Visual Function Tests in Age-related Macular Degeneration



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:60 - 99
Updated:11/1/2018
Start Date:September 21, 2017
End Date:December 2019
Contact:Divya Narayanan, PhD
Email:dnarayanan@oraclinical.com
Phone:9786858900

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Visual Function Tests in Non-Exudative Age-Related Macular Degeneration and Normal Subjects

The goal of this study is to assess a battery of visual function tests in subjects with
non-exudative age-related macular degeneration

Age-related macular degeneration (AMD) is one of the leading causes of visual impairment
among elderly populations in developed countries. Majority of AMD patients (80%) suffer from
the dry or non-exudative form of the disease. Currently there are no approved treatments for
dry AMD. Clinical development of therapeutic agents for dry AMD is limited by slow
progressing nature of the disease as well as the lack of sensitive endpoints to assess
therapeutic efficacy. Visual acuity, the commonly used functional endpoint, remains minimally
affected during early stages of dry AMD. Thus novel visual function endpoints, that can
identify functional deficits during early stages of dry AMD prior to development of
geographic atrophy, are needed. In the current study a battery of visual function tests will
be evaluated in subjects with different stages of dry AMD and normal controls, to assess
their sensitivity and feasibility as potential functional endpoints for dry AMD.

Inclusion Criteria:

- All Subjects Must:

1. Be 60 years of age or older;

2. Provide written informed consent;

3. Be willing and able to follow all instructions and attend the study visits;

4. Must be able to perform all study procedures;

Normal Subjects:

5. Have BCVA of 20/25 or better in the study eye;

6. Have no history or clinical evidence of AMD, retinal diseases or any other ocular
pathologies in either eye;

AMD Subjects:

7. Have BCVA of 20/40 or better in the study eye;

8. Have a clinical diagnosis of non-exudative AMD in the study eye;

Exclusion Criteria:

All subjects must not have any of the below criteria

1. Have a diagnosis of wet AMD in the study eye;

2. Have any other hereditary or acquired retinal diseases in either eye ;

3. Have glaucoma or other optic nerve diseases in either eye;

4. Have corneal or other anterior segment diseases in either eye;

5. Have significant cataract in the study eye;

6. Have a history of ocular trauma or ocular surgery (other than cataract removal)
in the study eye;

7. Have a history of uncontrolled systemic disease (e.g. poorly controlled
hypertension or poorly controlled diabetes);

8. Have a history of seizures;

9. On psychotropic medications;

10. Any other symptoms or conditions that could, in the opinion of the investigator,
interfere with study procedures.
We found this trial at
1
site
Andover, Massachusetts 01810
Principal Investigator: Jason Chin, OD
?
mi
from
Andover, MA
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