Clinical trial NCT03275753: Visual Function Tests in Age-related Macular Degeneration
Official title: Visual Function Tests in Non-Exudative Age-Related Macular Degeneration and Normal Subjects
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Age Related Macular Degeneration
Keywords: Visual function
Critical flicker fusion
Dark adaptation
Reading test
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-08
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1: Normal Population (N=50) VA of 20/25 or better in the study eye with no prior diagnosis of any retinal or ocular diseases.

Group 2: Early Dry AMD Population (N=50) VA of 20/40 or better in the study eye with clinical diagnosis of early dry AMD based on fundus features.

Group 3: Intermediate Dry AMD Population (N=50) VA of 20/40 or better in the study eye with clinical diagnosis of intermediate dry AMD based on fundus features.

Group 4: Advanced Dry AMD Population (N=50) Clinical diagnosis of advanced dry AMD based on fundus features in the study eye

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.

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.

Primary outcomes:
measure: Critical flicker fusion
timeFrame: At study visit through study completion, an average of 2 years
Secondary outcomes:
measure: Dark adaptation
timeFrame: At study visit through study completion, an average of 2 years
measure: Reading Tests
timeFrame: At study visit through study completion, an average of 2 years
measure: Color vision function
timeFrame: At study visit through study completion, an average of 2 years
measure: Shape discrimination
timeFrame: At study visit through study completion, an average of 2 years
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: ORA, Inc.
name: Jason Chin, OD
role: PRINCIPAL_INVESTIGATOR
References: