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

Not Applicable

Completed

• Conditions: Age-related Macular Degeneration

• Registration Number: NCT00539734
• Lead Sponsor: Prince of Songkla University

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).

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-10-02
• Study First Submitted QC: 2007-10-02
• Study First Posted: 2007-10-04
• Primary Completion: 2008-12
• Study Completion: 2009-02
• Results First Submitted: 2011-02-08
• Results First Submitted QC: 2011-03-07
• Status Verified: 2011-04
• Results First Posted: 2011-04-08
• Last Update Submitted: 2011-04-11
• Last Update Posted: 2011-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Height (Amplitude) of Multifocal ERG Signal	baseline, 3 months	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	baseline, 3 months	Comparing the change in time of signal response (implicit time) at 3 months after treatment with baseline data.

Secondary Outcome Measures

Name	Time	Method
Postoperative Complication	1 month	For instance, Endophthalmitis, retinal detachment

Trial Locations

Locations (1)

Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University; 🇹🇭 Hat Yai, Songkhla, Thailand