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

NCT ID: NCT02479386

Last Updated: 2019-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

296 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-24

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Geographic Atrophy

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort Geographic Atrophy

Cohort of participants with GA secondary to AMD will be evaluated for changes in GA over time.

No intervention

Intervention Type OTHER

No intervention was administered in this study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

No intervention was administered in this study.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northwest Arkansas Retina Associates

Springdale, Arkansas, United States

Site Status

Retinal Diagnostic Center

Campbell, California, United States

Site Status

Specialty Eye Care Medical Center

Glendale, California, United States

Site Status

Jules Stein Eye Institute/ UCLA

Los Angeles, California, United States

Site Status

East Bay Retina Consultants

Oakland, California, United States

Site Status

Colorado Retina Associates, PC

Golden, Colorado, United States

Site Status

Rand Eye

Deerfield Beach, Florida, United States

Site Status

Bascom Palmer Eye Institute

Naples, Florida, United States

Site Status

Center For Sight

Sarasota, Florida, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Paducah Retinal Center

Paducah, Kentucky, United States

Site Status

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Site Status

Foundation for Vision Research

Grand Rapids, Michigan, United States

Site Status

MaculaCare, PLLC

New York, New York, United States

Site Status

Vitreous-Retina-Macula

New York, New York, United States

Site Status

University of North Carolina; Kittner Eye Center

Chapel Hill, North Carolina, United States

Site Status

Char Eye Ear &Throat Assoc

Charlotte, North Carolina, United States

Site Status

Duke University Eye Center; Vitreoretinal

Durham, North Carolina, United States

Site Status

Scheie Eye Institute

Philadelphia, Pennsylvania, United States

Site Status

Palmetto Retina Center

Florence, South Carolina, United States

Site Status

Retina Consultants of Houston

Houston, Texas, United States

Site Status

Med Center Ophthalmology Assoc

San Antonio, Texas, United States

Site Status

Wagner Macula & Retina Center

Norfolk, Virginia, United States

Site Status

Organizacion Medica de Investigacion

Buenos Aires, , Argentina

Site Status

Oftalmos

Capital Federal, , Argentina

Site Status

Centro Privado de Ojos Romagosa

Córdoba, , Argentina

Site Status

Onnis Instituto oftalmológico privado

Córdoba, , Argentina

Site Status

Clinica Privada de Ojos

Mar del Plata, , Argentina

Site Status

Centro Oftalmólogos Especialistas

Rosario, , Argentina

Site Status

Northern Beaches Retina Cataract Glaucoma

Mona Vale, New South Wales, Australia

Site Status

Strathfield Retina Clinic

Strathfield, New South Wales, Australia

Site Status

Newcastle Eye Hospital Research Foundation

Waratah, New South Wales, Australia

Site Status

Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, Australia

Site Status

The Lions Eye Institute

Nedlands, Western Australia, Australia

Site Status

Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

Vienna, , Austria

Site Status

Hospital de Olhos de Aparecida - HOA

Aparecida de Goiânia, Goiás, Brazil

Site Status

Instituto da Visão

Belo Horizonte, Minas Gerais, Brazil

Site Status

Botelho Hospital da Visao

Blumenau, Santa Catarina, Brazil

Site Status

Instituto da Visão IPEPO

São Paulo, São Paulo, Brazil

Site Status

Hosp Clinicas da FMUSP

São Paulo, São Paulo, Brazil

Site Status

Calgary Retina Consultants

Calgary, Alberta, Canada

Site Status

Institut De L'Oeil Des Laurentides

Boisbriand, Quebec, Canada

Site Status

Chi De Creteil; Ophtalmologie

Créteil, , France

Site Status

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

Lille, , France

Site Status

Centre ophtalmologique Rabelais; Ophtalmologie

Lyon, , France

Site Status

Centre Paradis Monticelli; Ophtalmologie

Marseille, , France

Site Status

