Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    gtscope
Previous Study | Return to List | Next Study

To Evaluate the Natural Progression of Dry Age-related Macular Degeneration (AMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03894020
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Gyroscope Therapeutics

Tracking Information
First Submitted Date March 22, 2019
First Posted Date March 28, 2019
Last Update Posted Date March 18, 2020
Actual Study Start Date January 8, 2019
Estimated Primary Completion Date January 8, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 28, 2019)
  • Geographic Atrophy (GA) [ Time Frame: Up to 96 weeks ]
    Change from baseline in area of Geographic Atrophy, as assessed by Fundus Auto Fluoresence measured in mm2
  • Colour Fundus (CF) [ Time Frame: Up to 96 weeks ]
    Change from baseline in Colour Fundus Photography measured in mm2
  • Retinal Drusen Volume [ Time Frame: 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) [ Time Frame: Up to 96 weeks ]
    Change from baseline in ETDRS BCVA reading score
  • Retinal sensitivity [ Time Frame: Up to 96 weeks ]
    Change from baseline in retinal sensitivity as assessed by microperimetry
  • Visual Functioning Questionnaire [ Time Frame: 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) [ Time Frame: Up to 96 weeks ]
    Change from baseline in percentage of Participants with MEI
  • Monocular and Binocular Reading Performance [ Time Frame: Up to 96 weeks ]
    Change in Monocular and Binocular Reading Performance measured in words/min
Original Primary Outcome Measures
 (submitted: March 27, 2019)
  • Geographic Atrophy (GA) [ Time Frame: Up to 96 weeks ]
    Change from baseline in area of Geographic Atrophy, as assessed by Fundus AutoFluoresence
  • Colour Fundus (CF) [ Time Frame: Up to 96 weeks ]
    Change from baseline in Colour Fundus Photography
  • Retinal Drusen Volume [ Time Frame: 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) [ Time Frame: Up to 96 weeks ]
    Change from baseline in ETDRS BCVA
  • Retinal sensitivity [ Time Frame: Up to 96 weeks ]
    Change from baseline in retinal sensitivity as assessed by microperimetry
  • Visual Functioning Questionnaire [ Time Frame: Up to 96 weeks ]
    Change in 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) [ Time Frame: Up to 96 weeks ]
    Percentage of Participants with MEI
  • Monocular and Binocular Reading Performance [ Time Frame: Up to 96 weeks ]
    Change in Monocular and Binocular Reading Performance
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title To Evaluate the Natural Progression of Dry Age-related Macular Degeneration (AMD)
Official Title A Study of Disease Progression in Genetically Defined Subjects With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Brief Summary An observational study to evaluate the natural progression of dry AMD in genetically defined subjects
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Saliva Samples, blood samples
Sampling Method Non-Probability Sample
Study Population Secondary care.
Condition
  • Dry Age-related Macular Degeneration
  • Macular Degeneration
  • Retinal Disease
  • Retinal Degeneration
  • Geographic Atrophy
  • Macular Atrophy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 27, 2019)
350
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 8, 2023
Estimated Primary Completion Date January 8, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Gyroscope Therapeutics +441438532142 clinicaltrials@gyroscopetx.com
Contact: Chief Medical Officer Gyroscope Therapeutics
Listed Location Countries Australia,   France,   Germany,   Netherlands,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03894020
Other Study ID Numbers GTSCOPE
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Gyroscope Therapeutics
Study Sponsor Gyroscope Therapeutics
Collaborators Not Provided
Investigators Not Provided
PRS Account Gyroscope Therapeutics
Verification Date March 2020