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EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (EXPLORE)

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ClinicalTrials.gov Identifier: NCT04437368
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Gyroscope Therapeutics Limited

Brief Summary:
The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).

Condition or disease Intervention/treatment Phase
Dry Age-related Macular Degeneration Drug: GT005; Low Dose Drug: GT005; High Dose Phase 2

Detailed Description:

This is a Phase 2, outcomes assessor-masked, multicentre, randomised study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with GA secondary to AMD.

The trial includes a screening period of up to 8 weeks followed by a 96-week study period.

Subjects will be randomised to one of two groups: GT005 or the untreated control group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a Phase 2, outcomes assessor-masked multicentre, randomised study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with GA secondary to AMD.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The overall objectives of the study are to evaluate the safety and efficacy (anatomical and functional visual outcomes) of two doses of GT005 in genetically defined subjects with GA due to AMD.
Primary Purpose: Treatment
Official Title: EXPLORE: A Phase II, Outcomes Assessor-masked, Multicentre, Randomised Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
Actual Study Start Date : July 14, 2020
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GT005 Low Dose
Approximately 25 subjects are planned, with subjects randomised to GT005 Low Dose.
Drug: GT005; Low Dose
The study will test two doses of GT005: Low Dose and High Dose.

Experimental: GT005 High Dose
Approximately 25 subjects are planned, with subjects randomised to GT005 High Dose.
Drug: GT005; High Dose
The study will test two doses of GT005: Low Dose and High Dose.

No Intervention: Untreated control
Approximately 25 subjects are planned, with subjects randomised to untreated control.



Primary Outcome Measures :
  1. Progression of geographic atrophy [ Time Frame: 48 weeks ]
    The change from baseline to Week 48 in GA area as measured by fundus autofluorescence (FAF)


Secondary Outcome Measures :
  1. Progression of geographic atrophy [ Time Frame: 72 weeks and 96 weeks ]
    The change from baseline to Week 72 and Week 96 in GA area as measured by fundus autofluorescence (FAF)

  2. Evaluation of the safety and tolerability of GT005 [ Time Frame: 96 weeks ]
    Frequency of treatment emergent AEs

  3. Evaluation of the safety and tolerability of GT005 [ Time Frame: 96 weeks ]
    Change on ophthalmic examination

  4. Evaluation of the safety and tolerability of GT005 [ Time Frame: 96 weeks ]
    Change in imaging modalities

  5. Evaluation of the safety and tolerability of GT005 [ Time Frame: 96 weeks ]
    Change in best corrected visual acuity (BCVA)

  6. Evaluation of the effect of GT005 on retinal anatomical measures [ Time Frame: 96 weeks ]
    Change in retinal microstructures on optical coherence tomography (OCT)

  7. Evaluation of the effect of GT005 on retinal anatomical measures [ Time Frame: 96 weeks ]
    Change in presence of area of nascent GA on OCT

  8. Evaluation of the effect of GT005 on retinal anatomical measures [ Time Frame: 96 weeks ]
    Change in GA morphology on multimodal imaging

  9. Evaluation of the effect of GT005 on functional measures [ Time Frame: 96 weeks ]
    Macular sensitivity as assessed by mesopic Microperimetry

  10. Evaluation of the effect of GT005 on functional measures [ Time Frame: 96 weeks ]
    Change in BCVA Score via the early treatment for diabetic retinopathy (ETDRS) chart

  11. Evaluation of the effect of GT005 on functional measures [ Time Frame: 96 weeks ]
    Change in low luminance difference (LLD) via the ETDRS chart

  12. Evaluation of the effect of GT005 on visual function [ Time Frame: 96 weeks ]
    Change in reading performance as assessed by Minnesota low-vision reading test (MNRead) Chart

  13. Evaluation of the effect of GT005 on visual function [ Time Frame: 96 weeks ]
    Change in functional reading independence (FRI) index

  14. Evaluation of the effect of GT005 on patient-reported outcomes [ Time Frame: 96 weeks ]
    Change in quality of life measured on the Visual Functioning Questionnaire-25 (VFQ-25)



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 written informed consent
  2. Age ≥55 years
  3. Have a clinical diagnosis of GA secondary to AMD in the study eye, as determined by the Investigator, and a diagnosis of AMD in the contralateral eye
  4. GA lesion(s) within an acceptable size on FAF, in the study eye
  5. The GA lesion in the study eye must reside completely within the FAF image
  6. Have a BCVA of 24 letters (6/95 and 20/320 Snellen acuity equivalent) or better, using ETDRS charts, in the study eye
  7. Have a rare genetic variant of the CFI gene, defined as a minor allele frequency of <1%
  8. Able to attend all study visits and complete the study procedures
  9. Women of child-bearing potential must have a negative pregnancy test within 2 weeks prior to randomisation (not required for women who are postmenopausal or surgically sterilised)

Exclusion Criteria:

  1. Have evidence or history of CNV in either eye
  2. Presence of moderate/severe or worse non-proliferative diabetic retinopathy in the study eye
  3. Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in the study eye
  4. History of intraocular surgery in the study eye within 12 weeks prior to Screening.
  5. Have clinically significant cataract that may require surgery during the study period in the study eye. Presence of moderate to severe glaucomatous optic neuropathy in the study eye, uncontrolled intraocular pressure (IOP) despite the use of more than two topical agents, or a history of glaucoma-filtering or valve surgery
  6. Axial myopia of greater than -8 diopters in the study eye
  7. Have any other significant ocular or non-ocular medical or psychiatric condition which, in the opinion of the Investigator, may either put the subject at risk or may influence the results of the study
  8. Have a contraindication to the specified protocol corticosteroid regimen
  9. Have received any investigational product for the treatment of GA within the past 6 months, or 5 half-lives (whichever is longer) other than nutritional supplements such as the age-related eye disease study (AREDS) formula
  10. Have received a gene or cell therapy at any time
  11. Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant
  12. Active malignancy within the past 12 months, except for: appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer with a stable prostate-specific antigen (PSA) >12 months

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): NCT04437368


Contacts
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Contact: Gyroscope Therapeutics +441438532142 clinicaltrials@gyroscopetx.com

Locations
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Sponsors and Collaborators
Gyroscope Therapeutics Limited
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Responsible Party: Gyroscope Therapeutics Limited
ClinicalTrials.gov Identifier: NCT04437368    
Other Study ID Numbers: GT005-02
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gyroscope Therapeutics Limited:
Geographic atrophy
Retinal disease
Eye disease
Retinal degeneration
Macular atrophy
Dry age-related macular degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases