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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03894020




Registration number
NCT03894020
Ethics application status
Date submitted
22/03/2019
Date registered
28/03/2019
Date last updated
16/09/2020

Titles & IDs
Public title
GTSCOPE - To Evaluate the Natural Progression of Dry Age-related Macular Degeneration (AMD)
Scientific title
A Study of Disease Progression in Genetically Defined Subjects With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Secondary ID [1] 0 0
GTSCOPE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Age-related Macular Degeneration 0 0
Macular Degeneration 0 0
Retinal Disease 0 0
Retinal Degeneration 0 0
Geographic Atrophy 0 0
Macular Atrophy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Geographic Atrophy (GA) - Change from baseline in area of Geographic Atrophy, as assessed by Fundus Auto Fluoresence measured in mm2
Timepoint [1] 0 0
Up to 96 weeks
Primary outcome [2] 0 0
Colour Fundus (CF) - Change from baseline in Colour Fundus Photography measured in mm2
Timepoint [2] 0 0
Up to 96 weeks
Primary outcome [3] 0 0
Retinal Drusen Volume - Change from baseline in retinal drusen volume measured in mm3
Timepoint [3] 0 0
Up to 96 weeks
Primary outcome [4] 0 0
Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) - Change from baseline in ETDRS BCVA reading score
Timepoint [4] 0 0
Up to 96 weeks
Primary outcome [5] 0 0
Retinal sensitivity - Change from baseline in retinal sensitivity as assessed by microperimetry
Timepoint [5] 0 0
Up to 96 weeks
Primary outcome [6] 0 0
Visual Functioning Questionnaire - Change from baseline in National Eye Institute Visual Functioning Questionnaire 25-Items Version (NEI VFQ-25) Minimum Score (Best) = 29. Maximum score (Worst) = 149
Timepoint [6] 0 0
Up to 96 weeks
Primary outcome [7] 0 0
Medical Events of Interest (MEI) - Change from baseline in percentage of Participants with MEI
Timepoint [7] 0 0
Up to 96 weeks
Primary outcome [8] 0 0
Monocular and Binocular Reading Performance - Change in Monocular and Binocular Reading Performance measured in words/min
Timepoint [8] 0 0
Up to 96 weeks

Eligibility
Key inclusion criteria
1. Adults with unilateral or bilateral Geographic Atrophy (GA) due to Age-related Macular
Degeneration (AMD)

2. BCVA of 40 letters or better using ETDRS charts
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Evidence or history of neovascular Age-related Macular Degeneration (AMD) or diabetic
retinopathy

2. Significant ocular or non-ocular disease that would impact the subject's ability to
participate in the study

3. 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The University of Melbourne - The Centre for Eye Research Australia (CERA) - East Melbourne
Recruitment hospital [2] 0 0
Lions Eye Institute (LEI) - Nedlands - Nedlands
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
West Virginia
Country [21] 0 0
France
State/province [21] 0 0
Bordeaux
Country [22] 0 0
France
State/province [22] 0 0
Créteil
Country [23] 0 0
France
State/province [23] 0 0
Dijon
Country [24] 0 0
France
State/province [24] 0 0
Lyon
Country [25] 0 0
France
State/province [25] 0 0
Marseille
Country [26] 0 0
France
State/province [26] 0 0
Nantes
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Poitiers
Country [29] 0 0
Germany
State/province [29] 0 0
Hamburg
Country [30] 0 0
Germany
State/province [30] 0 0
Lübeck
Country [31] 0 0
Germany
State/province [31] 0 0
Munich
Country [32] 0 0
Germany
State/province [32] 0 0
Münster
Country [33] 0 0
Germany
State/province [33] 0 0
Sulzbach
Country [34] 0 0
Germany
State/province [34] 0 0
Tübingen
Country [35] 0 0
Netherlands
State/province [35] 0 0
Nijmegen
Country [36] 0 0
Poland
State/province [36] 0 0
Rojna
Country [37] 0 0
Poland
State/province [37] 0 0
Bydgoszcz
Country [38] 0 0
Poland
State/province [38] 0 0
Tarnowskie Góry
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Spain
State/province [41] 0 0
Pamplona
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Wiltshire
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Glasgow
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Leeds
Country [45] 0 0
United Kingdom
State/province [45] 0 0
London
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Manchester
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Oxford
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Sunderland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gyroscope Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
An observational study to evaluate the natural progression of dry AMD in genetically defined
subjects
Trial website
https://clinicaltrials.gov/show/NCT03894020
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gyroscope Therapeutics
Address 0 0
Country 0 0
Phone 0 0
+441438532142
Fax 0 0
Email 0 0
clinicaltrials@gyroscopetx.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03894020