Back to resultsChanges in Retinal Function After Intravitreal Ranibizumab for Age-related Macular Degeneration
Primary Purpose
Age-related Macular Degeneration
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring age-related macular degeneration (AMD), choroidal neovascularization membrane(CNVM), ranibizumab, anti-vascular endothelial growth factor, electrophysiology, electroretinography
Eligibility 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
Sites / Locations
- Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University
Outcomes
Primary Outcome Measures
Height (Amplitude) of Multifocal ERG Signal
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
Comparing the change in time of signal response (implicit time) at 3 months after treatment with baseline data.
Secondary Outcome Measures
Postoperative Complication
For instance, Endophthalmitis, retinal detachment
Full Information
NCT ID
NCT00539734
First Posted
October 2, 2007
Last Updated
April 11, 2011
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT00539734
Brief Title
Changes in Retinal Function After Intravitreal Ranibizumab for Age-related Macular Degeneration
Official Title
Electrophysiologic Changes After Intravitreal Ranibizumab (Lucentis) for Age-related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Prince of Songkla University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
The functional changes of the retina can be recorded by an electroretinography (ERG).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration
Keywords
age-related macular degeneration (AMD), choroidal neovascularization membrane(CNVM), ranibizumab, anti-vascular endothelial growth factor, electrophysiology, electroretinography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
A single dose of 0.5 mg ranibizumab injected intravitreally.
Primary Outcome Measure Information:
Title
Height (Amplitude) of Multifocal ERG Signal
Description
Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data.
Time Frame
baseline, 3 months
Title
Time to Response (Implicit Time) of Multifocal ERG Signal
Description
Comparing the change in time of signal response (implicit time) at 3 months after treatment with baseline data.
Time Frame
baseline, 3 months
Secondary Outcome Measure Information:
Title
Postoperative Complication
Description
For instance, Endophthalmitis, retinal detachment
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patama Bhurayanontachai, MD
Organizational Affiliation
Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
17021318
Citation
Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.
Results Reference
background
PubMed Identifier
17949673
Citation
Kaiser PK, Brown DM, Zhang K, Hudson HL, Holz FG, Shapiro H, Schneider S, Acharya NR. Ranibizumab for predominantly classic neovascular age-related macular degeneration: subgroup analysis of first-year ANCHOR results. Am J Ophthalmol. 2007 Dec;144(6):850-857. doi: 10.1016/j.ajo.2007.08.012. Epub 2007 Oct 22.
Results Reference
background
Learn more about this trial
Changes in Retinal Function After Intravitreal Ranibizumab for Age-related Macular Degeneration
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