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Geographic AtrophyNCT02399072

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

An observational study of Geographic Atrophy, run by Hoffmann-La Roche at 63 sites in 12 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 also will 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
202 participants
Where
63 sitesin 12 countries
Study dates
30 Mar 2015to 8 Feb 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

  • 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

Who cannot join

  • 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

Trial locations and contacts

63 sites in 12 countries.

63 sites in 12 countries

United States11 sites

  • Retina Res Institute of Texas

    Abilene, Texas, 79606

  • Char Eye Ear &Throat Assoc

    Charlotte, North Carolina, 28210

  • Midwest Vision Research Foundation

    Chesterfield, Missouri, 63017

  • Retina Assoc of Cleveland Inc

    Cleveland, Ohio, 44122

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Palmetto Retina Center

    Florence, South Carolina, 29501

  • West Virginia University Eye Institute

    Morgantown, West Virginia, 26506

  • Tennessee Retina PC.

    Nashville, Tennessee, 37203

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Retina Consultants of Houston

    The Woodlands, Texas, 77384

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

Other trials in United States

France9 sites

  • Chi De Creteil; Ophtalmologie

    Créteil, 94010

  • CHU Bocage; Ophtalmologie

    Dijon, 21079

  • Hopital de la croix rousse; Ophtalmologie

    Lyon, 69317

  • Centre Paradis Monticelli; Ophtalmologie

    Marseille, 13008

  • Centre Odeon; Exploration Ophtalmologique

    Paris, 75006

  • Hopital Lariboisiere; Ophtalmologie

    Paris, 75010

  • CHNO des Quinze Vingts; Ophtalmologie

    Paris, 75012

  • CHU Poitiers - CHR La Miletrie; Ophtalmologie

    Poitiers, 86021

  • Centres Ophtalmologique St Exupéry; Ophtalmologie

    Saint-Cyr-sur-Loire, 37540

Other trials in France

Poland7 sites

  • OFTALMIKA Sp. z o.o

    Bydgoszcz, 85-631

  • Szpital Specjalistyczny nr 1; Oddzial Okulistyki

    Bytom, 41-902

  • Optimum Profesorskie Centrum Okulistyki

    Gdansk, 80-809

  • Gabinet Okulistyczny Prof Edward Wylegala

    Katowice, 40-594

  • SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

    Krakow, 31-501

  • Klinika Okulistyczna Jasne Błonia

    Lodz, 91-134

  • SPEKTRUM Osrodek Okulistyki Klinicznej

    Wroclaw, 53-334

Other trials in Poland

Canada6 sites

  • Institut De L'Oeil Des Laurentides

    Boisbriand, Quebec, J7H 1S6

  • QEII - HSC Department of Ophthalmology

    Halifax, Nova Scotia, B3H 2Y9

  • Hôpital Maisonneuve - Rosemont

    Montreal, Quebec, H1T 2M4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • University of British Columbia

    Vancouver, British Columbia, V6T 1Z4

Other trials in Canada

Argentina5 sites

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO

  • Oftalmos

    Capital Federal, C1120AAN

  • Centro Privado de Ojos Romagosa

    Córdoba

  • Onnis Instituto oftalmológico privado

    Córdoba

  • Oftar

    Mendoza, M5500GGK

Other trials in Argentina

Hungary5 sites

  • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

    Budapest, 1076

  • Semmelweis Egyetem AOK, Szemeszeti Klinika

    Budapest, 1083

  • Budapest Retina Associates Kft.

    Budapest, 1133

  • Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

    Debrecem, 4032

  • Ganglion Medial Center

    Pécs, 7621

Other trials in Hungary

Australia4 sites

  • Adelaide Eye and Retina Centre

    Adelaide, South Australia, 5000

  • Royal Victorian Eye and Ear Hospital

    East Melbourne, Victoria, 3002

  • The Lions Eye Institute

    Nedlands, Western Australia, 6009

  • Marsden Eye Research Centre

    Parramatta, New South Wales, 2150

Other trials in Australia

Germany4 sites

  • Universitäts-Augenklinik Bonn

    Bonn, 53127

  • Universitätsklinikum Köln; Augenklinik

    Cologne, 50937

  • Universitätsklinikum Münster; Augenheilkunde

    Münster, 48149

  • Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

    Regensburg, 93053

Other trials in Germany

Spain4 sites

  • Institut de la Macula i la retina

    Barcelona, 08022

  • Hospital Universitari de Bellvitge; Servicio de Oftalmologia

    L'Hospitalet de Llobregat, Barcelona, 8907

  • Clinica Universitaria de Navarra; Servicio de Oftalmologia

    Pamplona, Navarre, 31008

  • Hospital General de Catalunya

    San Cugat Del Valles, Barcelona, 08195

Other trials in Spain

United Kingdom4 sites

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ

  • Bristol Eye Hospital

    Bristol, BS1 2LX

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD

  • University Hospital Southampton NHS Foundation Trust

    Southhampton, SO16 6YD

Other trials in United Kingdom

Brazil2 sites

  • Instituto da Visão IPEPO

    São Paulo, São Paulo, 04038-032

  • Hosp Clinicas da FMUSP

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Italy2 sites

  • ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

    Milan, Lombardy, 20157

  • Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

    Rome, Lazio, 00133

Other trials in Italy

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 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.

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 administered in this study

Study groups in NCT02399072
Study groupRoleWhat they receive
Geographic Atrophy ParticipantsParticipants 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.
Receives: Other: No intervention

What is being measured

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

  1. Mean Change from Baseline in the GA Area as Assessed by Fundus Autofluorescence (FAF) up to Month 60

    Measured: Baseline up to Month 60

Secondary outcomes (12)

  1. Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart up to Month 60

    Measured: Baseline up to Month 60

  2. Change from Baseline in BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions up to Month 60

    Measured: Baseline up to Month 60

  3. 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

    Measured: Baseline up to Month 60

  4. Change from Baseline in Monocular Reading Speed as Assessed by MNRead Cards or Radner Reading Cards up to Month 60

    Measured: Baseline up to Month 60

  5. Change from Baseline in Binocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60

    Measured: Baseline up to Month 60

  6. Change from Baseline in Monocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60

    Measured: Baseline up to Month 60

  7. 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

    Measured: Baseline up to Month 60

  8. Change from Baseline in Distance Activity Subscale as Assessed by NEI VFQ-25 up to Month 60

    Measured: Baseline up to Month 60

  9. Change from Baseline in Composite Scores as Assessed by NEI VFQ-25 up to Month 60

    Measured: Baseline up to Month 60

  10. Change from Baseline in Functional Reading Independence Score up to Month 60

    Measured: Baseline up to Month 60

  11. Percentage of Participants With Medical Events

    Measured: Baseline up to Month 60

  12. Percentage of Participants With Ocular Events

    Measured: Baseline up to Month 60

Timeline

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

  1. First posted26 Mar 2015 (estimated)
  2. Study start30 Mar 2015
  3. Primary completion8 Feb 2018
  4. Study completion8 Feb 2018

Why it stopped: There is no longer a plan to pursue an approval of lampalizumab.

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
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02399072
Sponsor's protocol ID
GX29639
Other IDs
2014-003940-11, GX29639, 2014
Status last verified
Aug 2019
First submitted
23 Mar 2015
Last updated
9 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
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

  • Schmitz-Valckenberg S, Sassmannshausen M, Braun M, Steffen V, Gao SS, Honigberg L, Ferrara D, Pfau M, Holz FG. Interreader Agreement and Longitudinal Progression of Incomplete/Complete Retinal Pigment Epithelium and Outer Retinal Atrophy in Age-Related Macular Degeneration. Ophthalmol Retina. 2023 Dec;7(12):1059-1068. doi: 10.1016/j.oret.2023.07.021. Epub 2023 Jul 29.

    PubMed 37517799

  • 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 63 sites in 12 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 4 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 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, France, Poland, Canada, Argentina and 7 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 (reason given: There is no longer a plan to pursue an approval of lampalizumab.). 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?

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). 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 NCT02399072, which also lists 3 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 9 Aug 2019.

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