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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Terminated
CT.gov ID
NCT02479386
Collaborator
(none)
296
Enrollment
91
Locations
31.3
Actual Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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 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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Actual Enrollment :
296 participants
Official Title:
A Multicenter, Prospective Epidemiologic Study of The Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration
Actual Study Start Date :
Jun 24, 2015
Actual Primary Completion Date :
Apr 14, 2017
Actual Study Completion Date :
Jan 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Cohort Geographic Atrophy

Cohort of participants with GA secondary to AMD will be evaluated for changes in GA over time.

Other: No intervention
No intervention was administered in this study.

Outcome Measures

Primary Outcome Measures

  1. Number of Scotomatous Points as Assessed by Mesopic Microperimetry (MP) [Baseline up to end of study (up to approximately 48 months)]

  2. Macular Sensitivity as Assessed by Mesopic MP [Baseline up to end of study (up to approximately 48 months)]

  3. 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)]

  4. BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions [Baseline up to end of study (up to approximately 48 months)]

  5. 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)]

  6. 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 Outcome Measures

  1. Change from Baseline in the GA area, as Assessed by Fundus Autofluorescence (FAF) [Baseline, end of study (up to approximately 48 months)]

  2. 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)]

  3. Change from Baseline in Functional Reading Independence (FRI) Index Score [Baseline, end of study (up to approximately 48 months)]

