GTSCOPE - To Evaluate the Natural Progression of Dry Age-related Macular Degeneration (AMD)
Sponsor
Gyroscope Therapeutics Limited (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03894020
Collaborator
(none)
350
66
48
5.3
0.1
Study Details
Study Description
Brief Summary
An observational study to evaluate the natural progression of dry AMD in genetically defined subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
Prospective, observational study to evaluate the natural progression of anatomical and functional visual parameters in genetically defined subjects with GA due to AMD.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
350 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Study of Disease Progression in Genetically Defined Subjects With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Actual Study Start Date
:
Jan 8, 2019
Anticipated Primary Completion Date
:
Jan 8, 2023
Anticipated Study Completion Date
:
Jan 8, 2023
Outcome Measures
Primary Outcome Measures
- Geographic Atrophy (GA) [Up to 96 weeks]
Change from baseline in area of Geographic Atrophy, as assessed by Fundus Auto Fluoresence measured in mm2
- Colour Fundus (CF) [Up to 96 weeks]
Change from baseline in Colour Fundus Photography measured in mm2
- Retinal Drusen Volume [Up to 96 weeks]
Change from baseline in retinal drusen volume measured in mm3
- Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) [Up to 96 weeks]
Change from baseline in ETDRS BCVA reading score
- Retinal sensitivity [Up to 96 weeks]
Change from baseline in retinal sensitivity as assessed by microperimetry
- Visual Functioning Questionnaire [Up to 96 weeks]
Change from baseline in National Eye Institute Visual Functioning Questionnaire 25-Items Version (NEI VFQ-25) Minimum Score (Best) = 29. Maximum score (Worst) = 149
- Medical Events of Interest (MEI) [Up to 96 weeks]
Change from baseline in percentage of Participants with MEI
- Monocular and Binocular Reading Performance [Up to 96 weeks]
Change in Monocular and Binocular Reading Performance measured in words/min
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Adults with unilateral or bilateral Geographic Atrophy (GA) due to Age-related Macular Degeneration (AMD)
-
BCVA of 40 letters or better using ETDRS charts
Exclusion Criteria:
-
Evidence or history of neovascular Age-related Macular Degeneration (AMD) or diabetic retinopathy
-
Significant ocular or non-ocular disease that would impact the subject's ability to participate in the study
-
Participation in another research study involving an investigational product within the previous 4 weeks or 5 half-lives whichever is longer from the screening/baseline OR received a gene/cell therapy at any time previously
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Retinal Research Institute (retina consultants of AZ) | Phoenix | Arizona | United States | 85053 |
| 2 | Retina Centers PC | Tucson | Arizona | United States | 85704 |
| 3 | Retina Vitreous Associates Medical Group | Beverly Hills | California | United States | 90211 |
| 4 | Retina Health Center | Fort Myers | Florida | United States | 33907 |
| 5 | Southeast Retina Center | Augusta | Georgia | United States | 30909 |
| 6 | Georgia Retina PC | Marietta | Georgia | United States | 30060 |
| 7 | University Retina Macula Associates PC | Lemont | Illinois | United States | 60452 |
| 8 | Midwest Eye Institute Northside | Indianapolis | Indiana | United States | 46290 |
| 9 | Wolfe Eye Clinic | West Des Moines | Iowa | United States | 50266 |
| 10 | Johns Hopkins University School of Medicine | Baltimore | Maryland | United States | 21287 |
| 11 | Ophthalamic Consultants of Boston (OCB) | Boston | Massachusetts | United States | 02114 |
| 12 | Pepose Vision Institute | Chesterfield | Missouri | United States | 63017 |
| 13 | Sierra Eye Associates | Reno | Nevada | United States | 89502 |
| 14 | New Jersey Retina Research Foundation | Vauxhall | New Jersey | United States | 07088 |
| 15 | Long Island Vitreoretinal Consultants | Great Neck | New York | United States | 11021 |