Hopital Lariboisiere; Ophtalmologie

Paris, , France

Site Status

CHNO des Quinze Vingts; Ophtalmologie

Paris, , France

Site Status

Fondation Rothschild; Ophtalmologie

Paris, , France

Site Status

CHU Poitiers - CHR La Miletrie; Ophtalmologie

Poitiers, , France

Site Status

Centres Ophtalmologique St Exupéry; Ophtalmologie

Saint-Cyr-sur-Loire, , France

Site Status

Cabinet La Maison Rouge; Ophtalmologie

Strasbourg, , France

Site Status

Universitatsklinikum Leipzig

Leipzig, , Germany

Site Status

Klinikum rechts der Isar der TU München; Augenklinik

München, , Germany

Site Status

Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status

University General Hospital of Heraklion; Department of Ophthalmology

Heraklion, , Greece

Site Status

European Interbalkan Medical Center; Ophthalmology Dpt

Thessaloniki, , Greece

Site Status

Bajcsy-Zsilinszky Hospital

Budapest, , Hungary

Site Status

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

Budapest, , Hungary

Site Status

Kenezy Gyula Korhaz; Szemeszet

Debrecen, , Hungary

Site Status

Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

Szombathely, , Hungary

Site Status

Soroka university medical center; Ophtalmology

Beersheba, , Israel

Site Status

Rambam Health Care Campus

Haifa, , Israel

Site Status

Hadassah MC; Ophtalmology

Jerusalem, , Israel

Site Status

Meir Medical Center; Ophtalmology

Kfar Saba, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

Site Status

Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status

Kaplan Medical Center; Ophtalmology

Rehovot, , Israel

Site Status

Tel Aviv Sourasky MC; Ophtalmology

Tel Aviv, , Israel

Site Status

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

Napoli, Campania, Italy

Site Status

ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

Milan, Lombardy, Italy

Site Status

Università degli Studi dell'Insubria; Clinica Oculistica

Varese, Lombardy, Italy

Site Status

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

Florence, Tuscany, Italy

Site Status

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

Pisa, Tuscany, Italy

Site Status

Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica

Negrar - Verona, Veneto, Italy

Site Status

Klinika Okulistyki Ogolnej w Lublinie

Lublin, , Poland

Site Status

Pomorski Uniwersytet Medyczny w Szczecinie, Zaklad Patologii Ogolnej PUM"

Szczecin, , Poland

Site Status

SPEKTRUM Osrodek Okulistyki Klinicznej

Wroclaw, , Poland

Site Status

Institut de la Macula i la retina

Barcelona, , Spain

Site Status

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

Barcelona, , Spain

Site Status

Hospital Universitario Virgen de la Macarena; Servicio de Oftalmologia

Seville, , Spain

Site Status

Clinica Doctores Piñero; Oftalmologia

Seville, , Spain

Site Status

Hospital Clinico Universitario de Valladolid; Servicio de oftalmologia

Valladolid, , Spain

Site Status

Hospital Universitario Rio Hortega; Servicio de Oftalmologia

Valladolid, , Spain

Site Status

Bristol Eye Hospital

Bristol, , United Kingdom

Site Status

Kent & Canterbury Hospital

Canterbury, , United Kingdom

Site Status

Hull and East Yorkshire Eye Hospital

Hull, , United Kingdom

Site Status

John Radcliffe Hospital; Oxford Eye Hospital

Oxford, , United Kingdom

Site Status

University Hospital Southampton NHS Foundation Trust

Southhampton, , United Kingdom

Site Status

Sunderland Eye Infirmary

Sunderland, , United Kingdom

Site Status

Pinderfields Hospital; Clinical Research Team, Rowan House

Wakefield, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Austria Brazil Canada France Germany Greece Hungary Israel Italy Poland Spain United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39758130 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39581330 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39102242 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37428131 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-003939-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GX29639

Identifier Type: OTHER

Identifier Source: secondary_id

GX29633

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.