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Age-related Macular DegenerationNCT00539734

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

A study testing ranibizumab in people with Age-related Macular Degeneration, run by Prince of Songkla University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Age-related Macular Degeneration
What is being tested?
ranibizumab
How many people
25 participants
Where
1 siteThailand
Study dates
Aug 2007to Feb 2009
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

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

    Hat Yai, Changwat Songkhla, 90110

Other trials in Thailand

About this study

Official title: Electrophysiologic Changes After Intravitreal Ranibizumab (Lucentis) 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.

Read the detailed description

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

Being tested
ranibizumab
Keywords
age-related macular degeneration (AMD), choroidal neovascularization membrane(CNVM), ranibizumab, anti-vascular endothelial growth factor, electrophysiology, electroretinography
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ranibizumabDrug

    Also called Lucentis

    A single dose of 0.5 mg ranibizumab injected intravitreally.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Height (Amplitude) of Multifocal ERG Signal

    Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data.

    Measured: baseline, 3 months

  2. 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.

    Measured: baseline, 3 months

Secondary outcomes (1)

  1. Postoperative Complication

    For instance, Endophthalmitis, retinal detachment

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionDec 2008
  4. Study completionFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00539734
Sponsor's protocol ID
50/362-003-2
Status last verified
Apr 2011
First submitted
2 Oct 2007
Last updated
15 Apr 2011
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17021318

  • 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.

    PubMed 17949673

Questions about this trial

What is this clinical trial studying?

A study testing ranibizumab in people with Age-related Macular Degeneration, run by Prince of Songkla University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Height (Amplitude) of Multifocal ERG Signal (time frame: baseline, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00539734, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2011.

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