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Geographic AtrophyProxima ANCT02479386

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

An observational study of Geographic Atrophy, run by Hoffmann-La Roche at 91 sites in 15 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Geographic Atrophy
How many people
296 participants
Where
91 sitesin 15 countries
Study dates
24 Jun 2015to 31 Jan 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

91 sites in 15 countries.

91 sites in 15 countries

United States23 sites

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Retinal Diagnostic Center

    Campbell, California, 95008

  • University of North Carolina; Kittner Eye Center

    Chapel Hill, North Carolina, 27517

  • Char Eye Ear &Throat Assoc

    Charlotte, North Carolina, 28210

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Rand Eye

    Deerfield Beach, Florida, 33064

  • Duke University Eye Center; Vitreoretinal

    Durham, North Carolina, 27710

  • Palmetto Retina Center

    Florence, South Carolina, 29501

  • Specialty Eye Care Medical Center

    Glendale, California, 91203

  • Colorado Retina Associates, PC

    Golden, Colorado, 80401

  • Foundation for Vision Research

    Grand Rapids, Michigan, 49546

  • Retina Consultants of Houston

    Houston, Texas, 77030

  • Jules Stein Eye Institute/ UCLA

    Los Angeles, California, 90095-7000

  • Bascom Palmer Eye Institute

    Naples, Florida, 34103

  • MaculaCare, PLLC

    New York, New York, 10021

  • Vitreous-Retina-Macula

    New York, New York, 10022

  • Wagner Macula & Retina Center

    Norfolk, Virginia, 23451

  • East Bay Retina Consultants

    Oakland, California, 94609

  • Paducah Retinal Center

    Paducah, Kentucky, 42001

  • Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

  • Med Center Ophthalmology Assoc

    San Antonio, Texas, 78240

  • Center For Sight

    Sarasota, Florida, 34239

  • Northwest Arkansas Retina Associates

    Springdale, Arkansas, 72764

Other trials in United States

France10 sites

  • Chi De Creteil; Ophtalmologie

    Créteil, 94010

  • Clinique de la Louviere - Nord retine; Maladie et chirurgie des Yeux

    Lille, 59000

  • Centre ophtalmologique Rabelais; Ophtalmologie

    Lyon, 69003

  • Centre Paradis Monticelli; Ophtalmologie

    Marseille, 13008

  • Hopital Lariboisiere; Ophtalmologie

    Paris, 75010

  • CHNO des Quinze Vingts; Ophtalmologie

    Paris, 75012

  • Fondation Rothschild; Ophtalmologie

    Paris, 75940

  • CHU Poitiers - CHR La Miletrie; Ophtalmologie

    Poitiers, 86021

  • Centres Ophtalmologique St Exupéry; Ophtalmologie

    Saint-Cyr-sur-Loire, 37540

  • Cabinet La Maison Rouge; Ophtalmologie

    Strasbourg, 67000

Other trials in France

Israel8 sites

  • Soroka university medical center; Ophtalmology

    Beersheba, 8489501

  • Rambam Health Care Campus

    Haifa, 3109600

  • Hadassah MC; Ophtalmology

    Jerusalem, 9112001

  • Meir Medical Center; Ophtalmology

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Kaplan Medical Center; Ophtalmology

