Clinical trial NCT02399072: 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: 2015-03-26
Enrollment: 202
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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Change from Baseline in the GA Area as Assessed by Fundus Autofluorescence (FAF) up to Month 60
timeFrame: Baseline up to Month 60
Secondary outcomes:
measure: Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart up to Month 60
timeFrame: Baseline up to Month 60
measure: Change from Baseline in BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions up to Month 60
timeFrame: Baseline up to Month 60
measure: 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
timeFrame: Baseline up to Month 60
measure: Change from Baseline in Monocular Reading Speed as Assessed by MNRead Cards or Radner Reading Cards up to Month 60
timeFrame: Baseline up to Month 60
measure: Change from Baseline in Binocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60
timeFrame: Baseline up to Month 60
measure: Change from Baseline in Monocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60
timeFrame: Baseline up to Month 60
measure: 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
timeFrame: Baseline up to Month 60
measure: Change from Baseline in Distance Activity Subscale as Assessed by NEI VFQ-25 up to Month 60
timeFrame: Baseline up to Month 60
measure: Change from Baseline in Composite Scores as Assessed by NEI VFQ-25 up to Month 60
timeFrame: Baseline up to Month 60
measure: Change from Baseline in Functional Reading Independence Score up to Month 60
timeFrame: Baseline up to Month 60
measure: Percentage of Participants With Medical Events
timeFrame: Baseline up to Month 60
measure: Percentage of Participants With Ocular Events
timeFrame: Baseline up to Month 60
Other outcomes:
Locations:
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Chesterfield
country: United States
facility: Midwest Vision Research Foundation
state: Missouri
city: Charlotte
country: United States
facility: Char Eye Ear &Throat Assoc
state: North Carolina
city: Cleveland
country: United States
facility: Retina Assoc of Cleveland Inc
state: Ohio
city: Florence
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Retina PC.
state: Tennessee
city: Abilene
country: United States
facility: Retina Res Institute of Texas
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Morgantown
country: United States
facility: West Virginia University Eye Institute
state: West 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: Mendoza
country: Argentina
facility: Oftar
city: Parramatta
country: Australia
facility: Marsden Eye Research Centre
state: New South Wales
city: Adelaide
country: Australia
facility: Adelaide Eye and Retina Centre
state: South Australia
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: Sao Paulo
country: Brazil
facility: Instituto da Visão IPEPO
state: SP
city: Sao Paulo
country: Brazil
facility: Hosp Clinicas da FMUSP
state: SP
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Halifax
country: Canada
facility: QEII - HSC Department of Ophthalmology
state: Nova Scotia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network Toronto Western Hospital
state: Ontario
city: Boisbriand
country: Canada
facility: Institut De L'Oeil Des Laurentides
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Maisonneuve - Rosemont
state: Quebec
city: Creteil
country: France
facility: Chi De Creteil; Ophtalmologie
city: Dijon
country: France
facility: CHU Bocage; Ophtalmologie
city: Lyon cedex
country: France
facility: Hopital de la croix rousse; Ophtalmologie
city: Marseille
country: France
facility: Centre Paradis Monticelli; Ophtalmologie
city: Paris
country: France
facility: Centre Odeon; Exploration Ophtalmologique
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: Bonn
country: Germany
facility: Universitäts-Augenklinik Bonn
city: Köln
country: Germany
facility: Universitätsklinikum Köln; Augenklinik
city: Münster
country: Germany
facility: Universitätsklinikum Münster; Augenheilkunde
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
city: Budapest
country: Hungary
facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK, Szemeszeti Klinika
city: Budapest
country: Hungary
facility: Budapest Retina Associates Kft.
city: Debrecem
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
city: Pecs
country: Hungary
facility: Ganglion Medial Center
city: Roma
country: Italy
facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
state: Lazio
city: Milano
country: Italy
facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
state: Lombardia
city: Bydgoszcz
country: Poland
facility: OFTALMIKA Sp. z o.o
city: Bytom
country: Poland
facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki
city: Gdańsk
country: Poland
facility: Optimum Profesorskie Centrum Okulistyki
city: Katowice
country: Poland
facility: Gabinet Okulistyczny Prof Edward Wylegala
city: Krakow
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
city: Wroclaw
country: Poland
facility: SPEKTRUM Osrodek Okulistyki Klinicznej
city: Łódź
country: Poland
facility: Klinika Okulistyczna Jasne Błonia
city: Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge; Servicio de Oftalmologia
state: Barcelona
city: San Cugat Del Valles
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia
state: Navarra
city: Barcelona
country: Spain
facility: Institut de la Macula i la retina
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
city: Southhampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: