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

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: Terminated
• Conditions: Geographic Atrophy
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 296

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1015ABO
    • Organizacion Medica de Investigacion
  • 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
    • Universitätsklinikum 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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Time Frame
Number of Scotomatous Points as Assessed by Mesopic Microperimetry (MP)	Baseline up to end of study (up to approximately 48 months)
Macular Sensitivity as Assessed by Mesopic MP	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	Baseline up to end of study (up to approximately 48 months)
BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions	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	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	Baseline up to end of study (up to approximately 48 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the GA area, as Assessed by Fundus Autofluorescence (FAF)		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		Baseline, end of study (up to approximately 48 months)
Change from Baseline in Functional Reading Independence (FRI) Index Score		Baseline, end of study (up to approximately 48 months)
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.	Baseline up to end of study (up to approximately 48 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2015
• Primary Completion (Actual): April 14, 2017
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: June 19, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (Estimate): June 24, 2015

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 16, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Pathological Conditions, Anatomical; Macular Degeneration; Geographic Atrophy; Atrophy
• Other Study ID Numbers: GX29633; 2014-003939-19 (EudraCT Number); GX29639 (Other Identifier: Hoffmann-La Roche ID)