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A Study of Disease Progression in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02399072
First received: March 23, 2015
Last updated: June 21, 2017
Last verified: June 2017
  Purpose
This study seeks to better characterize relationships between visual function and the progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration (AMD). The study also will generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling 200 participants with GA secondary to AMD. The study visits are scheduled to occur every 6 months. The anticipated duration of the study is up to 60 months.

Condition Intervention
Geographic Atrophy Other: No intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multicenter, Prospective Epidemiologic Study of the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean Change from Baseline in the GA Area as Assessed by Fundus Autofluorescence (FAF) up to Month 60 [ Time Frame: Baseline up to Month 60 ]

Secondary Outcome Measures:
  • Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart up to Month 60 [ Time Frame: Baseline up to Month 60 ]
  • Change from Baseline in BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions up to Month 60 [ Time Frame: Baseline up to Month 60 ]
  • Change from Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Cards or Radner Reading Cards up to Month 60 [ Time Frame: Baseline up to Month 60 ]
  • Change from Baseline in Monocular Reading Speed as Assessed by MNRead Cards or Radner Reading Cards up to Month 60 [ Time Frame: Baseline up to Month 60 ]
  • Change from Baseline in Binocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60 [ Time Frame: Baseline up to Month 60 ]
  • Change from Baseline in Monocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60 [ Time Frame: Baseline up to Month 60 ]
  • Change from Baseline in Near Activity Subscale as Assessed by National Eye Institute Visual Functioning Questionnaire 25-Item Version (NEI VFQ-25) up to Month 60 [ Time Frame: Baseline up to Month 60 ]
  • Change from Baseline in Distance Activity Subscale as Assessed by NEI VFQ-25 up to Month 60 [ Time Frame: Baseline up to Month 60 ]
  • Change from Baseline in Composite Scores as Assessed by NEI VFQ-25 up to Month 60 [ Time Frame: Baseline up to Month 60 ]
  • Change from Baseline in Functional Reading Independence Score up to Month 60 [ Time Frame: Baseline up to Month 60 ]
  • Percentage of Participants With Medical Events [ Time Frame: Baseline up to Month 60 ]
  • Percentage of Participants With Ocular Events [ Time Frame: Baseline up to Month 60 ]

Estimated Enrollment: 200
Actual Study Start Date: March 30, 2015
Estimated Study Completion Date: June 1, 2022
Estimated Primary Completion Date: June 1, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Geographic Atrophy Participants
Participants with unilateral GA or GA in one eye and choroidal neovascularization (CNV; active or treated) with or without GA, in the contralateral eye, will be evaluated for the progression of GA for up to approximately 60 months.
Other: No intervention
No intervention administered in this study

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Well-demarcated area of GA secondary to AMD
  • Women of childbearing potential and men must agree to use adequate contraception for at least 30 days after fluorescein dye administration
  • The study is recruiting participants in two different cohorts:

Cohort 1: Participants with unilateral GA OR Cohort 2: Participants with GA in one eye and CNV (active or treated) with or without GA, in the contralateral eye

Exclusion Criteria:

  • Previous participation in any studies of investigational drugs for GA / dry AMD (exception for studies of vitamins and minerals)
  • GA in either eye due to causes other than AMD
  • History of vitrectomy surgery, submacular surgery, or any surgical intervention for AMD
  • Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and/or proliferative diabetic retinopathy
  • Any ocular/systemic medical conditions that, in the opinion of the investigator, could contribute to participant's inability to participate in the study or interfere with study assessments.
  • Requirement for continuous use of therapy indicated in Prohibited Therapy
  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: NCT02399072

  Show 63 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02399072     History of Changes
Other Study ID Numbers: GX29639
2014-003940-11 ( EudraCT Number )
GX29639 ( Other Identifier: Hoffmann-La Roche ID )
Study First Received: March 23, 2015
Last Updated: June 21, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 17, 2017