Colour Contrast Sensitivity for the Early Detection of Wet Age-related Macular Degereration (CEDAR)

NCT02173496 | Completed

• 2 other identifiers: CEDAR00114/WM/0035
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 1

Brief Summary

Neovascular or wet age-related macular degeneration (ARMD) is a retinal disease and is the leading cause of sight loss in the over 50s; it constitutes a major public health problem which will have an increasingly large impact as the population ages, because sight loss has been associated with loss of independence, depression, social isolation, and falls. Recent advances in medicine, and in particular the approval on behalf of the National Institute for Health and Clinical Excellence (NICE) for use of ranibizumab (Lucentis) in wet ARMD, have allowed this condition to be treated; however success is more likely when treatments occur at a very early stage. Unfortunately the early stages of wet ARMD do not cause symptoms and most cases are diagnosed when irreversible retinal damage has already occurred. In all stages of ARMD, even when no symptoms are present and non-invasive techniques currently used in routine clinical practice are not sufficiently sensitive to identify abnormalities, retinal function and possibly anatomy are abnormal. This study will evaluate techniques that may be useful in flagging subjects with the "preclinical" stages of the disease. This may allow early preventative measures to be taken, in order to stop altogether the onset of blindness. The study will focus mainly on colour contrast sensitivity, a simple but highly sensitive technique to assess retinal function, to establish if people with wet ARMD can be identified before symptoms develop. Other assessment modalities, evaluating either structure or function of the retina, will also be employed in selected individuals to establish if they may be used in the routine clinic; however it is already known that these modalities are not suitable for all individuals, as they are more demanding time-wise and concentration-wise, and therefore not universally suitable.

Conditions

Age Related Macular Degeneration

Keywords

Wet age-related macular degeneration; Assessment modalities for preclinical, pre-symptomatic ARMD

Outcome Measures

Primary Outcomes (1)

• Capability of evaluated techniques detecting asymptomatic wet ARMD

  24 months

Secondary Outcomes (1)

• Improve understanding of the disease process in wet ARMD

  24 months

Study Arms (1)

Colour contrast sensitivity

Colour contrast sensitivity

Other: Colour Contrast Sensitivity

Interventions

Colour Contrast Sensitivity OTHER

Reading of numbers or letters from a monitor

Colour contrast sensitivity

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unilateral wet ARMD

You may qualify if:

• Over 50 years of age
• Unilateral wet ARMD

You may not qualify if:

• Bilateral wet ARMD
• Other retinal pathology
• High refractive error
• Not fluent in English
• Unable to give informed consent

Sponsors & Collaborators

• Aston University: lead
• The Dunhill Medical Trust: collaborator

Study Sites (1)

Aston University

Birmingham, B4 7ET, United Kingdom

Location

Biospecimen

Retention: NONE RETAINED

Blood Samples

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Antonio Calcagni, MD

  Aston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: June 25, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)