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

NCT02479386 | Terminated

• 3 other identifiers: GX296332014-003939-19GX29639
• Study Type: observational
• Target: 296
• Locations: 14 countries
• Sites: 86

Brief 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. 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.

Conditions

Geographic Atrophy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• 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)

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

Study Arms (1)

Cohort Geographic Atrophy

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

Other: No intervention

Interventions

No intervention OTHER

No intervention was administered in this study.

Cohort Geographic Atrophy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (91)

Northwest Arkansas Retina Associates

Springdale, Arkansas, 72764, United States

Location

Retinal Diagnostic Center

Campbell, California, 95008, United States

Location

Specialty Eye Care Medical Center

Glendale, California, 91203, United States

Location

Jules Stein Eye Institute/ UCLA

Los Angeles, California, 90095-7000, United States

Location

East Bay Retina Consultants

Oakland, California, 94609, United States

Location

Colorado Retina Associates, PC

Golden, Colorado, 80401, United States

Location

Rand Eye

Deerfield Beach, Florida, 33064, United States

Location

Bascom Palmer Eye Institute

Naples, Florida, 34103, United States

Location

Center For Sight

Sarasota, Florida, 34239, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Paducah Retinal Center

Paducah, Kentucky, 42001, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Foundation for Vision Research

Grand Rapids, Michigan, 49546, United States

Location

MaculaCare, PLLC

New York, New York, 10021, United States

Location

Vitreous-Retina-Macula

New York, New York, 10022, United States

Location

University of North Carolina; Kittner Eye Center

Chapel Hill, North Carolina, 27517, United States

Location

Char Eye Ear &Throat Assoc

Charlotte, North Carolina, 28210, United States

Location

Duke University Eye Center; Vitreoretinal

Durham, North Carolina, 27710, United States

Location

Scheie Eye Institute

Philadelphia, Pennsylvania, 19104, United States

Location

Palmetto Retina Center

Florence, South Carolina, 29501, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Med Center Ophthalmology Assoc

