NCT00539734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

April 8, 2011

Completed
Last Updated

April 15, 2011

Status Verified

April 1, 2011

Enrollment Period

1.3 years

First QC Date

October 2, 2007

Results QC Date

February 8, 2011

Last Update Submit

April 11, 2011

Conditions

Age-related Macular Degeneration

Keywords

age-related macular degeneration (AMD)choroidal neovascularization membrane(CNVM)ranibizumabanti-vascular endothelial growth factorelectrophysiologyelectroretinography

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • Postoperative Complication

    1 month

Interventions

ranibizumabDRUG

A single dose of 0.5 mg ranibizumab injected intravitreally.

Also known as: Lucentis

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 17021318BACKGROUND

  • 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.

    PMID: 17949673BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Limitations and Caveats

Small number of participants

Results Point of Contact

Title
Patama Bhurayanontachai
Organization
Prince of Songkla University
tpatama@hotmail.com
66-74-451380

Study Officials

  • Patama Bhurayanontachai, MD

    Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 2, 2007

First Posted

October 4, 2007

Study Start

August 1, 2007

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

April 15, 2011

Results First Posted

April 8, 2011

Record last verified: 2011-04

Locations

TH(1)