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 |
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Recruitment Status :
Recruiting
First Posted : June 18, 2020
Last Update Posted : December 5, 2022
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Sponsor:
Gyroscope Therapeutics Limited
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Gyroscope Therapeutics Limited
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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 |
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.
| 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 : | November 2, 2024 |
| Estimated Study Completion Date : | November 1, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
| Arm | Intervention/treatment |
|---|---|
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Experimental: GT005 Low Dose
Approximately 25 subjects are planned, with subjects randomised to GT005 Low Dose.
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Drug: GT005; Low Dose
The study will test two doses of GT005: Low Dose and High Dose. |
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Experimental: GT005 High Dose
Approximately 25 subjects are planned, with subjects randomised to GT005 High Dose.
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Drug: GT005; High Dose
The study will test two doses of GT005: Low Dose and High Dose. |
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No Intervention: Untreated control
Approximately 25 subjects are planned, with subjects randomised to untreated control.
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Primary Outcome Measures :
- 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 :
- 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)
- Evaluation of the safety and tolerability of GT005 [ Time Frame: 96 weeks ]Frequency of treatment emergent adverse events (AEs)
- Evaluation of the effect of GT005 on retinal anatomical measures [ Time Frame: 96 weeks ]Change in retinal microstructures on optical coherence tomography (OCT)
- Evaluation of the effect of GT005 on retinal anatomical measures [ Time Frame: 96 weeks ]Change in presence of area of nascent GA on OCT
- Evaluation of the effect of GT005 on retinal anatomical measures [ Time Frame: 96 weeks ]Change in GA morphology on multimodal imaging
- Evaluation of the effect of GT005 on functional measures [ Time Frame: 96 weeks ]Macular sensitivity as assessed by mesopic Microperimetry
- 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
- Evaluation of the effect of GT005 on functional measures [ Time Frame: 96 weeks ]Change in low luminance difference (LLD) via the ETDRS chart
- 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
- Evaluation of the effect of GT005 on visual function [ Time Frame: 96 weeks ]Change in functional reading independence (FRI) index
- 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)
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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:
- Able and willing to give written informed consent
- Age ≥55 years
- 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
- GA lesion(s) within an acceptable size on FAF, in the study eye
- The GA lesion(s) in the study eye must reside completely within the FAF image
- Up to 25% of the enrolled study population are permitted to have CNV in the fellow eye
- Have a BCVA of 24 letters (6/95 and 20/320 Snellen acuity equivalent) or better, using ETDRS charts, in the study eye
- Have a rare genetic variant of the CFI gene, defined as a minor allele frequency of <1%
- Able to attend all study visits and complete the study procedures
- 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:
- Have a history, or evidence, of CNV in the study eye
- Presence of moderate/severe or worse non-proliferative diabetic retinopathy in the study eye
- Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in the study eye
- History of intraocular surgery in the study eye within 12 weeks prior to Screening.
- 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
- Axial myopia of greater than -8 diopters in the study eye
- 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
- Have a contraindication to the specified protocol corticosteroid regimen
- 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
- Have received a gene or cell therapy at any time
- Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant
- 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
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novartis.email@novartis.com |
Locations
Show 32 study locations
Sponsors and Collaborators
Gyroscope Therapeutics Limited
Novartis Pharmaceuticals
| 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: | December 5, 2022 |
| Last Verified: | December 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Gyroscope Therapeutics Limited:
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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 |