Clinical trial NCT02479386: A Study of Disease Progression in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Official title: A Multicenter, Prospective Epidemiologic Study of The Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Geographic Atrophy
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-06-24
Enrollment: 296
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Scotomatous Points as Assessed by Mesopic Microperimetry (MP)
timeFrame: Baseline up to end of study (up to approximately 48 months)
measure: Macular Sensitivity as Assessed by Mesopic MP
timeFrame: Baseline up to end of study (up to approximately 48 months)
measure: Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
timeFrame: Baseline up to end of study (up to approximately 48 months)
measure: BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions
timeFrame: Baseline up to end of study (up to approximately 48 months)
measure: Monocular and Binocular Reading Speed as Assessed by the Minnesota Low-Vision Reading Test (MNRead) or by Radner Reading Cards
timeFrame: Baseline up to end of study (up to approximately 48 months)
measure: Monocular and Binocular Critical Print Size as Assessed by the MNRead or by Radner Reading Cards
timeFrame: Baseline up to end of study (up to approximately 48 months)
Secondary outcomes:
measure: Change from Baseline in the GA area, as Assessed by Fundus Autofluorescence (FAF)
timeFrame: Baseline, end of study (up to approximately 48 months)
measure: Change from Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Version (NEI VFQ-25) Score
timeFrame: Baseline, end of study (up to approximately 48 months)
measure: Change from Baseline in Functional Reading Independence (FRI) Index Score
timeFrame: Baseline, end of study (up to approximately 48 months)
measure: Percentage of Participants With Medical Events of Interest (MEIs)
timeFrame: Baseline up to end of study (up to approximately 48 months)
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Northwest Arkansas Retina Associates
state: Arkansas
city: Campbell
country: United States
facility: Retinal Diagnostic Center
state: California
city: Glendale
country: United States
facility: Specialty Eye Care Medical Center
state: California
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute/ UCLA
state: California
city: Oakland
country: United States
facility: East Bay Retina Consultants
state: California
city: Golden
country: United States
facility: Colorado Retina Associates, PC
state: Colorado
city: Deerfield Beach
country: United States
facility: Rand Eye
state: Florida
city: Naples
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Sarasota
country: United States
facility: Center For Sight
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Paducah
country: United States
facility: Paducah Retinal Center
state: Kentucky
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Grand Rapids
country: United States
facility: Foundation for Vision Research
state: Michigan
city: New York
country: United States
facility: MaculaCare, PLLC
state: New York
city: New York
country: United States
facility: Vitreous-Retina-Macula
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina; Kittner Eye Center
state: North Carolina
city: Charlotte
country: United States
facility: Char Eye Ear &Throat Assoc
state: North Carolina
city: Durham
country: United States
facility: Duke University Eye Center; Vitreoretinal
state: North Carolina
city: Philadelphia
country: United States
facility: Scheie Eye Institute
state: Pennsylvania
city: Florence
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: San Antonio
country: United States
facility: Med Center Ophthalmology Assoc
state: Texas
city: Norfolk
country: United States
facility: Wagner Macula & Retina Center
state: Virginia
city: Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigacion
city: Capital Federal
country: Argentina
facility: Oftalmos
city: Cordoba
country: Argentina
facility: Centro Privado de Ojos Romagosa
city: Cordoba
country: Argentina
facility: Onnis Instituto oftalmológico privado
city: Mar del Plata
country: Argentina
facility: Clinica Privada de Ojos
city: Rosario
country: Argentina
facility: Centro Oftalmólogos Especialistas
city: Mona Vale
country: Australia
facility: Northern Beaches Retina Cataract Glaucoma
state: New South Wales
city: Strathfield
country: Australia
facility: Strathfield Retina Clinic
state: New South Wales
city: Waratah
country: Australia
facility: Newcastle Eye Hospital Research Foundation
state: New South Wales
city: East Melbourne
country: Australia
facility: Royal Victorian Eye and Ear Hospital
state: Victoria
city: Nedlands
country: Australia
facility: The Lions Eye Institute
state: Western Australia
city: Wien
country: Austria
facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
city: Aparecida de Goiania
country: Brazil
facility: Hospital de Olhos de Aparecida - HOA
state: GO
city: Belo Horizonte
country: Brazil
facility: Instituto da Visão
state: MG
city: Blumenau
country: Brazil
facility: Botelho Hospital da Visao
state: SC
city: Sao Paulo
country: Brazil
facility: Instituto da Visão IPEPO
state: SP
city: Sao Paulo
country: Brazil
facility: Hosp Clinicas da FMUSP
state: SP
city: Calgary
country: Canada
facility: Calgary Retina Consultants
state: Alberta
city: Boisbriand
country: Canada
facility: Institut De L'Oeil Des Laurentides
state: Quebec
city: Creteil
country: France
facility: Chi De Creteil; Ophtalmologie
city: Lille
country: France
facility: Clinique de la Louviere - Nord retine; Maladie et chirurgie des Yeux
city: Lyon
country: France
facility: Centre ophtalmologique Rabelais; Ophtalmologie
city: Marseille
country: France
facility: Centre Paradis Monticelli; Ophtalmologie
city: Paris Cedex 19
country: France
facility: Fondation Rothschild; Ophtalmologie
city: Paris
country: France
facility: Hopital Lariboisiere; Ophtalmologie
city: Paris
country: France
facility: CHNO des Quinze Vingts; Ophtalmologie
city: Poitiers
country: France
facility: CHU Poitiers - CHR La Miletrie; Ophtalmologie
city: St Cyr Sur Loire
country: France
facility: Centres Ophtalmologique St Exupéry; Ophtalmologie
city: Strasbourg
country: France
facility: Cabinet La Maison Rouge; Ophtalmologie
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; Augenklinik
city: Tuebingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion; Department of Ophthalmology
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center; Ophthalmology Dpt
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Hospital
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
city: Debrecen
country: Hungary
facility: Kenezy Gyula Korhaz; Szemeszet
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET
city: Beer Sheva
country: Israel
facility: Soroka university medical center; Ophtalmology
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah MC; Ophtalmology
city: Kfar Saba
country: Israel
facility: Meir Medical Center; Ophtalmology
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center; Ophtalmology
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky MC; Ophtalmology
city: Napoli
country: Italy
facility: Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche
state: Campania
city: Milano
country: Italy
facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
state: Lombardia
city: Varese
country: Italy
facility: Università degli Studi dell'Insubria; Clinica Oculistica
state: Lombardia
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
state: Toscana
city: Pisa
country: Italy
facility: Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria
state: Toscana
city: Negrar - Verona
country: Italy
facility: Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica
state: Veneto
city: Lublin
country: Poland
facility: Klinika Okulistyki Ogolnej w Lublinie
city: Szczecin
country: Poland
facility: Pomorski Uniwersytet Medyczny w Szczecinie, Zaklad Patologii Ogolnej PUM"
city: Wroclaw
country: Poland
facility: SPEKTRUM Osrodek Okulistyki Klinicznej
city: Barcelona
country: Spain
facility: Institut de la Macula i la retina
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oftalmologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena; Servicio de Oftalmologia
city: Sevilla
country: Spain
facility: Clinica Doctores Piñero; Oftalmologia
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid; Servicio de oftalmologia
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital
city: Canterbury
country: United Kingdom
facility: Kent & Canterbury Hospital
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Eye Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital; Oxford Eye Hospital
city: Southhampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
city: Sunderland
country: United Kingdom
facility: Sunderland Eye Infirmary
city: Wakefield
country: United Kingdom
facility: Pinderfields Hospital; Clinical Research Team, Rowan House
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: