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

August 7, 2019 updated by: Hoffmann-La Roche

A Multicenter, Prospective Epidemiologic Study of the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1015ABO
        • Organización Médica de Investigación
      • Capital Federal, Argentina, C1120AAN
        • Oftalmos
      • Cordoba, Argentina
        • Centro Privado de Ojos Romagosa
      • Cordoba, Argentina
        • Onnis Instituto oftalmológico privado
      • Mendoza, Argentina, M5500GGK
        • Oftar
  • Australia
    • New South Wales
      • Parramatta, New South Wales, Australia, 2150
        • Marsden Eye Research Centre
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Adelaide Eye and Retina Centre
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Royal Victorian Eye and Ear Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • The Lions Eye Institute
  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04038-032
        • Instituto da Visao IPEPO
      • Sao Paulo, SP, Brazil, 05403-000
        • Hosp Clinicas da FMUSP
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z4
        • University of British Columbia
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII - HSC Department of Ophthalmology
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5T 2S8
        • University Health Network Toronto Western Hospital
    • Quebec
      • Boisbriand, Quebec, Canada, J7H 1S6
        • Institut De L'Oeil Des Laurentides
      • Montreal, Quebec, Canada, H1T 2M4
        • Hôpital Maisonneuve - Rosemont
  • France
      • Creteil, France, 94010
        • Chi De Creteil; Ophtalmologie
      • Dijon, France, 21079
        • CHU Bocage; Ophtalmologie
      • Lyon cedex, France, 69317
        • Hopital de la croix rousse; Ophtalmologie
      • Marseille, France, 13008
        • Centre Paradis Monticelli; Ophtalmologie
      • Paris, France, 75006
        • Centre Odeon; Exploration Ophtalmologique
      • Paris, France, 75010
        • Hopital Lariboisiere; Ophtalmologie
      • Paris, France, 75012
        • CHNO des Quinze Vingts; Ophtalmologie
      • Poitiers, France, 86021
        • CHU Poitiers - CHR La Miletrie; Ophtalmologie
      • St Cyr Sur Loire, France, 37540
        • Centres Ophtalmologique St Exupéry; Ophtalmologie
  • Germany
      • Bonn, Germany, 53127
        • Universitäts-Augenklinik Bonn
      • Köln, Germany, 50937
        • Universitätsklinikum Köln; Augenklinik
      • Münster, Germany, 48149
        • Universitätsklinikum Münster; Augenheilkunde
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
  • Hungary
      • Budapest, Hungary, 1133
        • Budapest Retina Associates Kft.
      • Budapest, Hungary, 1076
        • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem AOK, Szemeszeti Klinika
      • Debrecem, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
      • Pecs, Hungary, 7621
        • Ganglion Medial Center
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00133
        • Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
    • Lombardia
      • Milano, Lombardia, Italy, 20157
        • ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
  • Poland
      • Bydgoszcz, Poland, 85-631
        • OFTALMIKA Sp. z o.o
      • Bytom, Poland, 41-902
        • Szpital Specjalistyczny nr 1; Oddzial Okulistyki
      • Gdańsk, Poland, 80-809
        • Optimum Profesorskie Centrum Okulistyki
      • Katowice, Poland, 40-594
        • Gabinet Okulistyczny Prof Edward Wylegala
      • Krakow, Poland, 31-501
        • SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
      • Wroclaw, Poland, 53-334
        • SPEKTRUM Osrodek Okulistyki Klinicznej
      • Łódź, Poland, 91-134
        • Klinika Okulistyczna Jasne Błonia
  • Spain
      • Barcelona, Spain, 08022
        • Institut de la Macula i la retina
    • Barcelona
      • Hospitalet De Llobregat, Barcelona, Spain, 8907
        • Hospital Universitari de Bellvitge; Servicio de Oftalmologia
      • San Cugat Del Valles, Barcelona, Spain, 08195
        • Hospital General de Catalunya
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra; Servicio de Oftalmologia
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Bristol, United Kingdom, BS1 2LX
        • Bristol Eye Hospital
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust
      • Southhampton, United Kingdom, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
  • United States
    • Florida
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Midwest Vision Research Foundation
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Char Eye Ear &Throat Assoc
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Retina Assoc of Cleveland Inc
    • South Carolina
      • Florence, South Carolina, United States, 29501
        • Palmetto Retina Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina PC.
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Res Institute of Texas
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Houston
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research Group, LLC
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Baseline up to Month 60

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
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
Baseline up to Month 60
Change from Baseline in Functional Reading Independence Score up to Month 60
Time Frame: Baseline up to Month 60
Baseline up to Month 60
Percentage of Participants With Medical Events
Time Frame: Baseline up to Month 60
Baseline up to Month 60
Percentage of Participants With Ocular Events
Time Frame: Baseline up to Month 60
Baseline up to Month 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 8, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GX29639 (Other Identifier: Hoffmann-La Roche ID)
  • 2014-003940-11 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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