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

August 16, 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 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.

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.
296

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
      • Mar del Plata, Argentina, B7600DFC
        • Clinica Privada de Ojos
      • Rosario, Argentina, S2000ANJ
        • Centro Oftalmólogos Especialistas
  • Australia
    • New South Wales
      • Mona Vale, New South Wales, Australia, 2103
        • Northern Beaches Retina Cataract Glaucoma
      • Strathfield, New South Wales, Australia, 2135
        • Strathfield Retina Clinic
      • Waratah, New South Wales, Australia, 2298
        • Newcastle Eye Hospital Research Foundation
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Royal Victorian Eye and Ear Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • The Lions Eye Institute
  • Austria
      • Wien, Austria, 1090
        • Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
  • Brazil
    • GO
      • Aparecida de Goiania, GO, Brazil, 74980-010
        • Hospital de Olhos de Aparecida - HOA
    • MG
      • Belo Horizonte, MG, Brazil, 30150-270
        • Instituto da Visão
    • SC
      • Blumenau, SC, Brazil, 89052-504
        • Botelho Hospital da Visao
    • SP
      • Sao Paulo, SP, Brazil, 04038-032
        • Instituto da Visao IPEPO
      • Sao Paulo, SP, Brazil, 05403-000
        • Hosp Clinicas da FMUSP
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J 0C8
        • Calgary Retina Consultants
    • Quebec
      • Boisbriand, Quebec, Canada, J7H 1S6
        • Institut De L'Oeil Des Laurentides
  • France
      • Creteil, France, 94010
        • Chi De Creteil; Ophtalmologie
      • Lille, France, 59000
        • Clinique de la Louviere - Nord retine; Maladie et chirurgie des Yeux
      • Lyon, France, 69003
        • Centre ophtalmologique Rabelais; Ophtalmologie
      • Marseille, France, 13008
        • Centre Paradis Monticelli; Ophtalmologie
      • Paris, France, 75010
        • Hopital Lariboisiere; Ophtalmologie
      • Paris, France, 75012
        • CHNO des Quinze Vingts; Ophtalmologie
      • Paris Cedex 19, France, 75940
        • Fondation Rothschild; Ophtalmologie
      • Poitiers, France, 86021
        • CHU Poitiers - CHR La Miletrie; Ophtalmologie
      • St Cyr Sur Loire, France, 37540
        • Centres Ophtalmologique St Exupéry; Ophtalmologie
      • Strasbourg, France, 67000
        • Cabinet La Maison Rouge; Ophtalmologie
  • Germany
      • Leipzig, Germany, 04103
        • Universitatsklinikum Leipzig
      • München, Germany, 81675
        • Klinikum rechts der Isar der TU München; Augenklinik
      • Tuebingen, Germany, 72076
        • Universitätsklinikum Tübingen
  • Greece
      • Heraklion, Greece, 711 10
        • University General Hospital of Heraklion; Department of Ophthalmology
      • Thessaloniki, Greece, 57001
        • European Interbalkan Medical Center; Ophthalmology Dpt
  • Hungary
      • Budapest, Hungary, H-1077
        • Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
      • Budapest, Hungary, 1106
        • Bajcsy-Zsilinszky Hospital
      • Debrecen, Hungary, 4031
        • Kenezy Gyula Korhaz; Szemeszet
      • Szombathely, Hungary, 9700
        • Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET
  • Israel
      • Beer Sheva, Israel, 8489501
        • Soroka university medical center; Ophtalmology
      • Haifa, Israel, 3109600
        • Rambam Health Care Campus
      • Jerusalem, Israel, 9112001
        • Hadassah MC; Ophtalmology
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center; Ophtalmology
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center
      • Ramat Gan, Israel, 5265601
        • Chaim Sheba Medical Center
      • Rehovot, Israel, 7660101
        • Kaplan Medical Center; Ophtalmology
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky MC; Ophtalmology
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche
    • Lombardia
      • Milano, Lombardia, Italy, 20157
        • ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
      • Varese, Lombardia, Italy, 21100
        • Università degli Studi dell'Insubria; Clinica Oculistica
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
      • Pisa, Toscana, Italy, 56124
        • Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria
    • Veneto
      • Negrar - Verona, Veneto, Italy, 37024
        • Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica
  • Poland
      • Lublin, Poland, 20-079
        • Klinika Okulistyki Ogolnej w Lublinie
      • Szczecin, Poland, 70-111
        • Pomorski Uniwersytet Medyczny w Szczecinie, Zaklad Patologii Ogolnej PUM"
      • Wroclaw, Poland, 53-334
        • SPEKTRUM Osrodek Okulistyki Klinicznej
  • Spain
      • Barcelona, Spain, 08022
        • Institut de la Macula i la retina
      • Barcelona, Spain, 8025
        • Hospital de la Santa Creu i Sant Pau; Servicio de Oftalmologia
      • Sevilla, Spain, 41007
        • Hospital Universitario Virgen de la Macarena; Servicio de Oftalmologia
      • Sevilla, Spain, 41013
        • Clinica Doctores Piñero; Oftalmologia
      • Valladolid, Spain, 47012
        • Hospital Universitario Rio Hortega; Servicio de Oftalmologia
      • Valladolid, Spain, 47005
        • Hospital Clinico Universitario de Valladolid; Servicio de oftalmologia
  • United Kingdom
      • Bristol, United Kingdom, BS1 2LX
        • Bristol Eye Hospital
      • Canterbury, United Kingdom, CT1 3NG
        • Kent & Canterbury Hospital
      • Hull, United Kingdom, HU32J
        • Hull and East Yorkshire Eye Hospital
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital; Oxford Eye Hospital
      • Southhampton, United Kingdom, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
      • Sunderland, United Kingdom, SR2 9HP
        • Sunderland Eye Infirmary
      • Wakefield, United Kingdom, WF1 4DG
        • Pinderfields Hospital; Clinical Research Team, Rowan House
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Northwest Arkansas Retina Associates
    • California
      • Campbell, California, United States, 95008
        • Retinal Diagnostic Center
      • Glendale, California, United States, 91203
        • Specialty Eye Care Medical Center
      • Los Angeles, California, United States, 90095-7000
        • Jules Stein Eye Institute/ UCLA
      • Oakland, California, United States, 94609
        • East Bay Retina Consultants
    • Colorado
      • Golden, Colorado, United States, 80401
        • Colorado Retina Associates, PC
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Rand Eye
      • Naples, Florida, United States, 34103
        • Bascom Palmer Eye Institute
      • Sarasota, Florida, United States, 34239
        • Center for Sight
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Paducah Retinal Center
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Foundation for Vision Research
    • New York
      • New York, New York, United States, 10021
        • MaculaCare, PLLC
      • New York, New York, United States, 10022
        • Vitreous-Retina-Macula
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • University of North Carolina; Kittner Eye Center
      • Charlotte, North Carolina, United States, 28210
        • Char Eye Ear &Throat Assoc
      • Durham, North Carolina, United States, 27710
        • Duke University Eye Center; Vitreoretinal
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Scheie Eye Institute
    • South Carolina
      • Florence, South Carolina, United States, 29501
        • Palmetto Retina Center
    • Texas
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston
      • San Antonio, Texas, United States, 78240
        • Med Center Ophthalmology Assoc
    • Virginia
      • Norfolk, Virginia, United States, 23451
        • Wagner Macula & Retina Center

