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Trial record 1 of 3 for:    GT005
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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 : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Gyroscope Therapeutics

Tracking Information
First Submitted Date  ICMJE June 3, 2020
First Posted Date  ICMJE June 18, 2020
Last Update Posted Date January 25, 2021
Actual Study Start Date  ICMJE July 14, 2020
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2020)
Progression of geographic atrophy [ Time Frame: 48 weeks ]
The change from baseline to Week 48 in GA area as measured by fundus fluorescence (FAF)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2020)
  • Evaluation of the safety and tolerability of GT005 [ Time Frame: 48 weeks ]
    Frequency of treatment emergent AEs
  • Evaluation of the safety and tolerability of GT005 [ Time Frame: 48 weeks ]
    Change on ophthalmic examination
  • Evaluation of the safety and tolerability of GT005 [ Time Frame: 48 weeks ]
    Change in imaging modalities
  • Evaluation of the safety and tolerability of GT005 [ Time Frame: 48 weeks ]
    Change in best corrected visual acuity (BCVA)
  • Evaluation of the effect of GT005 on retinal anatomical measures [ Time Frame: 48 weeks ]
    Change in retinal microstructures on spectral domain optical coherence tomography (SD-OCT)
  • Evaluation of the effect of GT005 on retinal anatomical measures [ Time Frame: 48 weeks ]
    Change in presence of area of nascent GA on SD-OCT
  • Evaluation of the effect of GT005 on retinal anatomical measures [ Time Frame: 48 weeks ]
    Change in GA morphology on colour fundus photography (CFP)
  • Evaluation of the effect of GT005 on functional measures [ Time Frame: 48 weeks ]
    Macular sensitivity as assessed by mesopic Microperimetry
  • Evaluation of the effect of GT005 on functional measures [ Time Frame: 48 weeks ]
    Change in BCVA Score via the early treatment for diabetic retinopathy (ETDRS) chart
  • Evaluation of the effect of GT005 on functional measures [ Time Frame: 48 weeks ]
    Change in low luminance difference (LLD) via the ETDRS chart
  • Evaluation of the effect of GT005 on visual function [ Time Frame: 48 weeks ]
    Change in reading performance as assessed by Minnesota low-vision reading test (MNRead) Chart
  • Evaluation of the effect of GT005 on visual function [ Time Frame: 48 weeks ]
    Change in functional reading independence (FRI) index
  • Evaluation of the effect of GT005 on patient-reported outcomes [ Time Frame: 48 weeks ]
    Change in quality of life measured on the Visual Functioning Questionnaire-25 (VFQ-25)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005
Official Title  ICMJE 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
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).
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 48-week study period.

Subjects will be randomised to two groups; GT005 or the untreated control group.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Dry Age-related Macular Degeneration
Intervention  ICMJE
  • Drug: GT005; Dose 1
    The study will test two doses of GT005; Dose 1 and Dose 2.
  • Drug: GT005; Dose 2
    The study will test two doses of GT005; Dose 1 and Dose 2.
Study Arms  ICMJE
  • Experimental: GT005 Dose 1
    Approximately 25 subjects are planned, with subjects randomised to GT005 Dose 1.
    Intervention: Drug: GT005; Dose 1
  • Experimental: GT005 Dose 2
    Approximately 25 subjects are planned, with subjects randomised to GT005 Dose 2.
    Intervention: Drug: GT005; Dose 2
  • No Intervention: Untreated control
    Approximately 25 subjects are planned, with subjects randomised to untreated control.
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  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2020)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2023
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 as determined by the Investigator
  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 34 letters (6/60 and 20/200 Snellen acuity equivalent) or better, using ETDRS charts, in the study eye
  7. Serum Complement Factor I level below the lower limit of normal of the selected assay
  8. Have a rare genetic variant of the CFI gene, defined as a minor allele frequency of <1%
  9. Able to attend all study visits and complete the study procedures
  10. Women of child-bearing potential must have a negative pregnancy test within 2 weeks prior to randomisation

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. Have clinically significant cataract that may require surgery during the study period in the study eye
  5. Presence of moderate to severe glaucomatous optic neuropathy in the study eye, uncontrolled intraocular pressure (IOP), use of two or more topical agents to control IOP, or a history of glaucoma-filtering 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 oral prednisolone/prednisone
  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 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. Have a history or presence of cutaneous squamous cell carcinoma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gyroscope Therapeutics +441438532142 clinicaltrials@gyroscopetx.com
Listed Location Countries  ICMJE Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04437368
Other Study ID Numbers  ICMJE GT005-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gyroscope Therapeutics
Study Sponsor  ICMJE Gyroscope Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gyroscope Therapeutics
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP