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Study on Visual Function Impairments in Dry Age-related Macular Degeneration

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Duke University
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01822873
First received: March 28, 2013
Last updated: October 1, 2014
Last verified: September 2014
  Purpose

The study hypothesis is that patients with dry age-related macular degeneration experience visual function impairments such as defects in dark adaptation, glare intolerance, poor light transition and reading in low lighting conditions. Studies have shown that patients in the early phases of AMD with normal visual acuity commonly reported difficulty with these visual functions but there have been no systematic studies evaluating these deficits in this population.

This prospective, exploratory study will include up to 130 patients with dry AMD and 60 controls. These patients will undergo the following non-invasive visual function testing:

  • microperimetry with eye tracking
  • low luminance visual acuity
  • specialized color vision (cone-specific)
  • contrast testing and night vision testing.

High-resolution spectral domain optical coherence tomography (SDOCT) images will be taken of the central retina using the Spectralis OCT unit. The values of visual function tested will be correlated with the findings on SDOCT (volume/amount of drusen present in early AMD).

There are no known risks to the subjects beyond what is normal for standard examinations of the eye, visual function testing and standard ocular photographic procedures.


Condition
Age Related Macular Degeneration

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Visual Function Impairments in Patients With Early Dry Age-related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in low luminance visual acuity [ Time Frame: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in cone specific contrast sensitivity [ Time Frame: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Change in contrast sensitivity [ Time Frame: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Change in macular sensitivity on microperimetry [ Time Frame: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: March 2013
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal
Age-related macular degeneration

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be identified from patients of the Duke Eye Center presenting for ophthalmologic consultation. Patients with dry AMD are routinely available from this clinic and will be the primary study group.

Criteria

Inclusion Criteria:

  1. Capable and willing to provide consent
  2. Has been diagnosed with dry age-related macular degeneration stages 1-3
  3. At least 50 years of age

Exclusion Criteria:

  1. Unable or unwilling to give consent
  2. Under 50 years of age
  3. Presence of retinal pathology such as central geographic atrophy, hemorrhage or retinal fluid, and other macular pathology other than AMD
  4. Presence of dense cataracts in the study eye(s) that can affect visual function tests
  5. Presence of glaucoma requiring treatment during the study and/or visual field defects
  6. Presence retinal laser or surgical theraphy in study eye (s)
  7. Any of other ocular condition requiring long-term theraphy or surgery during the study
  8. Participant has photographically significant corneal or media opacities in either eye that would preclude adequate ophthalmic imaging and functional testing
  9. Diagnosis of nystagmus that will interfere with testing
  10. High myopia -8 Diopters or more severe
  11. Participant has, in the opinion of the Investigator, any physical or mental condition that would increase the risk of participation in the stduy or may interfere with the study procedures, evaluations and outcome assessments.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822873

Locations
United States, North Carolina
Duke Eye Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Eleonora Lad, MD, PhD    919-684-9010      
Principal Investigator: Eleonora Lad, MD, PhD         
Sponsors and Collaborators
Duke University
Hoffmann-La Roche
Investigators
Principal Investigator: Eleonora Lad, MD, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01822873     History of Changes
Other Study ID Numbers: Pro00036248
Study First Received: March 28, 2013
Last Updated: October 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014