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

Primary Purpose

Geographic Atrophy

Status
Terminated
Phase
Locations
International
Study Type
Observational
Intervention
No intervention
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Geographic Atrophy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina Specialty Institute
  • Midwest Vision Research Foundation
  • Char Eye Ear &Throat Assoc
  • Retina Assoc of Cleveland Inc
  • Palmetto Retina Center
  • Tennessee Retina PC.
  • Retina Res Institute of Texas
  • Texas Retina Associates
  • Retina Consultants of Houston
  • Strategic Clinical Research Group, LLC
  • West Virginia University Eye Institute
  • Organizacion Medica de Investigacion
  • Oftalmos
  • Centro Privado de Ojos Romagosa
  • Onnis Instituto oftalmológico privado
  • Oftar
  • Marsden Eye Research Centre
  • Adelaide Eye and Retina Centre
  • Royal Victorian Eye and Ear Hospital
  • The Lions Eye Institute
  • Instituto da Visão IPEPO
  • Hosp Clinicas da FMUSP
  • University of British Columbia
  • QEII - HSC Department of Ophthalmology
  • Sunnybrook Health Sciences Centre
  • University Health Network Toronto Western Hospital
  • Institut De L'Oeil Des Laurentides
  • Hôpital Maisonneuve - Rosemont
  • Chi De Creteil; Ophtalmologie
  • CHU Bocage; Ophtalmologie
  • Hopital de la croix rousse; Ophtalmologie
  • Centre Paradis Monticelli; Ophtalmologie
  • Centre Odeon; Exploration Ophtalmologique
  • Hopital Lariboisiere; Ophtalmologie
  • CHNO des Quinze Vingts; Ophtalmologie
  • CHU Poitiers - CHR La Miletrie; Ophtalmologie
  • Centres Ophtalmologique St Exupéry; Ophtalmologie
  • Universitäts-Augenklinik Bonn
  • Universitätsklinikum Köln; Augenklinik
  • Universitätsklinikum Münster; Augenheilkunde
  • Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
  • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
  • Semmelweis Egyetem AOK, Szemeszeti Klinika
  • Budapest Retina Associates Kft.
  • Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
  • Ganglion Medial Center
  • Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
  • ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
  • OFTALMIKA Sp. z o.o
  • Szpital Specjalistyczny nr 1; Oddzial Okulistyki
  • Optimum Profesorskie Centrum Okulistyki
  • Gabinet Okulistyczny Prof Edward Wylegala
  • SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
  • SPEKTRUM Osrodek Okulistyki Klinicznej
  • Klinika Okulistyczna Jasne Błonia
  • Hospital Universitari de Bellvitge; Servicio de Oftalmologia
  • Hospital General de Catalunya
  • Clinica Universitaria de Navarra; Servicio de Oftalmologia
  • Institut de la Macula i la retina
  • Bradford Royal Infirmary
  • Bristol Eye Hospital
  • Moorfields Eye Hospital NHS Foundation Trust
  • University Hospital Southampton NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Arm Label

Geographic Atrophy Participants

Arm Description

Participants 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart up to Month 60
Change from Baseline in BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions up to Month 60
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
Change from Baseline in Monocular Reading Speed as Assessed by MNRead Cards or Radner Reading Cards up to Month 60
Change from Baseline in Binocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60
Change from Baseline in Monocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60
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
Change from Baseline in Distance Activity Subscale as Assessed by NEI VFQ-25 up to Month 60
Change from Baseline in Composite Scores as Assessed by NEI VFQ-25 up to Month 60
Change from Baseline in Functional Reading Independence Score up to Month 60
Percentage of Participants With Medical Events
Percentage of Participants With Ocular Events

Full Information

First Posted
March 23, 2015
Last Updated
August 7, 2019
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02399072
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
There is no longer a plan to pursue an approval of lampalizumab.
Study Start Date
March 30, 2015 (Actual)
Primary Completion Date
February 8, 2018 (Actual)
Study Completion Date
February 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy

7. Study Design

Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Geographic Atrophy Participants
Arm Description
Participants 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.
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
No intervention administered in this study
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart up to Month 60
Time Frame
Baseline up to Month 60
Title
Change from Baseline in BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions up to Month 60
Time Frame
Baseline up to Month 60
Title
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
Time Frame
Baseline up to Month 60
Title
Change from Baseline in Monocular Reading Speed as Assessed by MNRead Cards or Radner Reading Cards up to Month 60
Time Frame
Baseline up to Month 60
Title
Change from Baseline in Binocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60
Time Frame
Baseline up to Month 60
Title
Change from Baseline in Monocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60
Time Frame
Baseline up to Month 60
Title
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
Time Frame
Baseline up to Month 60
Title
Change from Baseline in Distance Activity Subscale as Assessed by NEI VFQ-25 up to Month 60
Time Frame
Baseline up to Month 60
Title
Change from Baseline in Composite Scores as Assessed by NEI VFQ-25 up to Month 60
Time Frame
Baseline up to Month 60
Title
Change from Baseline in Functional Reading Independence Score up to Month 60
Time Frame
Baseline up to Month 60
Title
Percentage of Participants With Medical Events
Time Frame
Baseline up to Month 60
Title
Percentage of Participants With Ocular Events
Time Frame
Baseline up to Month 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Midwest Vision Research Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Char Eye Ear &Throat Assoc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Retina Assoc of Cleveland Inc
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Palmetto Retina Center
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Tennessee Retina PC.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Retina Res Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Retina Consultants of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Strategic Clinical Research Group, LLC
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Facility Name
West Virginia University Eye Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Organizacion Medica de Investigacion
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Oftalmos
City
Capital Federal
ZIP/Postal Code
C1120AAN
Country
Argentina
Facility Name
Centro Privado de Ojos Romagosa
City
Cordoba
Country
Argentina
Facility Name
Onnis Instituto oftalmológico privado
City
Cordoba
Country
Argentina
Facility Name
Oftar
City
Mendoza
ZIP/Postal Code
M5500GGK
Country
Argentina
Facility Name
Marsden Eye Research Centre
City
Parramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Adelaide Eye and Retina Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Victorian Eye and Ear Hospital
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
The Lions Eye Institute
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Instituto da Visão IPEPO
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04038-032
Country
Brazil
Facility Name
Hosp Clinicas da FMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z4
Country
Canada
Facility Name
QEII - HSC Department of Ophthalmology
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Institut De L'Oeil Des Laurentides
City
Boisbriand
State/Province
Quebec
ZIP/Postal Code
J7H 1S6
Country
Canada
Facility Name
Hôpital Maisonneuve - Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Chi De Creteil; Ophtalmologie
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU Bocage; Ophtalmologie
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hopital de la croix rousse; Ophtalmologie
City
Lyon cedex
ZIP/Postal Code
69317
Country
France
Facility Name
Centre Paradis Monticelli; Ophtalmologie
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Centre Odeon; Exploration Ophtalmologique
City
Paris
ZIP/Postal Code
75006
Country
France
Facility Name
Hopital Lariboisiere; Ophtalmologie
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CHNO des Quinze Vingts; Ophtalmologie
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
CHU Poitiers - CHR La Miletrie; Ophtalmologie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centres Ophtalmologique St Exupéry; Ophtalmologie
City
St Cyr Sur Loire
ZIP/Postal Code
37540
Country
France
Facility Name
Universitäts-Augenklinik Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitätsklinikum Köln; Augenklinik
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Münster; Augenheilkunde
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Semmelweis Egyetem AOK, Szemeszeti Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Budapest Retina Associates Kft.
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
City
Debrecem
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Ganglion Medial Center
City
Pecs
ZIP/Postal Code
7621
Country
Hungary
Facility Name
Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
Facility Name
OFTALMIKA Sp. z o.o
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
Facility Name
Szpital Specjalistyczny nr 1; Oddzial Okulistyki
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Optimum Profesorskie Centrum Okulistyki
City
Gdańsk
ZIP/Postal Code
80-809
Country
Poland
Facility Name
Gabinet Okulistyczny Prof Edward Wylegala
City
Katowice
ZIP/Postal Code
40-594
Country
Poland
Facility Name
SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
SPEKTRUM Osrodek Okulistyki Klinicznej
City
Wroclaw
ZIP/Postal Code
53-334
Country
Poland
Facility Name
Klinika Okulistyczna Jasne Błonia
City
Łódź
ZIP/Postal Code
91-134
Country
Poland
Facility Name
Hospital Universitari de Bellvitge; Servicio de Oftalmologia
City
Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Hospital General de Catalunya
City
San Cugat Del Valles
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Clinica Universitaria de Navarra; Servicio de Oftalmologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Institut de la Macula i la retina
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Bristol Eye Hospital
City
Bristol
ZIP/Postal Code
BS1 2LX
Country
United Kingdom
Facility Name
Moorfields Eye Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southhampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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