    Rehovot, 7660101

  • Tel Aviv Sourasky MC; Ophtalmology

    Tel Aviv, 6423906

Other trials in Israel

United Kingdom7 sites

  • Bristol Eye Hospital

    Bristol, BS1 2LX

  • Kent & Canterbury Hospital

    Canterbury, CT1 3NG

  • Hull and East Yorkshire Eye Hospital

    Hull, HU32J

  • John Radcliffe Hospital; Oxford Eye Hospital

    Oxford, OX3 9DU

  • University Hospital Southampton NHS Foundation Trust

    Southhampton, SO16 6YD

  • Sunderland Eye Infirmary

    Sunderland, SR2 9HP

  • Pinderfields Hospital; Clinical Research Team, Rowan House

    Wakefield, WF1 4DG

Other trials in United Kingdom

Argentina6 sites

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO

  • Oftalmos

    Capital Federal, C1120AAN

  • Centro Privado de Ojos Romagosa

    Córdoba

  • Onnis Instituto oftalmológico privado

    Córdoba

  • Clinica Privada de Ojos

    Mar del Plata, B7600DFC

  • Centro Oftalmólogos Especialistas

    Rosario, S2000ANJ

Other trials in Argentina

Italy6 sites

  • Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

    Florence, Tuscany, 50134

  • ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

    Milan, Lombardy, 20157

  • Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche

    Naples, Campania, 80131

  • Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica

    Negrar - Verona, Veneto, 37024

  • Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria

    Pisa, Tuscany, 56124

  • Università degli Studi dell'Insubria; Clinica Oculistica

    Varese, Lombardy, 21100

Other trials in Italy

Spain6 sites

  • Institut de la Macula i la retina

    Barcelona, BARCELONA, 08022

  • Hospital de la Santa Creu i Sant Pau; Servicio de Oftalmologia

    Barcelona, BARCELONA, 8025

  • Hospital Universitario Virgen de la Macarena; Servicio de Oftalmologia

    Seville, SEVILLA, 41007

  • Clinica Doctores Piñero; Oftalmologia

    Seville, SEVILLA, 41013

  • Hospital Clinico Universitario de Valladolid; Servicio de oftalmologia

    Valladolid, VALLADOLID, 47005

  • Hospital Universitario Rio Hortega; Servicio de Oftalmologia

    Valladolid, VALLADOLID, 47012

Other trials in Spain

Australia5 sites

  • Royal Victorian Eye and Ear Hospital

    East Melbourne, Victoria, 3002

  • Northern Beaches Retina Cataract Glaucoma

    Mona Vale, New South Wales, 2103

  • The Lions Eye Institute

    Nedlands, Western Australia, 6009

  • Strathfield Retina Clinic

    Strathfield, New South Wales, 2135

  • Newcastle Eye Hospital Research Foundation

    Waratah, New South Wales, 2298

Other trials in Australia

Brazil5 sites

  • Hospital de Olhos de Aparecida - HOA

    Aparecida de Goiânia, Goiás, 74980-010

  • Instituto da Visão

    Belo Horizonte, Minas Gerais, 30150-270

  • Botelho Hospital da Visao

    Blumenau, Santa Catarina, 89052-504

  • Instituto da Visão IPEPO

    São Paulo, São Paulo, 04038-032

  • Hosp Clinicas da FMUSP

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Hungary4 sites

  • Bajcsy-Zsilinszky Hospital

    Budapest, 1106

  • Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

    Budapest, H-1077

  • Kenezy Gyula Korhaz; Szemeszet

    Debrecen, 4031

  • Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

    Szombathely, 9700

Other trials in Hungary

Germany3 sites

  • Universitatsklinikum Leipzig

    Leipzig, 04103

  • Klinikum rechts der Isar der TU München; Augenklinik

    München, 81675

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

Poland3 sites

  • Klinika Okulistyki Ogolnej w Lublinie

    Lublin, 20-079

  • Pomorski Uniwersytet Medyczny w Szczecinie, Zaklad Patologii Ogolnej PUM"

    Szczecin, 70-111

  • SPEKTRUM Osrodek Okulistyki Klinicznej

    Wroclaw, 53-334

Other trials in Poland

Canada2 sites

  • Institut De L'Oeil Des Laurentides

    Boisbriand, Quebec, J7H 1S6

  • Calgary Retina Consultants

    Calgary, Alberta, T2J 0C8

Other trials in Canada

Greece2 sites

  • University General Hospital of Heraklion; Department of Ophthalmology

    Heraklion, 711 10

  • European Interbalkan Medical Center; Ophthalmology Dpt

    Thessaloniki, 57001

Other trials in Greece

Austria1 site

  • Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

    Vienna, 1090

Other trials in Austria

About this study

Official title: 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.

Being tested
No intervention
Medical subject headings
Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention was administered in this study.

Study groups in NCT02479386
Study groupRoleWhat they receive
Cohort Geographic AtrophyCohort of participants with GA secondary to AMD will be evaluated for changes in GA over time.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Scotomatous Points as Assessed by Mesopic Microperimetry (MP)

    Measured: Baseline up to end of study (up to approximately 48 months)

  2. Macular Sensitivity as Assessed by Mesopic MP

    Measured: Baseline up to end of study (up to approximately 48 months)

  3. Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart

    Measured: Baseline up to end of study (up to approximately 48 months)

  4. BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions

    Measured: Baseline up to end of study (up to approximately 48 months)

  5. Monocular and Binocular Reading Speed as Assessed by the Minnesota Low-Vision Reading Test (MNRead) or by Radner Reading Cards

    Measured: Baseline up to end of study (up to approximately 48 months)

  6. Monocular and Binocular Critical Print Size as Assessed by the MNRead or by Radner Reading Cards

    Measured: Baseline up to end of study (up to approximately 48 months)

Secondary outcomes (4)

  1. Change from Baseline in the GA area, as Assessed by Fundus Autofluorescence (FAF)

    Measured: Baseline, end of study (up to approximately 48 months)

  2. Change from Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Version (NEI VFQ-25) Score

    Measured: Baseline, end of study (up to approximately 48 months)

  3. Change from Baseline in Functional Reading Independence (FRI) Index Score

    Measured: Baseline, end of study (up to approximately 48 months)

  4. 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.

    Measured: Baseline up to end of study (up to approximately 48 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2015 (estimated)
  2. Study start24 Jun 2015
  3. Primary completion14 Apr 2017
  4. Study completion31 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02479386
Sponsor's protocol ID
GX29633
Other IDs
2014-003939-19, GX29639, 2014
Acronym
Proxima A
Status last verified
Aug 2019
First submitted
19 Jun 2015
Last updated
26 Aug 2026
Results posted
No

Publications

  • Salvi A, Cluceru J, Gao SS, Rabe C, Schiffman C, Yang Q, Lee AY, Keane PA, Sadda SR, Holz FG, Ferrara D, Anegondi N. Deep Learning to Predict the Future Growth of Geographic Atrophy from Fundus Autofluorescence. Ophthalmol Sci. 2024 Oct 23;5(2):100635. doi: 10.1016/j.xops.2024.100635. eCollection 2025 Mar-Apr.

    PubMed 39758130

  • Anegondi N, Steffen V, Sadda SR, Schmitz-Valckenberg S, Tufail A, Csaky K, Lad EM, Kaiser PK, Ferrara D, Chakravarthy U. Visual Loss in Geographic Atrophy: Learnings from the Lampalizumab Trials. Ophthalmology. 2025 Apr;132(4):420-430. doi: 10.1016/j.ophtha.2024.11.017. Epub 2024 Nov 23.

    PubMed 39581330

  • Cluceru J, Anegondi N, Gao SS, Lee AY, Lad EM, Chakravarthy U, Yang Q, Steffen V, Friesenhahn M, Rabe C, Ferrara D. Topographic Clinical Insights From Deep Learning-Based Geographic Atrophy Progression Prediction. Transl Vis Sci Technol. 2024 Aug 1;13(8):6. doi: 10.1167/tvst.13.8.6.

    PubMed 39102242

  • Spaide T, Jiang J, Patil J, Anegondi N, Steffen V, Kawczynski MG, Newton EM, Rabe C, Gao SS, Lee AY, Holz FG, Sadda S, Schmitz-Valckenberg S, Ferrara D. Geographic Atrophy Segmentation Using Multimodal Deep Learning. Transl Vis Sci Technol. 2023 Jul 3;12(7):10. doi: 10.1167/tvst.12.7.10.

    PubMed 37428131

Questions about this trial

What is this clinical trial studying?

An observational study of Geographic Atrophy, run by Hoffmann-La Roche at 91 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, France, Israel, United Kingdom, Argentina and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Scotomatous Points as Assessed by Mesopic Microperimetry (MP) (time frame: Baseline up to end of study (up to approximately 48 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02479386, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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