, Thailand, 90110|
|Principal Investigator:||Patama Bhurayanontachai, MD||Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University|