  4. Percentage of Participants With Medical Events of Interest (MEIs) [Baseline up to end of study (up to approximately 48 months)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwest Arkansas Retina Associates Springdale Arkansas United States 72764
2 Retinal Diagnostic Center Campbell California United States 95008
3 Specialty Eye Care Medical Center Glendale California United States 91203
4 Jules Stein Eye Institute/ UCLA Los Angeles California United States 90095-7000
5 East Bay Retina Consultants Oakland California United States 94609
6 Colorado Retina Associates, PC Golden Colorado United States 80401
7 Rand Eye Deerfield Beach Florida United States 33064
8 Bascom Palmer Eye Institute Naples Florida United States 34103
9 Center For Sight Sarasota Florida United States 34239
10 Rush University Medical Center Chicago Illinois United States 60612
11 Paducah Retinal Center Paducah Kentucky United States 42001
12 Greater Baltimore Medical Center Baltimore Maryland United States 21204
13 Foundation for Vision Research Grand Rapids Michigan United States 49546
14 MaculaCare, PLLC New York New York United States 10021
15 Vitreous-Retina-Macula New York New York United States 10022
16 University of North Carolina; Kittner Eye Center Chapel Hill North Carolina United States 27517
17 Char Eye Ear &Throat Assoc Charlotte North Carolina United States 28210
18 Duke University Eye Center; Vitreoretinal Durham North Carolina United States 27710
19 Scheie Eye Institute Philadelphia Pennsylvania United States 19104
20 Palmetto Retina Center Florence South Carolina United States 29501
21 Retina Consultants of Houston Houston Texas United States 77030
22 Med Center Ophthalmology Assoc San Antonio Texas United States 78240
23 Wagner Macula & Retina Center Norfolk Virginia United States 23451
24 Organizacion Medica de Investigacion Buenos Aires Argentina C1015ABO
25 Oftalmos Capital Federal Argentina C1120AAN
26 Centro Privado de Ojos Romagosa Cordoba Argentina
27 Onnis Instituto oftalmológico privado Cordoba Argentina
28 Clinica Privada de Ojos Mar del Plata Argentina B7600DFC
29 Centro Oftalmólogos Especialistas Rosario Argentina S2000ANJ
30 Northern Beaches Retina Cataract Glaucoma Mona Vale New South Wales Australia 2103
31 Strathfield Retina Clinic Strathfield New South Wales Australia 2135
32 Newcastle Eye Hospital Research Foundation Waratah New South Wales Australia 2298
33 Royal Victorian Eye and Ear Hospital East Melbourne Victoria Australia 3002
34 The Lions Eye Institute Nedlands Western Australia Australia 6009
35 Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie Wien Austria 1090
36 Hospital de Olhos de Aparecida - HOA Aparecida de Goiania GO Brazil 74980-010
37 Instituto da Visão Belo Horizonte MG Brazil 30150-270
38 Botelho Hospital da Visao Blumenau SC Brazil 89052-504
39 Instituto da Visão IPEPO Sao Paulo SP Brazil 04038-032
40 Hosp Clinicas da FMUSP Sao Paulo SP Brazil 05403-000
41 Calgary Retina Consultants Calgary Alberta Canada T2J 0C8
42 Institut De L'Oeil Des Laurentides Boisbriand Quebec Canada J7H 1S6
43 Chi De Creteil; Ophtalmologie Creteil France 94010
44 Clinique de la Louviere - Nord retine; Maladie et chirurgie des Yeux Lille France 59000
45 Centre ophtalmologique Rabelais; Ophtalmologie Lyon France 69003
46 Centre Paradis Monticelli; Ophtalmologie Marseille France 13008
47 Fondation Rothschild; Ophtalmologie Paris Cedex 19 France 75940
48 Hopital Lariboisiere; Ophtalmologie Paris France 75010
49 CHNO des Quinze Vingts; Ophtalmologie Paris France 75012
50 CHU Poitiers - CHR La Miletrie; Ophtalmologie Poitiers France 86021
51 Centres Ophtalmologique St Exupéry; Ophtalmologie St Cyr Sur Loire France 37540
52 Cabinet La Maison Rouge; Ophtalmologie Strasbourg France 67000
53 Universitatsklinikum Leipzig Leipzig Germany 04103
54 Klinikum rechts der Isar der TU München; Augenklinik München Germany 81675
55 Universitätsklinikum Tübingen Tuebingen Germany 72076
56 University General Hospital of Heraklion; Department of Ophthalmology Heraklion Greece 711 10
57 European Interbalkan Medical Center; Ophthalmology Dpt Thessaloniki Greece 57001
58 Bajcsy-Zsilinszky Hospital Budapest Hungary 1106
59 Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely Budapest Hungary H-1077
60 Kenezy Gyula Korhaz; Szemeszet Debrecen Hungary 4031
61 Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET Szombathely Hungary 9700
62 Soroka university medical center; Ophtalmology Beer Sheva Israel 8489501
63 Rambam Health Care Campus Haifa Israel 3109600
64 Hadassah MC; Ophtalmology Jerusalem Israel 9112001
65 Meir Medical Center; Ophtalmology Kfar Saba Israel 4428164
66 Rabin Medical Center Petach Tikva Israel 49100
67 Chaim Sheba Medical Center Ramat Gan Israel 5265601
68 Kaplan Medical Center; Ophtalmology Rehovot Israel 7660101
69 Tel Aviv Sourasky MC; Ophtalmology Tel Aviv Israel 6423906
70 Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche Napoli Campania Italy 80131
71 ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco) Milano Lombardia Italy 20157
72 Università degli Studi dell'Insubria; Clinica Oculistica Varese Lombardia Italy 21100
73 Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica Firenze Toscana Italy 50134
74 Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria Pisa Toscana Italy 56124
75 Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica Negrar - Verona Veneto Italy 37024
76 Klinika Okulistyki Ogolnej w Lublinie Lublin Poland 20-079
77 Pomorski Uniwersytet Medyczny w Szczecinie, Zaklad Patologii Ogolnej PUM" Szczecin Poland 70-111
78 SPEKTRUM Osrodek Okulistyki Klinicznej Wroclaw Poland 53-334
79 Institut de la Macula i la retina Barcelona Spain 08022
80 Hospital de la Santa Creu i Sant Pau; Servicio de Oftalmologia Barcelona Spain 8025
81 Hospital Universitario Virgen de la Macarena; Servicio de Oftalmologia Sevilla Spain 41007
82 Clinica Doctores Piñero; Oftalmologia Sevilla Spain 41013
83 Hospital Clinico Universitario de Valladolid; Servicio de oftalmologia Valladolid Spain 47005
84 Hospital Universitario Rio Hortega; Servicio de Oftalmologia Valladolid Spain 47012
85 Bristol Eye Hospital Bristol United Kingdom BS1 2LX
86 Kent & Canterbury Hospital Canterbury United Kingdom CT1 3NG
87 Hull and East Yorkshire Eye Hospital Hull United Kingdom HU32J
88 John Radcliffe Hospital; Oxford Eye Hospital Oxford United Kingdom OX3 9DU
89 University Hospital Southampton NHS Foundation Trust Southhampton United Kingdom SO16 6YD
90 Sunderland Eye Infirmary Sunderland United Kingdom SR2 9HP
91 Pinderfields Hospital; Clinical Research Team, Rowan House Wakefield United Kingdom WF1 4DG

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02479386
Other Study ID Numbers:
  • GX29633
  • 2014-003939-19
  • GX29639
First Posted:
Jun 24, 2015
Last Update Posted:
Aug 20, 2019
Last Verified:
Aug 1, 2019
Additional relevant MeSH terms:
Macular Degeneration
Geographic Atrophy
Atrophy

Study Results

No Results Posted as of Aug 20, 2019