Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    To Evaluate the Natural Progression of Dry Age-related Macular Degeneration (AMD)
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 : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Gyroscope Therapeutics

Brief Summary:
An observational study to evaluate the natural progression of dry AMD in genetically defined subjects

Condition or disease
Dry Age-related Macular Degeneration Macular Degeneration Retinal Disease Retinal Degeneration Geographic Atrophy Macular Atrophy

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.

Layout table for study information
Study Type : Observational
Estimated 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 : January 8, 2019
Estimated Primary Completion Date : January 8, 2023
Estimated Study Completion Date : January 8, 2023





Primary Outcome Measures :
  1. 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

  2. Colour Fundus (CF) [ Time Frame: Up to 96 weeks ]
    Change from baseline in Colour Fundus Photography measured in mm2

  3. Retinal Drusen Volume [ Time Frame: Up to 96 weeks ]
    Change from baseline in retinal drusen volume measured in mm3

  4. 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

  5. Retinal sensitivity [ Time Frame: Up to 96 weeks ]
    Change from baseline in retinal sensitivity as assessed by microperimetry

  6. 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

  7. Medical Events of Interest (MEI) [ Time Frame: Up to 96 weeks ]
    Change from baseline in percentage of Participants with MEI

  8. Monocular and Binocular Reading Performance [ Time Frame: Up to 96 weeks ]
    Change in Monocular and Binocular Reading Performance measured in words/min


Biospecimen Retention:   Samples With DNA
Saliva Samples, blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Secondary care.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894020


Contacts
Layout table for location contacts
Contact: Gyroscope Therapeutics +441438532142 clinicaltrials@gyroscopetx.com
Contact: Chief Medical Officer Gyroscope Therapeutics

  Show 38 Study Locations
Sponsors and Collaborators
Gyroscope Therapeutics

Layout table for additonal information
Responsible Party: Gyroscope Therapeutics
ClinicalTrials.gov Identifier: NCT03894020     History of Changes
Other Study ID Numbers: GTSCOPE
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Geographic Atrophy
Retinal Diseases
Retinal Degeneration
Atrophy
Eye Diseases
Pathological Conditions, Anatomical
Eye Diseases, Hereditary