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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02479386




Registration number
NCT02479386
Ethics application status
Date submitted
19/06/2015
Date registered
24/06/2015
Date last updated
20/08/2019

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
2014-003939-19
Secondary ID [2] 0 0
GX29633
Universal Trial Number (UTN)
Trial acronym
Proxima A
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

Cohort Geographic Atrophy - Cohort of participants with GA secondary to AMD will be evaluated for changes in GA over time.


Other interventions: No intervention
No intervention was administered in this study.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Scotomatous Points as Assessed by Mesopic Microperimetry (MP)
Timepoint [1] 0 0
Baseline up to end of study (up to approximately 48 months)
Primary outcome [2] 0 0
Macular Sensitivity as Assessed by Mesopic MP
Timepoint [2] 0 0
Baseline up to end of study (up to approximately 48 months)
Primary outcome [3] 0 0
Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Timepoint [3] 0 0
Baseline up to end of study (up to approximately 48 months)
Primary outcome [4] 0 0
BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions
Timepoint [4] 0 0
Baseline up to end of study (up to approximately 48 months)
Primary outcome [5] 0 0
Monocular and Binocular Reading Speed as Assessed by the Minnesota Low-Vision Reading Test (MNRead) or by Radner Reading Cards
Timepoint [5] 0 0
Baseline up to end of study (up to approximately 48 months)
Primary outcome [6] 0 0
Monocular and Binocular Critical Print Size as Assessed by the MNRead or by Radner Reading Cards
Timepoint [6] 0 0
Baseline up to end of study (up to approximately 48 months)
Secondary outcome [1] 0 0
Change from Baseline in the GA area, as Assessed by Fundus Autofluorescence (FAF)
Timepoint [1] 0 0
Baseline, end of study (up to approximately 48 months)
Secondary outcome [2] 0 0
Change from Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Version (NEI VFQ-25) Score
Timepoint [2] 0 0
Baseline, end of study (up to approximately 48 months)
Secondary outcome [3] 0 0
Change from Baseline in Functional Reading Independence (FRI) Index Score
Timepoint [3] 0 0
Baseline, end of study (up to approximately 48 months)
Secondary outcome [4] 0 0
Percentage of Participants With Medical Events of Interest (MEIs) - The clinical events (cardiovascular, respiratory, cognitive, ocular events etc.) occurring during the study are termed as MEIs. These events will be collected using MEI electronic Case Report Form (eCRF) checklist.
Timepoint [4] 0 0
Baseline up to end of study (up to approximately 48 months)

Eligibility
Key inclusion criteria
- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods that result in a failure rate
of less than (<) 1 percent (%) per year for at least 30 days after the last
fluorescein dye administration

- The study is being conducted in participants with GA in both Study Eye and Non-Study
Eye (bilateral GA) with no evidence of prior or active choroidal neovascularization
(CNV)
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous participation in any studies of investigational drugs for GA or dry AMD
(except 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 or 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 in the study
Protocol

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Northern Beaches Retina Cataract Glaucoma - Mona Vale
Recruitment hospital [2] 0 0
Strathfield Retina Clinic - Strathfield
Recruitment hospital [3] 0 0
Newcastle Eye Hospital Research Foundation - Waratah
Recruitment hospital [4] 0 0
Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment hospital [5] 0 0
The Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2103 - Mona Vale
Recruitment postcode(s) [2] 0 0
2135 - Strathfield
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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California
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Colorado
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Florida
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Illinois
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Kentucky
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Maryland
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Michigan
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New York
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North Carolina
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Pennsylvania
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South Carolina
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Texas
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Virginia
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Argentina
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Buenos Aires
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Capital Federal
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Cordoba
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Mar del Plata
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Argentina
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Rosario
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Austria
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Wien
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Brazil
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GO
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Brazil
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MG
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SC
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Lille
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Lyon
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France
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Marseille
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France
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Paris Cedex 19
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France
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Paris
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France
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Poitiers
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France
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St Cyr Sur Loire
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France
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Strasbourg
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Germany
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Leipzig
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Germany
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München
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Germany
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Tuebingen
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Greece
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Heraklion
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Szombathely
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Rehovot
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Israel
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Tel Aviv
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Campania
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Lombardia
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Toscana
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Veneto
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Lublin
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Szczecin
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Wroclaw
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Barcelona
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Sevilla
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Valladolid
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United Kingdom
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Bristol
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Canterbury
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Hull
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Oxford
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Southhampton
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Sunderland
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United Kingdom
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Wakefield

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 is also intended to generate new information on the relationship between
genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study
enrolling 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 48 months. There is a planned
interim analysis around the 2-year time window for the study.
Trial website
https://clinicaltrials.gov/show/NCT02479386
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/show/NCT02479386