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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02399072




Registration number
NCT02399072
Ethics application status
Date submitted
23/03/2015
Date registered
26/03/2015
Date last updated
9/08/2019

Titles & IDs
Public title
A Study of Disease Progression in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Scientific title
A Multicenter, Prospective Epidemiologic Study of the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration
Secondary ID [1] 0 0
2014-003940-11
Secondary ID [2] 0 0
GX29639
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No intervention

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 interventions: No intervention
No intervention administered in this study
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change from Baseline in the GA Area as Assessed by Fundus Autofluorescence (FAF) up to Month 60
Timepoint [1] 0 0
Baseline up to Month 60
Secondary outcome [1] 0 0
Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart up to Month 60
Timepoint [1] 0 0
Baseline up to Month 60
Secondary outcome [2] 0 0
Change from Baseline in BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions up to Month 60
Timepoint [2] 0 0
Baseline up to Month 60
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline up to Month 60
Secondary outcome [4] 0 0
Change from Baseline in Monocular Reading Speed as Assessed by MNRead Cards or Radner Reading Cards up to Month 60
Timepoint [4] 0 0
Baseline up to Month 60
Secondary outcome [5] 0 0
Change from Baseline in Binocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60
Timepoint [5] 0 0
Baseline up to Month 60
Secondary outcome [6] 0 0
Change from Baseline in Monocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60
Timepoint [6] 0 0
Baseline up to Month 60
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Baseline up to Month 60
Secondary outcome [8] 0 0
Change from Baseline in Distance Activity Subscale as Assessed by NEI VFQ-25 up to Month 60
Timepoint [8] 0 0
Baseline up to Month 60
Secondary outcome [9] 0 0
Change from Baseline in Composite Scores as Assessed by NEI VFQ-25 up to Month 60
Timepoint [9] 0 0
Baseline up to Month 60
Secondary outcome [10] 0 0
Change from Baseline in Functional Reading Independence Score up to Month 60
Timepoint [10] 0 0
Baseline up to Month 60
Secondary outcome [11] 0 0
Percentage of Participants With Medical Events
Timepoint [11] 0 0
Baseline up to Month 60
Secondary outcome [12] 0 0
Percentage of Participants With Ocular Events
Timepoint [12] 0 0
Baseline up to Month 60

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/02/2018
Sample size
Target
Accrual to date
Final
202
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Marsden Eye Research Centre - Parramatta
Recruitment hospital [2] 0 0
Adelaide Eye and Retina Centre - Adelaide
Recruitment hospital [3] 0 0
Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment hospital [4] 0 0
The Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2150 - Parramatta
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
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United States of America
State/province [2] 0 0
Missouri
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United States of America
State/province [3] 0 0
North Carolina
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United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
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United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
West Virginia
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Capital Federal
Country [11] 0 0
Argentina
State/province [11] 0 0
Cordoba
Country [12] 0 0
Argentina
State/province [12] 0 0
Mendoza
Country [13] 0 0
Brazil
State/province [13] 0 0
SP
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Nova Scotia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
France
State/province [18] 0 0
Creteil
Country [19] 0 0
France
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Dijon
Country [20] 0 0
France
State/province [20] 0 0
Lyon cedex
Country [21] 0 0
France
State/province [21] 0 0
Marseille
Country [22] 0 0
France
State/province [22] 0 0
Paris
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France
State/province [23] 0 0
Poitiers
Country [24] 0 0
France
State/province [24] 0 0
St Cyr Sur Loire
Country [25] 0 0
Germany
State/province [25] 0 0
Bonn
Country [26] 0 0
Germany
State/province [26] 0 0
Köln
Country [27] 0 0
Germany
State/province [27] 0 0
Münster
Country [28] 0 0
Germany
State/province [28] 0 0
Regensburg
Country [29] 0 0
Hungary
State/province [29] 0 0
Budapest
Country [30] 0 0
Hungary
State/province [30] 0 0
Debrecem
Country [31] 0 0
Hungary
State/province [31] 0 0
Pecs
Country [32] 0 0
Italy
State/province [32] 0 0
Lazio
Country [33] 0 0
Italy
State/province [33] 0 0
Lombardia
Country [34] 0 0
Poland
State/province [34] 0 0
Bydgoszcz
Country [35] 0 0
Poland
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Bytom
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Poland
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Gdansk
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Wroclaw
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Poland
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Lódz
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Spain
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Barcelona
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Spain
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Navarra
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Bradford
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Bristol
Country [45] 0 0
United Kingdom
State/province [45] 0 0
London
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Southhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02399072
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02399072