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

Geographic Atrophy Clinical Trial

Official title:

A Multicenter, Prospective Epidemiologic Study of the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02399072
• Other study ID #: GX29639
• Secondary ID: 2014-003940-11GX
• Status: Terminated
• Start date: March 30, 2015
• Est. completion date: February 8, 2018

Study information

• Verified date: August 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 202
• Est. completion date: February 8, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Other:
• No intervention
No intervention administered in this study

Locations

Country	Name	City	State
Argentina	Organizacion Medica de Investigacion	Buenos Aires
Argentina	Oftalmos	Capital Federal
Argentina	Centro Privado de Ojos Romagosa	Cordoba
Argentina	Onnis Instituto oftalmológico privado	Cordoba
Argentina	Oftar	Mendoza
Australia	Adelaide Eye and Retina Centre	Adelaide	South Australia
Australia	Royal Victorian Eye and Ear Hospital	East Melbourne	Victoria
Australia	The Lions Eye Institute	Nedlands	Western Australia
Australia	Marsden Eye Research Centre	Parramatta	New South Wales
Brazil	Hosp Clinicas da FMUSP	Sao Paulo	SP
Brazil	Instituto da Visão IPEPO	Sao Paulo	SP
Canada	Institut De L'Oeil Des Laurentides	Boisbriand	Quebec
Canada	QEII - HSC Department of Ophthalmology	Halifax	Nova Scotia
Canada	Hôpital Maisonneuve - Rosemont	Montreal	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network Toronto Western Hospital	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
France	Chi De Creteil; Ophtalmologie	Creteil
France	CHU Bocage; Ophtalmologie	Dijon
France	Hopital de la croix rousse; Ophtalmologie	Lyon cedex
France	Centre Paradis Monticelli; Ophtalmologie	Marseille
France	Centre Odeon; Exploration Ophtalmologique	Paris
France	CHNO des Quinze Vingts; Ophtalmologie	Paris
France	Hopital Lariboisiere; Ophtalmologie	Paris
France	CHU Poitiers - CHR La Miletrie; Ophtalmologie	Poitiers
France	Centres Ophtalmologique St Exupéry; Ophtalmologie	St Cyr Sur Loire
Germany	Universitäts-Augenklinik Bonn	Bonn
Germany	Universitätsklinikum Köln; Augenklinik	Köln
Germany	Universitätsklinikum Münster; Augenheilkunde	Münster
Germany	Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde	Regensburg
Hungary	Budapest Retina Associates Kft.	Budapest
Hungary	Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR	Budapest
Hungary	Semmelweis Egyetem AOK, Szemeszeti Klinika	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika	Debrecem
Hungary	Ganglion Medial Center	Pecs
Italy	ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)	Milano	Lombardia
Italy	Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche	Roma	Lazio
Poland	OFTALMIKA Sp. z o.o	Bydgoszcz
Poland	Szpital Specjalistyczny nr 1; Oddzial Okulistyki	Bytom
Poland	Optimum Profesorskie Centrum Okulistyki	Gdansk
Poland	Gabinet Okulistyczny Prof Edward Wylegala	Katowice
Poland	SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Okulistyki i Onkologii Okulistycznej	Krakow
Poland	Klinika Okulistyczna Jasne Blonia	Lódz
Poland	SPEKTRUM Osrodek Okulistyki Klinicznej	Wroclaw
Spain	Institut de la Macula i la retina	Barcelona
Spain	Hospital Universitari de Bellvitge; Servicio de Oftalmologia	Hospitalet De Llobregat	Barcelona
Spain	Clinica Universitaria de Navarra; Servicio de Oftalmologia	Pamplona	Navarra
Spain	Hospital General de Catalunya	San Cugat Del Valles	Barcelona
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	Bristol Eye Hospital	Bristol
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust	London
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southhampton
United States	Retina Res Institute of Texas	Abilene	Texas
United States	Char Eye Ear &Throat Assoc	Charlotte	North Carolina
United States	Midwest Vision Research Foundation	Chesterfield	Missouri
United States	Retina Assoc of Cleveland Inc	Cleveland	Ohio
United States	Texas Retina Associates	Dallas	Texas
United States	Palmetto Retina Center	Florence	South Carolina
United States	West Virginia University Eye Institute	Morgantown	West Virginia
United States	Tennessee Retina PC.	Nashville	Tennessee
United States	Retina Specialty Institute	Pensacola	Florida
United States	Retina Consultants of Houston	The Woodlands	Texas
United States	Strategic Clinical Research Group, LLC	Willow Park	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  France,  Germany,  Hungary,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change from Baseline in the GA Area as Assessed by Fundus Autofluorescence (FAF) up to Month 60		Baseline up to Month 60
Secondary	Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart up to Month 60		Baseline up to Month 60
Secondary	Change from Baseline in BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions up to Month 60		Baseline up to Month 60
Secondary	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		Baseline up to Month 60
Secondary	Change from Baseline in Monocular Reading Speed as Assessed by MNRead Cards or Radner Reading Cards up to Month 60		Baseline up to Month 60
Secondary	Change from Baseline in Binocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60		Baseline up to Month 60
Secondary	Change from Baseline in Monocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60		Baseline up to Month 60
Secondary	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		Baseline up to Month 60
Secondary	Change from Baseline in Distance Activity Subscale as Assessed by NEI VFQ-25 up to Month 60		Baseline up to Month 60
Secondary	Change from Baseline in Composite Scores as Assessed by NEI VFQ-25 up to Month 60		Baseline up to Month 60
Secondary	Change from Baseline in Functional Reading Independence Score up to Month 60		Baseline up to Month 60
Secondary	Percentage of Participants With Medical Events		Baseline up to Month 60
Secondary	Percentage of Participants With Ocular Events		Baseline up to Month 60