HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005

  • STATUS
    Recruiting
  • End date
    Oct 31, 2023
  • participants needed
    180
  • sponsor
    Gyroscope Therapeutics Limited
Updated on 9 September 2021

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).

Description

This is a Phase 2, open-label, outcomes-assessor masked, multicentre, randomised, controlled 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 and a 96-week study period.

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

Details
Condition Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Dry Age-related Macular Degeneration
Treatment GT005: Dose 1, GT005: Dose 2, GT005: Medium Dose, GT005: High Dose
Clinical Study IdentifierNCT04566445
SponsorGyroscope Therapeutics Limited
Last Modified on9 September 2021

Eligibility

Yes No Not Sure

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 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 or 20/320 Snellen acuity equivalent), using ETDRS charts, in the study eye
Meet one of the pre-specified AMD genetic subgroup criteria
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 postmenopausal women) or provide documentation of being surgically sterilised

Exclusion Criteria

Carriers of excluded genetic variants
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
Have clinically significant cataract that may require surgery during the study period in the study eye
History of intraocular surgery in the study eye within 12 weeks prior to Visit 1
Axial myopia of greater than -8 diopters in the study eye
Presence of moderate to severe glaucomatous optic neuropathy, uncontrolled intraocular pressure (IOP), despite use of two or more topical agents; or a history of glaucoma-filtering or valve surgery
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
Have a contraindication to the protocol specified corticosteroid regimen
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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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