Visual Function Tests in Age-related Macular Degeneration

NCT ID: NCT03275753

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-21
• Study Completion Date: 2022-12-31

Brief Summary

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

Detailed Description

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.

Conditions

Age Related Macular Degeneration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Normal Population

VA of 20/25 or better in the study eye with no prior diagnosis of any retinal or ocular diseases

Visual Function Tests

Intervention Type: OTHER

All subjects will undergo a battery of visual function tests

Early Dry AMD Population

VA of 20/40 or better in the study eye with clinical diagnosis of early dry AMD

Visual Function Tests

Intervention Type: OTHER

All subjects will undergo a battery of visual function tests

Intermediate Dry AMD Population

VA of 20/40 or better in the study eye with clinical diagnosis of intermediate dry AMD

Visual Function Tests

Intervention Type: OTHER

All subjects will undergo a battery of visual function tests

Advanced Dry AMD Population

Clinical diagnosis of advanced dry AMD in the study eye

Visual Function Tests

Intervention Type: OTHER

All subjects will undergo a battery of visual function tests

Interventions

Visual Function Tests

All subjects will undergo a battery of visual function tests

Intervention Type: OTHER

Eligibility Criteria

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

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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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ORA, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Chin, OD

Role: PRINCIPAL_INVESTIGATOR

ORA, Inc.

Locations

Andover Eye Associates

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

17-270-0001

Identifier Type: -

Identifier Source: org_study_id