| 16 | Retina Association of Western New York | Rochester | New York | United States | 14620 |
| 17 | Cincinnati Eye Institute | Cincinnati | Ohio | United States | 45227 |
| 18 | Casey Eye Institute - OHSU | Portland | Oregon | United States | 97239 |
| 19 | Eye Clinic | Portland | Oregon | United States | 97239 |
| 20 | Mid-Atlantic Retina | Huntingdon Valley | Pennsylvania | United States | 19107 |
| 21 | Mid-Atlantic Retina | Philadelphia | Pennsylvania | United States | 19107 |
| 22 | The Retina Care Center | Dallas | Texas | United States | 21209 |
| 23 | Retina Foundation of the Southwest | Dallas | Texas | United States | 75231 |
| 24 | Retina Consultants of Houston-TMC | Houston | Texas | United States | 77030 |
| 25 | Strategic Clinical Research | Willow Park | Texas | United States | 76008 |
| 26 | Retina Associates of Utah | Salt Lake City | Utah | United States | 84107 |
| 27 | Retina Center Northwest | Silverdale | Washington | United States | 98383 |
| 28 | Spokane Eye Clinical Research | Spokane | Washington | United States | 99204 |
| 29 | West Virginia University | Morgantown | West Virginia | United States | 26506 |
| 30 | The University of Melbourne - The Centre for Eye Research Australia (CERA) | East Melbourne | Australia | 3002 | |
| 31 | Lions Eye Institute (LEI) - Nedlands | Nedlands | Australia | 6009 | |
| 32 | Centre Ophthalmologique | Bordeaux | France | ||
| 33 | Centre Hospitalier Intercommunal | Créteil | France | 94010 | |
| 34 | CHU Dijon - Hôpital Mitterrand | Dijon | France | 2100 | |
| 35 | Hopital de la Croix Rousse - GH Nord | Lyon | France | 69004 | |
| 36 | Centre Paradis Monticelli | Marseille | France | 13008 | |
| 37 | Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu | Nantes | France | 44093 | |
| 38 | Hopital Lariboisiere | Paris | France | 75010 | |
| 39 | Centre Hospitalier | Poitiers | France | ||
| 40 | Universitaetsklinikum Hamburg-Eppendorf | Hamburg | Germany | 20246 | |
| 41 | University Hospital | Hamburg | Germany | ||
| 42 | University Hospital Schleswig-Holstein - Campus Luebeck | Lübeck | Germany | 23538 | |
| 43 | EyeNet Baden-Wuerttemberg | Munich | Germany | 80339 | |
| 44 | St. Franziskus-Hospital | Münster | Germany | 48145 | |
| 45 | MVZ ADTC Siegburg GmbH | Siegburg | Germany | ||
| 46 | Augenklinik Sulzbach | Sulzbach | Germany | 66280 | |
| 47 | University Hospital | Tübingen | Germany | ||
| 48 | Radboud Universitair Medisch Centrum | Nijmegen | Netherlands | 6525 | |
| 49 | Klinika Okulistyczna Jasne Blonia Sp. z o.o. | Łódź | Rojna | Poland | 91-134 |
| 50 | Specjalistyczny Osrodek Okulistyczny Oculomedica | Bydgoszcz | Poland | 85-316 | |
| 51 | Oftalmika - Prywatna Klinika Okulistyczna | Bydgoszcz | Poland | 85-631 | |
| 52 | Caminomed | Tarnowskie Góry | Poland | 42-600 | |
| 53 | Instituto de microcirugía ocular | Barcelona | Spain | 08035 | |
| 54 | Hospital General de Catalunya Sant Cugat del Valles | Barcelona | Spain | 08915 | |
| 55 | VISSUM Mirasierra | Madrid | Spain | 28035 | |
| 56 | Hospital Clinico San Carlos | Madrid | Spain | 28040 | |
| 57 | Eye Hospital | Madrid | Spain | ||
| 58 | Clinica Universidad de Navarra | Pamplona | Spain | 31008 | |
| 59 | Salisbury NHS Foundation Trust | Salisbury | Wiltshire | United Kingdom | SP2 8BJ |
| 60 | NHS Greater Glasgow and Clyde | Glasgow | United Kingdom | G12 0YN | |
| 61 | Leeds Hospital | Leeds | United Kingdom | LS9 7TF | |
| 62 | London Vision Clinic | London | United Kingdom | W1G 7LA | |
| 63 | Manchester Royal Eye Hospital | Manchester | United Kingdom | M13 9WL | |
| 64 | John Radcliffe Hospital | Oxford | United Kingdom | OX3 9DU | |
| 65 | Southampton General Hospital | Southampton | United Kingdom | SO16 6YD | |
| 66 | Sunderland Eye Infirmary | Sunderland | United Kingdom | SR2 9HP |
Sponsors and Collaborators
- Gyroscope Therapeutics Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Gyroscope Therapeutics Limited
ClinicalTrials.gov Identifier:
NCT03894020
Other Study ID Numbers:
- GTSCOPE
First Posted:
Mar 28, 2019
Last Update Posted:
Feb 24, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: