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FocuS: First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD

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ClinicalTrials.gov Identifier: NCT03846193
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Gyroscope Therapeutics Limited

Brief Summary:
This is an open label first in human Phase I/II multicentre study of GT005 in subjects with Macular Atrophy due to AMD

Condition or disease Intervention/treatment Phase
Dry Age-related Macular Degeneration Macular Degeneration Retinal Disease Eye Diseases Retinal Degeneration Geographic Atrophy Macular Atrophy Biological: GT005 Device: GT005 Phase 1 Phase 2

Detailed Description:
This study will evaluate the safety, the dose response and efficacy (anatomical and functional visual outcomes) of three doses of GT005 administered as a single subretinal injection in genetically defined subjects with Macular Atrophy due to Age-related Macular Degeneration (AMD). Following consent, subjects will undergo a number of ophthalmic and clinical assessments to determine eligibility for inclusion in the study. Once eligibility is confirmed, subjects will be enrolled, receive treatment, and will be followed for 48 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: A dose escalation study of the safety and efficacy of a single subretinal injection of GT005 in subjects with Macular Atrophy due to AMD
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FocuS: An Open Label First in Human Phase I/II Multicentre Study to Evaluate the Safety, Dose Response and Efficacy of GT005 Administered as a Single Subretinal Injection in Subjects With Macular Atrophy Due to AMD
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GT005 Dose 1
A single dose of GT005 will be administered via subretinal injection
Biological: GT005
A recombinant non-replicating adeno-associated viral (AAV) vector encoding a human complement factor

Experimental: GT005 Dose 2
A single dose of GT005 will be administered via subretinal injection
Biological: GT005
A recombinant non-replicating adeno-associated viral (AAV) vector encoding a human complement factor

Experimental: GT005 Dose 3
A single dose of GT005 will be administered via subretinal injection
Biological: GT005
A recombinant non-replicating adeno-associated viral (AAV) vector encoding a human complement factor

Experimental: GT005 Dose 1, 2 or 3
A single dose of GT005 will be administered via subretinal injection. This dose will be determined by dose levels determined to be tolerable in Arms 1,2 and 3
Biological: GT005
A recombinant non-replicating adeno-associated viral (AAV) vector encoding a human complement factor

Experimental: GT005 Dose 2 with Orbit Subretinal Delivery System
A single dose of GT005 will be administered with subretinal injection via suprachoroidal cannulation approach
Device: GT005
A recombinant non-replicating adeno-associated viral (AAV) vector encoding a human complement factor

Experimental: GT005 Dose 3 with Orbit Subretinal Delivery System
A single dose of GT005 will be administered with subretinal injection via suprachoroidal cannulation approach
Device: GT005
A recombinant non-replicating adeno-associated viral (AAV) vector encoding a human complement factor

Experimental: GT005 Dose 1, 2 or 3 with Orbit Subretinal Delivery Sysem
A single dose of GT005 will be administered with subretinal injection via suprachoroidal cannulation approach
Device: GT005
A recombinant non-replicating adeno-associated viral (AAV) vector encoding a human complement factor




Primary Outcome Measures :
  1. Incidence and severity of Treatment Emergent Adverse Events /Treatment Emergent Severe Adverse Events (TEAE/TESAE) [ Time Frame: 48 weeks ]
    Proportion of patients with TEAEs/TESAEs after subretinal injection of GT005


Secondary Outcome Measures :
  1. Geographic Atrophy [ Time Frame: 48 weeks ]
    Change from baseline in GA size measured in mm2

  2. Retinal Drusen Volume [ Time Frame: 48 weeks ]
    Change from baseline in GA size measured in mm3

  3. Macular Sensitivity [ Time Frame: 48 weeks ]
    Change from baseline in macular sensitivity measured in decibels (DB)

  4. Monocular Reading Speed [ Time Frame: 48 weeks ]
    Change from baseline in monocular reading speed measured in words/min

  5. Vector Shedding [ Time Frame: 48 weeks ]
    Change from baseline in vector titres measured in vector genome/ml

  6. Complement factors [ Time Frame: 48 weeks ]
    Change from baseline in levels of complement factors, measured in nanograms/ml



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Able and willing to give consent to study participation
  2. Presence of Bilateral GA due to AMD on Color Fundus Photography (CFP)
  3. Cohorts 1 to 3: GA lesions total size in the treatment eye must be

    ≥1.25mm2 and ≤17.5mm2

    Cohorts 4 to 7: GA lesions total size must be ≥1.25mm2 and ≤17.5mm2 for both eyes

  4. Cohorts 1 to 3: the GA lesion in the treatment eye must reside completely within the FAF fundus image

    Cohorts 4 to 7: The GA lesion must reside completely within the FAF fundus image for both eyes

  5. Cohorts 1 to 3: BCVA of ≤50 letters (6/36 Snellen acuity equivalent or worse) using ETDRS charts in the treatment eye

    Cohorts 4 to 7: BCVA of ≥24 letters (6/95 and 20/320 Snellen acuity equivalent or better) using ETDRS charts in both eyes

  6. Aged ≥55 years
  7. Able to attend all study visits and complete the study procedures

Exclusion Criteria

  1. Have evidence or history of choroidal neovascularization (CNV) in either eye
  2. Presence of moderate/severe or worse non-proliferative, diabetic retinopathy in either eye
  3. Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in either eye
  4. History of intraocular surgery in the study eye within 12 weeks prior to Screening (Visit 1). Yttrium aluminum garnet capsulotomy is permitted if performed >10 weeks prior to Visit 1
  5. Have clinically significant cataract that may require surgery during the study period in either eye
  6. Presence of moderate to severe glaucomatous optic neuropathy in either eye; uncontrolled IOP despite the use of more than two topical agents; a history of glaucoma-filtering or valve surgery is also excluded
  7. Axial myopia of greater than -8 diopters in the either eye
  8. Cohorts 5 to 7 only: presence of metallic objects or implanted stimulator devices in or near the head, including cochlear implants, deep brain stimulators, vagus nerve stimulators, and other implanted electrodes or stimulators

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): NCT03846193


Contacts
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Contact: Gyroscope Therapeutics Limited +4401438532142 clinicaltrials@gyroscopetx.com

Locations
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United States, Florida
Retina Vitreous Associates of Florida Not yet recruiting
Saint Petersburg, Florida, United States, 33711
United States, Iowa
Wolfe Eye Clinic Recruiting
West Des Moines, Iowa, United States, 50266
United States, Massachusetts
Ophthalamic Consultants of Boston (OCB) Recruiting
Boston, Massachusetts, United States, 02114
United States, Missouri
Pepose Vision Institute Recruiting
Chesterfield, Missouri, United States, 63017
United States, Nevada
Sierra Eye Associates Recruiting
Reno, Nevada, United States, 89502
United States, Ohio
Cincinnati Eye Institute Recruiting
Cincinnati, Ohio, United States, 45242
United States, Pennsylvania
Mid-Atlantic Retina Recruiting
Philadelphia, Pennsylvania, United States, 19107
United Kingdom
Bristol Eye Hospital Active, not recruiting
Bristol, United Kingdom
London Vision Clinic Active, not recruiting
London, United Kingdom, W1G 7LA
Moorfields Eye Hospital Active, not recruiting
London, United Kingdom
Manchester Eye Hospital Active, not recruiting
Manchester, United Kingdom
Oxford University Hospital Active, not recruiting
Oxford, United Kingdom
Sunderland Eye Infirmary Active, not recruiting
Sunderland, United Kingdom
Sponsors and Collaborators
Gyroscope Therapeutics Limited
Investigators
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Study Director: Chief Medical Officer Gyroscope Therapeutics Limited
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gyroscope Therapeutics Limited
ClinicalTrials.gov Identifier: NCT03846193    
Other Study ID Numbers: GT005-01
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gyroscope Therapeutics Limited:
Dry Age-related Macular Degeneration (Dry AMD)
AMD
Atrophic AMD
Geographic Atrophy (GA)
Dry-AMD
Dry AMD
Additional relevant MeSH terms:
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Macular Degeneration
Eye Diseases
Geographic Atrophy
Retinal Diseases
Retinal Degeneration
Anetoderma
Atrophy
Pathological Conditions, Anatomical
Eye Diseases, Hereditary
Connective Tissue Diseases
Skin Abnormalities
Skin Diseases