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:

  • 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)

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 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.
Cohort Geographic Atrophy
Cohort of participants with GA secondary to AMD will be evaluated for changes in GA over time.
Other: No intervention
No intervention was 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
Number of Scotomatous Points as Assessed by Mesopic Microperimetry (MP)
Time Frame: Baseline up to end of study (up to approximately 48 months)
Baseline up to end of study (up to approximately 48 months)
Macular Sensitivity as Assessed by Mesopic MP
Time Frame: Baseline up to end of study (up to approximately 48 months)
Baseline up to end of study (up to approximately 48 months)
Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Time Frame: Baseline up to end of study (up to approximately 48 months)
Baseline up to end of study (up to approximately 48 months)
BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions
Time Frame: Baseline up to end of study (up to approximately 48 months)
Baseline up to end of study (up to approximately 48 months)
Monocular and Binocular Reading Speed as Assessed by the Minnesota Low-Vision Reading Test (MNRead) or by Radner Reading Cards
Time Frame: Baseline up to end of study (up to approximately 48 months)
Baseline up to end of study (up to approximately 48 months)
Monocular and Binocular Critical Print Size as Assessed by the MNRead or by Radner Reading Cards
Time Frame: Baseline up to end of study (up to approximately 48 months)
Baseline up to end of study (up to approximately 48 months)

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
Measure Description
Time Frame
Change from Baseline in the GA area, as Assessed by Fundus Autofluorescence (FAF)
Time Frame: Baseline, end of study (up to approximately 48 months)
Baseline, end of study (up to approximately 48 months)
Change from Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Version (NEI VFQ-25) Score
Time Frame: Baseline, end of study (up to approximately 48 months)
Baseline, end of study (up to approximately 48 months)
Change from Baseline in Functional Reading Independence (FRI) Index Score
Time Frame: Baseline, end of study (up to approximately 48 months)
Baseline, end of study (up to approximately 48 months)
Percentage of Participants With Medical Events of Interest (MEIs)
Time Frame: Baseline up to end of study (up to approximately 48 months)
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.
Baseline up to end of study (up to approximately 48 months)

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.
June 24, 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.
April 14, 2017

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.
January 31, 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).
June 19, 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.
June 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.
June 24, 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 20, 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 16, 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.
  • GX29633
  • 2014-003939-19 (EudraCT Number)
  • GX29639 (Other Identifier: Hoffmann-La Roche ID)

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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