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

Geographic Atrophy Clinical Trial

— Proxima A  

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: NCT02479386
• Other study ID #: GX29633
• Secondary ID: 2014-003939-19GX
• Status: Terminated
• Start date: June 24, 2015
• Est. completion date: January 31, 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 296
• Est. completion date: January 31, 2018
• Est. primary completion date: April 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Other:
• No intervention
No intervention was 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	Clinica Privada de Ojos	Mar del Plata
Argentina	Centro Oftalmólogos Especialistas	Rosario
Australia	Royal Victorian Eye and Ear Hospital	East Melbourne	Victoria
Australia	Northern Beaches Retina Cataract Glaucoma	Mona Vale	New South Wales
Australia	The Lions Eye Institute	Nedlands	Western Australia
Australia	Strathfield Retina Clinic	Strathfield	New South Wales
Australia	Newcastle Eye Hospital Research Foundation	Waratah	New South Wales
Austria	Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie	Wien
Brazil	Hospital de Olhos de Aparecida - HOA	Aparecida de Goiania	GO
Brazil	Instituto da Visão	Belo Horizonte	MG
Brazil	Botelho Hospital da Visao	Blumenau	SC
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	Calgary Retina Consultants	Calgary	Alberta
France	Chi De Creteil; Ophtalmologie	Creteil
France	Clinique de la Louviere - Nord retine; Maladie et chirurgie des Yeux	Lille
France	Centre ophtalmologique Rabelais; Ophtalmologie	Lyon
France	Centre Paradis Monticelli; Ophtalmologie	Marseille
France	CHNO des Quinze Vingts; Ophtalmologie	Paris
France	Hopital Lariboisiere; Ophtalmologie	Paris
France	Fondation Rothschild; Ophtalmologie	Paris Cedex 19
France	CHU Poitiers - CHR La Miletrie; Ophtalmologie	Poitiers
France	Centres Ophtalmologique St Exupéry; Ophtalmologie	St Cyr Sur Loire
France	Cabinet La Maison Rouge; Ophtalmologie	Strasbourg
Germany	Universitatsklinikum Leipzig	Leipzig
Germany	Klinikum rechts der Isar der TU München; Augenklinik	München
Germany	Universitätsklinikum Tübingen	Tuebingen
Greece	University General Hospital of Heraklion; Department of Ophthalmology	Heraklion
Greece	European Interbalkan Medical Center; Ophthalmology Dpt	Thessaloniki
Hungary	Bajcsy-Zsilinszky Hospital	Budapest
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely	Budapest
Hungary	Kenezy Gyula Korhaz; Szemeszet	Debrecen
Hungary	Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET	Szombathely
Israel	Soroka university medical center; Ophtalmology	Beer Sheva
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah MC; Ophtalmology	Jerusalem
Israel	Meir Medical Center; Ophtalmology	Kfar Saba
Israel	Rabin Medical Center	Petach Tikva
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center; Ophtalmology	Rehovot
Israel	Tel Aviv Sourasky MC; Ophtalmology	Tel Aviv
Italy	Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica	Firenze	Toscana
Italy	ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)	Milano	Lombardia
Italy	Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche	Napoli	Campania
Italy	Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica	Negrar - Verona	Veneto
Italy	Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria	Pisa	Toscana
Italy	Università degli Studi dell'Insubria; Clinica Oculistica	Varese	Lombardia
Poland	Klinika Okulistyki Ogolnej w Lublinie	Lublin
Poland	Pomorski Uniwersytet Medyczny w Szczecinie, Zaklad Patologii Ogolnej PUM"	Szczecin
Poland	SPEKTRUM Osrodek Okulistyki Klinicznej	Wroclaw
Spain	Hospital de la Santa Creu i Sant Pau; Servicio de Oftalmologia	Barcelona
Spain	Institut de la Macula i la retina	Barcelona
Spain	Clinica Doctores Piñero; Oftalmologia	Sevilla
Spain	Hospital Universitario Virgen de la Macarena; Servicio de Oftalmologia	Sevilla
Spain	Hospital Clinico Universitario de Valladolid; Servicio de oftalmologia	Valladolid
Spain	Hospital Universitario Rio Hortega; Servicio de Oftalmologia	Valladolid
United Kingdom	Bristol Eye Hospital	Bristol
United Kingdom	Kent & Canterbury Hospital	Canterbury
United Kingdom	Hull and East Yorkshire Eye Hospital	Hull
United Kingdom	John Radcliffe Hospital; Oxford Eye Hospital	Oxford
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southhampton
United Kingdom	Sunderland Eye Infirmary	Sunderland
United Kingdom	Pinderfields Hospital; Clinical Research Team, Rowan House	Wakefield
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Retinal Diagnostic Center	Campbell	California
United States	University of North Carolina; Kittner Eye Center	Chapel Hill	North Carolina
United States	Char Eye Ear &Throat Assoc	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Rand Eye	Deerfield Beach	Florida
United States	Duke University Eye Center; Vitreoretinal	Durham	North Carolina
United States	Palmetto Retina Center	Florence	South Carolina
United States	Specialty Eye Care Medical Center	Glendale	California
United States	Colorado Retina Associates, PC	Golden	Colorado
United States	Foundation for Vision Research	Grand Rapids	Michigan
United States	Retina Consultants of Houston	Houston	Texas
United States	Jules Stein Eye Institute/ UCLA	Los Angeles	California
United States	Bascom Palmer Eye Institute	Naples	Florida
United States	MaculaCare, PLLC	New York	New York
United States	Vitreous-Retina-Macula	New York	New York
United States	Wagner Macula & Retina Center	Norfolk	Virginia
United States	East Bay Retina Consultants	Oakland	California
United States	Paducah Retinal Center	Paducah	Kentucky
United States	Scheie Eye Institute	Philadelphia	Pennsylvania
United States	Med Center Ophthalmology Assoc	San Antonio	Texas
United States	Center For Sight	Sarasota	Florida
United States	Northwest Arkansas Retina Associates	Springdale	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Scotomatous Points as Assessed by Mesopic Microperimetry (MP)		Baseline up to end of study (up to approximately 48 months)
Primary	Macular Sensitivity as Assessed by Mesopic MP		Baseline up to end of study (up to approximately 48 months)
Primary	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)
Primary	BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions		Baseline up to end of study (up to approximately 48 months)
Primary	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)
Primary	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	Change from Baseline in the GA area, as Assessed by Fundus Autofluorescence (FAF)		Baseline, end of study (up to approximately 48 months)
Secondary	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)
Secondary	Change from Baseline in Functional Reading Independence (FRI) Index Score		Baseline, end of study (up to approximately 48 months)
Secondary	Percentage of Participants With Medical Events of Interest (MEIs)	The clinical events (cardiovascular, respiratory, cognitive, ocular events etc.) occurring during the study are termed as MEIs. These events will be collected using MEI electronic Case Report Form (eCRF) checklist.	Baseline up to end of study (up to approximately 48 months)