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Trial record 1 of 1 for:    A MULTICENTER, PROSPECTIVE EPIDEMIOLOGIC STUDY OF THE PROGRESSION OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION
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An Epidemiologic Study of Disease Progression in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (Proxima B)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02399072
First received: March 23, 2015
Last updated: May 9, 2017
Last verified: May 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 patients 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: No masking
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:
  • Change in the GA area, as assessed by retinal imaging [ Time Frame: From Baseline over time(every 6 months) to end of study, up to 60 months ]

Secondary Outcome Measures:
  • Change in additional measures of visual function [ Time Frame: From Baseline over time (every 6 months) to end of study, up to 60 months ]
  • Best Corrected Visual Acuity (BCVA) score as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) chart under low luminance conditions [ Time Frame: From Baseline over time (every 6 months) to end of study, up to 60 months ]

Estimated Enrollment: 200
Actual Study Start Date: March 31, 2015
Estimated Study Completion Date: May 31, 2022
Estimated Primary Completion Date: May 31, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cohort Geographic Atrophy
Cohort of participants with geographic atrophy secondary to age−related macular degeneration will be evaluated for the progression of geographic atrophy.
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:

  • Age > or= 50 years, with well-demarcated area of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
  • The study is recruiting patients in two different cohorts:

Cohort 1: Patients with unilateral geographic atrophy OR Cohort 2: Patients with GA in one eye and choroidal neovascularization (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
  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

Contacts
Contact: Reference Study ID Number: GX29639 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

  Show 65 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 )
GX29633 ( Other Identifier: Hoffmann-La Roche ID )
Study First Received: March 23, 2015
Last Updated: May 9, 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 May 22, 2017