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

Age-related Macular Degeneration Clinical Trial

Official title:

Electrophysiologic Changes After Intravitreal Ranibizumab (Lucentis) for Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539734
• Other study ID #: 50/362-003-2
• Status: Completed
• Phase: N/A
• First received: October 2, 2007
• Last updated: April 11, 2011
• Start date: August 2007
• Est. completion date: February 2009

Study information

• Verified date: April 2011
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• ranibizumab
A single dose of 0.5 mg ranibizumab injected intravitreally.

Locations

Country	Name	City	State
Thailand	Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

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. Epub 2007 Oct 22. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height (Amplitude) of Multifocal ERG Signal	Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data.	baseline, 3 months	Yes
Primary	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.	baseline, 3 months	Yes
Secondary	Postoperative Complication	For instance, Endophthalmitis, retinal detachment	1 month	Yes