San Antonio, Texas, 78240, United States

Location

Wagner Macula & Retina Center

Norfolk, Virginia, 23451, United States

Location

Organizacion Medica de Investigacion

Buenos Aires, C1015ABO, Argentina

Location

Oftalmos

Capital Federal, C1120AAN, Argentina

Location

Centro Privado de Ojos Romagosa

Córdoba, Argentina

Location

Onnis Instituto oftalmológico privado

Córdoba, Argentina

Location

Clinica Privada de Ojos

Mar del Plata, B7600DFC, Argentina

Location

Centro Oftalmólogos Especialistas

Rosario, S2000ANJ, Argentina

Location

Northern Beaches Retina Cataract Glaucoma

Mona Vale, New South Wales, 2103, Australia

Location

Strathfield Retina Clinic

Strathfield, New South Wales, 2135, Australia

Location

Newcastle Eye Hospital Research Foundation

Waratah, New South Wales, 2298, Australia

Location

Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, 3002, Australia

Location

The Lions Eye Institute

Nedlands, Western Australia, 6009, Australia

Location

Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

Vienna, 1090, Austria

Location

Hospital de Olhos de Aparecida - HOA

Aparecida de Goiânia, Goiás, 74980-010, Brazil

Location

Instituto da Visão

Belo Horizonte, Minas Gerais, 30150-270, Brazil

Location

Botelho Hospital da Visao

Blumenau, Santa Catarina, 89052-504, Brazil

Location

Instituto da Visão IPEPO

São Paulo, São Paulo, 04038-032, Brazil

Location

Hosp Clinicas da FMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

Calgary Retina Consultants

Calgary, Alberta, T2J 0C8, Canada

Location

Institut De L'Oeil Des Laurentides

Boisbriand, Quebec, J7H 1S6, Canada

Location

Chi De Creteil; Ophtalmologie

Créteil, 94010, France

Location

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

Lille, 59000, France

Location

Centre ophtalmologique Rabelais; Ophtalmologie

Lyon, 69003, France

Location

Centre Paradis Monticelli; Ophtalmologie

Marseille, 13008, France

Location

Hopital Lariboisiere; Ophtalmologie

Paris, 75010, France

Location

CHNO des Quinze Vingts; Ophtalmologie

Paris, 75012, France

Location

Fondation Rothschild; Ophtalmologie

Paris, 75940, France

Location

CHU Poitiers - CHR La Miletrie; Ophtalmologie

Poitiers, 86021, France

Location

Centres Ophtalmologique St Exupéry; Ophtalmologie

Saint-Cyr-sur-Loire, 37540, France

Location

Cabinet La Maison Rouge; Ophtalmologie

Strasbourg, 67000, France

Location

Universitatsklinikum Leipzig

Leipzig, 04103, Germany

Location

Klinikum rechts der Isar der TU München; Augenklinik

München, 81675, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

University General Hospital of Heraklion; Department of Ophthalmology

Heraklion, 711 10, Greece

Location

European Interbalkan Medical Center; Ophthalmology Dpt

Thessaloniki, 57001, Greece

Location

Bajcsy-Zsilinszky Hospital

Budapest, 1106, Hungary

Location

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

Budapest, H-1077, Hungary

Location

Kenezy Gyula Korhaz; Szemeszet

Debrecen, 4031, Hungary

Location

Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

Szombathely, 9700, Hungary

Location

Soroka university medical center; Ophtalmology

Beersheba, 8489501, Israel

Location

Rambam Health Care Campus

Haifa, 3109600, Israel

Location

Hadassah MC; Ophtalmology

Jerusalem, 9112001, Israel

Location

Meir Medical Center; Ophtalmology

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Kaplan Medical Center; Ophtalmology

Rehovot, 7660101, Israel

Location

Tel Aviv Sourasky MC; Ophtalmology

Tel Aviv, 6423906, Israel

Location

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

Napoli, Campania, 80131, Italy

Location

ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

Milan, Lombardy, 20157, Italy

Location

Università degli Studi dell'Insubria; Clinica Oculistica

Varese, Lombardy, 21100, Italy

Location

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

Florence, Tuscany, 50134, Italy

Location

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

Pisa, Tuscany, 56124, Italy

Location

Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica

Negrar - Verona, Veneto, 37024, Italy

Location

Klinika Okulistyki Ogolnej w Lublinie

Lublin, 20-079, Poland

Location

Pomorski Uniwersytet Medyczny w Szczecinie, Zaklad Patologii Ogolnej PUM"

Szczecin, 70-111, Poland

Location

SPEKTRUM Osrodek Okulistyki Klinicznej

Wroclaw, 53-334, Poland

Location

Institut de la Macula i la retina

Barcelona, 08022, Spain

Location

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

Barcelona, 8025, Spain

Location

Hospital Universitario Virgen de la Macarena; Servicio de Oftalmologia

Seville, 41007, Spain

Location

Clinica Doctores Piñero; Oftalmologia

Seville, 41013, Spain

Location

Hospital Clinico Universitario de Valladolid; Servicio de oftalmologia

Valladolid, 47005, Spain

Location

Hospital Universitario Rio Hortega; Servicio de Oftalmologia

Valladolid, 47012, Spain

Location

Bristol Eye Hospital

Bristol, BS1 2LX, United Kingdom

Location

Kent & Canterbury Hospital

Canterbury, CT1 3NG, United Kingdom

Location

Hull and East Yorkshire Eye Hospital

Hull, HU32J, United Kingdom

Location

John Radcliffe Hospital; Oxford Eye Hospital

Oxford, OX3 9DU, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southhampton, SO16 6YD, United Kingdom

Location

Sunderland Eye Infirmary

Sunderland, SR2 9HP, United Kingdom

Location

Pinderfields Hospital; Clinical Research Team, Rowan House

Wakefield, WF1 4DG, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 39758130 DERIVED

• 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.

  PMID: 39581330 DERIVED

• 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.

  PMID: 39102242 DERIVED

• 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.

  PMID: 37428131 DERIVED

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: June 24, 2015
• Study Start: June 24, 2015
• Primary Completion: April 14, 2017
• Study Completion: January 31, 2018
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

AU (1); IL (8); IT (6); FR (10); BR (5); GR (2); CA (2); GB (7); AR (6); ES (6); PL (3); HU (4); DE (3); US (23)