Macular Function During Anti-VEGF Treatment (MAFAT)

December 1, 2009 updated by: Royal Liverpool University Hospital

Study of Macular Function During Anti-VEGF Treatment

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

Study Overview

Status

Unknown

Conditions

Detailed Description

Macular function will be investigated using visual acuity, contrast sensitivity, mfERG and microperimetry.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Liverpool, United Kingdom, L7 8XP
        • Recruiting
        • Clinical Eye Research Centre
        • Contact:
        • Principal Investigator:
          • SIMON P HARDING, FRCOphth, MD
        • Sub-Investigator:
          • CLAUDIO S CAMPA, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

AMD clinic

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Group A
Patients investigated with mfERG and MP-1
Group B
Patients investigated by Laser Doppler Flowmetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mfERG central ring amplitude density
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean retinal sensitivity (dB) in three concentric rings (4°, 8° & 12°)
Time Frame: 12 months
12 months
Choroidal blood flow (ChBFlow) at fovea and at optic nerve head
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Liverpool University Hospital

Investigators

  • Principal Investigator: Simon P HARDING, FRCOphth, MD, University of Liverpool

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Estimate)

December 2, 2009

Last Update Submitted That Met QC Criteria

December 1, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Trust R&D_3704

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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