NCT01023971

Brief Summary

The purpose of this study is to determine the changes in macular function during anti-VEGF treatment for neovascular age-related macular degeneration.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
Last Updated

December 2, 2009

Status Verified

December 1, 2009

First QC Date

December 1, 2009

Last Update Submit

December 1, 2009

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • mfERG central ring amplitude density

    12 months

Secondary Outcomes (2)

  • Mean retinal sensitivity (dB) in three concentric rings (4°, 8° & 12°)

    12 months

  • Choroidal blood flow (ChBFlow) at fovea and at optic nerve head

    12 months

Study Arms (2)

Group A

Patients investigated with mfERG and MP-1

Group B

Patients investigated by Laser Doppler Flowmetry

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

AMD clinic

You may qualify if:

  • Neovascular AMD in first or second eyes
  • angiographic signs of active subfoveal or juxtafoveal choroidal neovascularization (CNV)
  • BCVA ≥35 ETDRS letters

You may not qualify if:

  • Spherical equivalent ≥ ± 6 D
  • Previous treatments for CNV in the studied eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Eye Research Centre

Liverpool, L7 8XP, United Kingdom

RECRUITING

Related Publications (1)

  • Campa C, Hagan R, Sahni JN, Brown MC, Beare NA, Heimann H, Harding SP. Early multifocal electroretinogram findings during intravitreal ranibizumab treatment for neovascular age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Jun 1;52(6):3446-51. doi: 10.1167/iovs.10-6588.

    PMID: 21357390DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Simon P HARDING, FRCOphth, MD

    University of Liverpool

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon P Harding, FRCOphth, MD

CONTACT

+44 0151 706S.P.Harding@liverpool.ac.uk

Claudio S Campa, MD, PhD

CONTACT

+44 0151 706Claudio.Campa@rlbuht.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 1, 2009

First Posted

December 2, 2009

Study Start

January 1, 2009

Last Updated

December 2, 2009

Record last verified: 2009-12

Locations

GB(1)